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Shifting Perspectives: Enhancing Outcomes in Anorexia Nervosa With CRT

Shifting Perspectives: Enhancing Outcomes in Adolescent Anorexia Nervosa With Cognitive Remediation Therapy (CRT)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03928028
Enrollment
177
Registered
2019-04-25
Start date
2019-04-01
Completion date
2021-06-24
Last updated
2023-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Brief summary

Anorexia Nervosa is a serious life-threatening illness with a typical age of onset in adolescence; if not effectively treated, it has the potential to significantly impact adolescent development and quality of life. Research on executive functioning in anorexia nervosa indicates that it may be a viable target for intervention that could improve outcome. The current project focuses on determining whether or not the investigators can improve set-shifting in parents and affected adolescents in the hopes that improvements in set-shifting will, ultimately, improve outcome.

Detailed description

This application seeks support for a phased project. In the initial (R61) 2-year phase, the investigators will establish that Cognitive Remediation Therapy (CRT) can increase set-shifting in parents of and/or adolescents with Anorexia Nervosa (AN). The second aim is to determine the appropriate dose needed to achieve positive change in set-shifting. Attaining this milestone would trigger support for three additional years (R33) to confirm target engagement and appropriate dose. The investigators will also evaluate whether or not adding CRT to Family Based Treatment (FBT) will improve outcome compared to FBT alone. Set-shifting (a type of executive functioning often referred to as cognitive flexibility) inefficiencies are hypothesized to be an endophenotype of AN and are, therefore, heritable. Cognitive flexibility can be impacted negatively by situational factors such as malnutrition, stress, and anxiety. It is likely that both adolescents (who are malnourished) and parents (who are under stress) experience significant state-based reduction in their cognitive flexibility during AN and its treatment. While cognitive flexibility can be increased through CRT, there is a significant gap in the knowledge about how to apply CRT to the treatment of adolescent AN, specifically concerning the most appropriate target for CRT: parents or adolescents? The majority of research on CRT with adolescents with AN are pilot and feasibility studies and target set-shifting in adolescents, not parents. The investigators hypothesize that targeting parents may be more impactful for adolescent outcome. First, the investigators must determine if an increase set-shifting via CRT is possible. In the initial R61 phase, the investigators propose to recruit and randomly assign 54 families who have a child with AN to FBT, FBT with parent-focused CRT, or FBT with adolescent-focused CRT. Target engagement will be assessed via neuro-psychological assessment and self-report of cognitive and behavioral flexibility. If the investigators meet these proposed milestones in the R61 phase, they will proceed to the R33 phase. It is possible that one (N = 72 families) or both (N = 93 families) CRT conditions will be examined in the R33 phase. The investigators will confirm the findings from the R61 phase (target engagement and dose of CRT). The investigators will also examine adolescent outcome in FBT alone versus FBT+(parent or adolescent) CRT. They will gather preliminary data on putative moderators and/or mediators across both phases in order to inform results. This phased R61/R33 application is innovative in that it is the first to adapt CRT to parents only. Evidence supporting FBT+CRT to increase set-shifting in parents/adolescents will inform future efforts to leverage understanding of (heritable) neurobiology of AN in adolescents to improve outcome. Further, if CRT for parents significantly improves set-shifting, the investigators can focus efforts on how best to augment current treatments, support parents, and increase positive outcomes for the adolescent and reduce relapse. Even negative results would inform understanding of set-shifting inefficiencies as an endophenotype in AN, its measurement, and usefulness as a target in treatment.

Interventions

BEHAVIORALCognitive Remediation Therapy

Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.

Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Any study team member who is assessing for outcomes will not which participant/family is in which group.

Intervention model description

Random assignment to one of three groups.

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adolescents 1. Age 12-18 2. Currently meets Diagnostic and Statistical Manual-5 criteria for Anorexia Nervosa 3. Medically stable for outpatient treatment 4. Fluent in English 5. No co-morbid condition that would exclude participation 6. Medical clearance from primary care physician and permission to speak to Primary Care Physician about clinical issues 7. Biological parent or primary caregiver willing to engage in treatment and who live with the adolescent Inclusion Criteria:Parents 1. Age \>18 2. Child with a diagnoses of AN 3. Both parents willing to participate 4. Fluent in English 5. No co-morbid condition that would exclude participation

Exclusion criteria

Adolescent 1. Adolescent outside age range 2. Adolescent adopted 3. Pregnant adolescent 4. Presence of: pervasive developmental disability, psychosis, bipolar disorder, substance abuse, autism spectrum disorder, or intellectual disability 5. Presence of: a brain disorder or injury (such as TBI) that could impact the ability to engage in treatment 6. Use of anti-psychotic medication 7. Concurrent psychosocial therapy

Design outcomes

Primary

MeasureTime frameDescription
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS6 months of treatmentThe Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Trail Making Test assesses flexibility in thinking. We use Condition 4 (Number-Letter Switching) to assess flexibility.
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS6 months of treatmentThe Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Inhibition refers to the ability to inhibit a well learned or salient task in order to do something different; thus, it is related to flexibility. The D-KEFS Color-Word Interference Test (Condition 3: Inhibition) to assess ability to inhibit automatic responses.
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS6 months of treatmentThe Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Color Word Interference (Condition 4: Inhibition/Switching) assess the ability to switch between alternating rules (a component of set shifting).
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS6 months of treatmentThe Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Verbal Fluency assesses the ability to shift between concepts. The Switching Correct score is used to assess flexibility.
Change in Cognitive Flexibility - Sorting Test Description of DKEFS6 months of treatmentThe Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The Sorting Test assesses flexibility in thinking and problem solving.
Change in Self-Reported Shifting - BRIEF6 months of treatmentThe Behavior Rating Inventory of Executive Functioning (BRIEF) is an ecologically valid clinical tool for measuring executive functioning across several domains in youth 5 to 18 years of age; the self-report version (BRIEF-2) was administered to adolescents. It has a comparable adult self-report version (BRIEF-A) normed for ages 18-90. Both versions of the BRIEF are normed by age and sex on a T-scale (mean = 50, SD = 10), and scores are considered clinically elevated if they are 65 or higher. Both have a number of clinical scales and indices. Lower scores indicate greater strengths in each area. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants, thus, we expect a reduction in scores for those in the CRT conditions. The BRIEF was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The BRIEF Shift assesses behavioral flexibility.
Dose of CRT6 months of treatmentNumber of sessions necessary in order to change cognitive flexibility. This is the number of sessions needed for change to occur in cognitive flexibility. It is only calculated for the participants who received CRT and who had a significant change in flexibility above what was observed in FBT.

Countries

United States

Participant flow

Participants by arm

ArmCount
Family Based Treatment (FBT)
Families will receive 15 sessions of FBT alone. Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
63
FBT w/ Parent-focused Cognitive Remediation Therapy
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months. Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition. Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
57
FBT w/Adolescent-focused Cognitive Remediation Therapy
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months. Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition. Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
57
Total177

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyPhysician Decision963
Overall StudyWithdrawal by Subject1233

Baseline characteristics

CharacteristicFamily Based Treatment (FBT)FBT w/ Parent-focused Cognitive Remediation TherapyFBT w/Adolescent-focused Cognitive Remediation TherapyTotal
Age, Categorical
<=18 years
21 Participants19 Participants19 Participants59 Participants
Age, Categorical
>=65 years
0 Participants1 Participants0 Participants1 Participants
Age, Categorical
Between 18 and 65 years
42 Participants37 Participants38 Participants117 Participants
Age, Continuous
Adolescents
15.51 years
STANDARD_DEVIATION 1.81
15.21 years
STANDARD_DEVIATION 1.53
15.25 years
STANDARD_DEVIATION 1.61
15.335 years
STANDARD_DEVIATION 1.641
Age, Continuous
Fathers
50.65 years
STANDARD_DEVIATION 5.98
49.93 years
STANDARD_DEVIATION 6.82
48.97 years
STANDARD_DEVIATION 4.82
49.88 years
STANDARD_DEVIATION 5.87
Age, Continuous
Mothers
48.18 years
STANDARD_DEVIATION 3.61
47.46 years
STANDARD_DEVIATION 6.25
47.30 years
STANDARD_DEVIATION 2.997
47.66 years
STANDARD_DEVIATION 4.42
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants1 Participants0 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
58 Participants54 Participants55 Participants167 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants2 Participants2 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants6 Participants0 Participants6 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants3 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants2 Participants1 Participants7 Participants
Race (NIH/OMB)
White
58 Participants49 Participants53 Participants160 Participants
Region of Enrollment
United States
63 Participants57 Participants57 Participants177 Participants
Sex: Female, Male
Female
39 Participants36 Participants35 Participants110 Participants
Sex: Female, Male
Male
24 Participants21 Participants22 Participants67 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 630 / 570 / 57
other
Total, other adverse events
0 / 631 / 570 / 57
serious
Total, serious adverse events
0 / 630 / 570 / 57

Outcome results

Primary

Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS

The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Color Word Interference (Condition 4: Inhibition/Switching) assess the ability to switch between alternating rules (a component of set shifting).

Time frame: 6 months of treatment

Population: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T111.71 score on a scaleStandard Deviation 1.101
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T312.78 score on a scaleStandard Deviation 1.215
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T412.75 score on a scaleStandard Deviation 1.844
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T513.83 score on a scaleStandard Deviation 1.467
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T111.67 score on a scaleStandard Deviation 2.106
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T312.56 score on a scaleStandard Deviation 1.504
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T412.86 score on a scaleStandard Deviation 2.07
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T513.09 score on a scaleStandard Deviation 1.446
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T111.52 score on a scaleStandard Deviation 2.994
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T312.59 score on a scaleStandard Deviation 2.763
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T413.60 score on a scaleStandard Deviation 1.957
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T514.17 score on a scaleStandard Deviation 1.03
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T513.71 score on a scaleStandard Deviation 2.016
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T111.05 score on a scaleStandard Deviation 1.615
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T413.19 score on a scaleStandard Deviation 1.515
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T111.63 score on a scaleStandard Deviation 2.385
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T312.50 score on a scaleStandard Deviation 1.633
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T313.13 score on a scaleStandard Deviation 1.088
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T413.50 score on a scaleStandard Deviation 2.16
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T412.63 score on a scaleStandard Deviation 1.586
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T513.73 score on a scaleStandard Deviation 1.033
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T112.05 score on a scaleStandard Deviation 1.433
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T513.13 score on a scaleStandard Deviation 1.356
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T313.00 score on a scaleStandard Deviation 1.751
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T513.40 score on a scaleStandard Deviation 1.549
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T111.37 score on a scaleStandard Deviation 2.929
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T312.35 score on a scaleStandard Deviation 2.262
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T312.56 score on a scaleStandard Deviation 1.79
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T412.94 score on a scaleStandard Deviation 1.391
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSFather - T513.00 score on a scaleStandard Deviation 1.414
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T413.29 score on a scaleStandard Deviation 2.114
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T111.95 score on a scaleStandard Deviation 2.041
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T312.78 score on a scaleStandard Deviation 1.7
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T111.61 score on a scaleStandard Deviation 1.914
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSMother - T413.35 score on a scaleStandard Deviation 1.801
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFSAdolescent - T513.27 score on a scaleStandard Deviation 2.154
Comparison: This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRTp-value: 0.778generalized estimating equation
Comparison: This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRTp-value: 0.297generalized estimating equation
Comparison: This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRTp-value: 0.062generalized estimating equation
Primary

Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS

The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Trail Making Test assesses flexibility in thinking. We use Condition 4 (Number-Letter Switching) to assess flexibility.

Time frame: 6 months of treatment

Population: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSMother- T111.89 score on a scaleStandard Deviation 0.875
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSMother - T311.14 score on a scaleStandard Deviation 2.742
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSMother - T412.18 score on a scaleStandard Deviation 0.874
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS1Mother - T512.75 score on a scaleStandard Deviation 1.165
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T111.14 score on a scaleStandard Deviation 2.265
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T311.92 score on a scaleStandard Deviation 1.382
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T411.82 score on a scaleStandard Deviation 2.136
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T512.14 score on a scaleStandard Deviation 1.069
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T19.47 score on a scaleStandard Deviation 3.151
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T39.50 score on a scaleStandard Deviation 3.555
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T411.00 score on a scaleStandard Deviation 2.404
Family Based Treatment (FBT)Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T512.50 score on a scaleStandard Deviation 1.414
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T512.33 score on a scaleStandard Deviation 1.225
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSMother- T110.94 score on a scaleStandard Deviation 2.331
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T413.10 score on a scaleStandard Deviation 1.101
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T110.59 score on a scaleStandard Deviation 2.033
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSMother - T311.86 score on a scaleStandard Deviation 2.107
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T312.57 score on a scaleStandard Deviation 1.342
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T412.50 score on a scaleStandard Deviation 0.85
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSMother - T412.70 score on a scaleStandard Deviation 0.675
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T512.80 score on a scaleStandard Deviation 0.919
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T111.06 score on a scaleStandard Deviation 1.819
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS1Mother - T513.11 score on a scaleStandard Deviation 0.782
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T311.71 score on a scaleStandard Deviation 1.773
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS1Mother - T513.25 score on a scaleStandard Deviation 1.708
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T111.35 score on a scaleStandard Deviation 2.06
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T310.83 score on a scaleStandard Deviation 1.115
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T312.23 score on a scaleStandard Deviation 1.092
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T412.09 score on a scaleStandard Deviation 1.64
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSFather - T513.00 score on a scaleStandard Deviation 1.549
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T411.64 score on a scaleStandard Deviation 1.567
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSMother- T111.47 score on a scaleStandard Deviation 1.663
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSMother - T312.00 score on a scaleStandard Deviation 1.663
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T110.94 score on a scaleStandard Deviation 1.144
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSMother - T412.27 score on a scaleStandard Deviation 1.191
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFSAdolescent - T511.50 score on a scaleStandard Deviation 1.643
Comparison: This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRTp-value: 0.507generalized estimating equation
Comparison: This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRTp-value: 0.017generalized estimating equation
Comparison: This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRTp-value: 0.139generalized estimating equation
Primary

Change in Cognitive Flexibility - Sorting Test Description of DKEFS

The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The Sorting Test assesses flexibility in thinking and problem solving.

Time frame: 6 months of treatment

Population: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T111.94 score on a scaleStandard Deviation 3.334
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T312.21 score on a scaleStandard Deviation 2.119
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T412.80 score on a scaleStandard Deviation 1.814
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T513.86 score on a scaleStandard Deviation 1.464
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T111.80 score on a scaleStandard Deviation 2.331
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T312.15 score on a scaleStandard Deviation 2.478
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T412.50 score on a scaleStandard Deviation 2.224
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T514.00 score on a scaleStandard Deviation 1.789
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T111.37 score on a scaleStandard Deviation 2.712
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T311.33 score on a scaleStandard Deviation 2.229
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T413.22 score on a scaleStandard Deviation 1.856
Family Based Treatment (FBT)Change in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T512.171 score on a scaleStandard Deviation 0.488
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T512.00 score on a scaleStandard Deviation 2.582
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T111.47 score on a scaleStandard Deviation 1.972
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T414.00 score on a scaleStandard Deviation 2.404
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T111.65 score on a scaleStandard Deviation 1.693
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T312.38 score on a scaleStandard Deviation 1.446
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T313.85 score on a scaleStandard Deviation 2.478
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T412.20 score on a scaleStandard Deviation 2.044
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T414.00 score on a scaleStandard Deviation 2.449
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T514.60 score on a scaleStandard Deviation 2.366
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T112.94 score on a scaleStandard Deviation 2.358
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T513.22 score on a scaleStandard Deviation 1.787
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T311.54 score on a scaleStandard Deviation 1.808
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T516.25 score on a scaleStandard Deviation 1.258
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T112.35 score on a scaleStandard Deviation 2.29
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T311.00 score on a scaleStandard Deviation 2.793
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T312.92 score on a scaleStandard Deviation 1.676
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T412.82 score on a scaleStandard Deviation 2.136
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSFather - T515.00 score on a scaleStandard Deviation 1.414
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T411.27 score on a scaleStandard Deviation 1.902
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T112.47 score on a scaleStandard Deviation 1.7
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T313.50 score on a scaleStandard Deviation 2.68
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T110.35 score on a scaleStandard Deviation 2.737
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSMother - T414.00 score on a scale
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Sorting Test Description of DKEFSAdolescent - T511.17 score on a scaleStandard Deviation 2.483
Comparison: This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRTp-value: 0.446generalized estimating equation
Comparison: This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRTp-value: 0.647generalized estimating equation
Comparison: This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRTp-value: 0.765generalized estimating equation
Primary

Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS

The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Verbal Fluency assesses the ability to shift between concepts. Switching Accuracy assesses the number of times an accurate switch between categories occurs.

Time frame: 6 months of treatment

Population: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T414.06 score on a scaleStandard Deviation 3.043
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T311.56 score on a scaleStandard Deviation 1.617
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T111.90 score on a scaleStandard Deviation 3.567
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T412.20 score on a scaleStandard Deviation 3.299
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T511.58 score on a scaleStandard Deviation 1.975
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T512.00 score on a scaleStandard Deviation 1.758
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T111.81 score on a scaleStandard Deviation 3.628
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T311.63 score on a scaleStandard Deviation 2.929
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T311.68 score on a scaleStandard Deviation 3.528
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T412.71 score on a scaleStandard Deviation 4.286
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T512.45 score on a scaleStandard Deviation 2.911
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T111.45 score on a scaleStandard Deviation 3.634
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T511.21 score on a scaleStandard Deviation 2.155
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T111.95 score on a scaleStandard Deviation 2.549
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T412.63 score on a scaleStandard Deviation 3.284
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T110.37 score on a scaleStandard Deviation 3.89
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T312.19 score on a scaleStandard Deviation 1.559
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T412.06 score on a scaleStandard Deviation 3.958
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T111.68 score on a scaleStandard Deviation 3.637
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T412.13 score on a scaleStandard Deviation 2.9
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T311.13 score on a scaleStandard Deviation 2.705
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T311.56 score on a scaleStandard Deviation 1.59
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T512.00 score on a scaleStandard Deviation 1.414
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T512.07 score on a scaleStandard Deviation 1.335
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T511.93 score on a scaleStandard Deviation 1.486
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T111.95 score on a scaleStandard Deviation 4.183
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T311.24 score on a scaleStandard Deviation 2.166
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T413.65 score on a scaleStandard Deviation 3.968
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T111.50 score on a scaleStandard Deviation 2.854
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T311.56 score on a scaleStandard Deviation 2.549
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T412.00 score on a scaleStandard Deviation 3.386
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T511.53 score on a scaleStandard Deviation 1.846
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T111.28 score on a scaleStandard Deviation 2.321
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T310.88 score on a scaleStandard Deviation 2.233
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T410.18 score on a scaleStandard Deviation 4.261
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T512.13 score on a scaleStandard Deviation 1.356
Comparison: This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRTp-value: 0.196generalized estimating equation
Comparison: This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRTp-value: 0.812generalized estimating equation
Comparison: This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRTp-value: 0.499generalized estimating equation
Primary

Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS

The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Verbal Fluency assesses the ability to shift between concepts. The Switching Correct score is used to assess flexibility.

Time frame: 6 months of treatment

Population: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T512.45 score on a scaleStandard Deviation 2.911
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T312.47 score on a scaleStandard Deviation 3.717
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T111.55 score on a scaleStandard Deviation 3.677
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T310.89 score on a scaleStandard Deviation 3.411
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T511.92 score on a scaleStandard Deviation 4.033
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T411.80 score on a scaleStandard Deviation 3.707
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T413.00 score on a scaleStandard Deviation 4.195
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T512.42 score on a scaleStandard Deviation 3.288
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T111.81 score on a scaleStandard Deviation 3.628
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T112.10 score on a scaleStandard Deviation 3.478
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T311.68 score on a scaleStandard Deviation 3.528
Family Based Treatment (FBT)Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T412.71 score on a scaleStandard Deviation 4.286
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T311.50 score on a scaleStandard Deviation 3.759
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T513.53 score on a scaleStandard Deviation 2.446
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T511.36 score on a scaleStandard Deviation 2.59
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T112.42 score on a scaleStandard Deviation 3.006
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T312.44 score on a scaleStandard Deviation 3.444
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T111.95 score on a scaleStandard Deviation 2.718
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T312.31 score on a scaleStandard Deviation 3.135
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T110.68 score on a scaleStandard Deviation 3.973
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T411.88 score on a scaleStandard Deviation 3.757
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T412.47 score on a scaleStandard Deviation 2.722
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T511.43 score on a scaleStandard Deviation 3.694
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T412.44 score on a scaleStandard Deviation 3.464
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T511.80 score on a scaleStandard Deviation 2.513
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T111.74 score on a scaleStandard Deviation 4.483
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T311.18 score on a scaleStandard Deviation 3.695
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T513.47 score on a scaleStandard Deviation 2.949
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T110.63 score on a scaleStandard Deviation 3.218
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T311.33 score on a scaleStandard Deviation 4.102
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T412.00 score on a scaleStandard Deviation 3.386
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSFather - T511.73 score on a scaleStandard Deviation 4.399
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T111.50 score on a scaleStandard Deviation 1.917
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T39.88 score on a scaleStandard Deviation 3.967
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSAdolescent - T49.41 score on a scaleStandard Deviation 4.459
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Cognitive Flexibility - Verbal Fluency Switching of DKEFSMother - T413.29 score on a scaleStandard Deviation 4.089
Comparison: This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRTp-value: 0.069generalized estimating equation
Comparison: This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRTp-value: 0.323generalized estimating equation
Comparison: This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRTp-value: 0.225generalized estimating equation
Primary

Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS

The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Inhibition refers to the ability to inhibit a well learned or salient task in order to do something different; thus, it is related to flexibility. The D-KEFS Color-Word Interference Test (Condition 3: Inhibition) to assess ability to inhibit automatic responses.

Time frame: 6 months of treatment

Population: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother - T312.72 score on a scaleStandard Deviation 1.565
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother - T513.67 score on a scaleStandard Deviation 1.923
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent - T311.47 score on a scaleStandard Deviation 2.348
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent - T412.67 score on a scaleStandard Deviation 1.676
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent - T512.83 score on a scaleStandard Deviation 1.642
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother -T111.95 score on a scaleStandard Deviation 2.291
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T111.14 score on a scaleStandard Deviation 2.689
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T311.94 score on a scaleStandard Deviation 1.798
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother - T413.06 score on a scaleStandard Deviation 1.436
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T412.43 score on a scaleStandard Deviation 1.742
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T512.55 score on a scaleStandard Deviation 1.753
Family Based Treatment (FBT)Change in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent-T110.76 score on a scaleStandard Deviation 2.3
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother - T412.25 score on a scaleStandard Deviation 1.528
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent-T111.95 score on a scaleStandard Deviation 2.272
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T112.11 score on a scaleStandard Deviation 1.941
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T412.75 score on a scaleStandard Deviation 2.84
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent - T312.94 score on a scaleStandard Deviation 1.482
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother - T512.93 score on a scaleStandard Deviation 1.668
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother -T111.84 score on a scaleStandard Deviation 1.608
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent - T413.31 score on a scaleStandard Deviation 1.448
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother - T312.06 score on a scaleStandard Deviation 1.237
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T513.67 score on a scaleStandard Deviation 1.291
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent - T513.14 score on a scaleStandard Deviation 1.61
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T313.06 score on a scaleStandard Deviation 1.436
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent - T513.00 score on a scaleStandard Deviation 2.204
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother -T112.21 score on a scaleStandard Deviation 2.175
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother - T312.94 score on a scaleStandard Deviation 2.014
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother - T413.12 score on a scaleStandard Deviation 1.996
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSMother - T513.33 score on a scaleStandard Deviation 1.718
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T111.63 score on a scaleStandard Deviation 2.52
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T312.50 score on a scaleStandard Deviation 2.176
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T413.00 score on a scaleStandard Deviation 1.581
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSFather - T512.80 score on a scaleStandard Deviation 1.74
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent-T111.11 score on a scaleStandard Deviation 3.008
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent - T31.35 score on a scaleStandard Deviation 2.548
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Inhibition - Condition 3 of Color-Word Interference, DKEFSAdolescent - T412.76 score on a scaleStandard Deviation 2.412
Comparison: This analysis compare mothers in FBT to mothers in FBT+CRTpp-value: 0.389generalized estimating equation
Comparison: This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRTp-value: 0.447generalized estimating equation
Comparison: This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRTp-value: <0.001generalized estimating equation
Primary

Change in Self-Reported Shifting - BRIEF

The Behavior Rating Inventory of Executive Functioning (BRIEF) is an ecologically valid clinical tool for measuring executive functioning across several domains in youth 5 to 18 years of age; the self-report version (BRIEF-2) was administered to adolescents. It has a comparable adult self-report version (BRIEF-A) normed for ages 18-90. Both versions of the BRIEF are normed by age and sex on a T-scale (mean = 50, SD = 10), and scores are considered clinically elevated if they are 65 or higher. Both have a number of clinical scales and indices. Lower scores indicate greater strengths in each area. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants, thus, we expect a reduction in scores for those in the CRT conditions. The BRIEF was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The BRIEF Shift assesses behavioral flexibility.

Time frame: 6 months of treatment

Population: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFMother - T158.38 score on a scaleStandard Deviation 6.953
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFMother - T356.47 score on a scaleStandard Deviation 8.65
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFMother - T456.07 score on a scaleStandard Deviation 9.996
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFMother - T555.92 score on a scaleStandard Deviation 8.361
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFFather - T150.67 score on a scaleStandard Deviation 11.625
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFFather - T352.17 score on a scaleStandard Deviation 11.658
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFFather - T450.71 score on a scaleStandard Deviation 9.98
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFFather - T547.55 score on a scaleStandard Deviation 7.381
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFAdolescent - T160.86 score on a scaleStandard Deviation 9.926
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFAdolescent - T358.71 score on a scaleStandard Deviation 12.494
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFAdolescent - T460.36 score on a scaleStandard Deviation 12.125
Family Based Treatment (FBT)Change in Self-Reported Shifting - BRIEFAdolescent - T558.18 score on a scaleStandard Deviation 10.226
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFAdolescent - T550.38 score on a scaleStandard Deviation 9.726
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFMother - T153.21 score on a scaleStandard Deviation 7.843
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFFather - T459.25 score on a scaleStandard Deviation 8.993
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFAdolescent - T155.58 score on a scaleStandard Deviation 12.389
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFMother - T356.31 score on a scaleStandard Deviation 11.001
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFFather - T359.69 score on a scaleStandard Deviation 8.592
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFAdolescent - T452.50 score on a scaleStandard Deviation 11.77
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFMother - T455.75 score on a scaleStandard Deviation 12.557
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFFather - T557.13 score on a scaleStandard Deviation 10.453
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFFather - T159.58 score on a scaleStandard Deviation 9.924
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFMother - T555.67 score on a scaleStandard Deviation 12.21
FBT w/ Parent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFAdolescent - T355.13 score on a scaleStandard Deviation 11.618
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFMother - T553.27 score on a scaleStandard Deviation 11.823
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFFather - T153.43 score on a scaleStandard Deviation 9.3
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFAdolescent - T355.59 score on a scaleStandard Deviation 11.571
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFFather - T346.63 score on a scaleStandard Deviation 7.94
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFFather - T447.25 score on a scaleStandard Deviation 8.103
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFFather - T548.07 score on a scaleStandard Deviation 8.681
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFAdolescent - T454.82 score on a scaleStandard Deviation 12.812
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFMother - T151.79 score on a scaleStandard Deviation 9.92
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFMother - T354.28 score on a scaleStandard Deviation 11.509
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFAdolescent - T158.16 score on a scaleStandard Deviation 10.399
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFMother - T452.94 score on a scaleStandard Deviation 11.771
FBT w/Adolescent-focused Cognitive Remediation TherapyChange in Self-Reported Shifting - BRIEFAdolescent - T554.87 score on a scaleStandard Deviation 10.789
Comparison: This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRTp-value: 0.425generalized estimating equation
Comparison: This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRTp-value: 0.63generalized estimating equation
Comparison: This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRTp-value: 0.854generalized estimating equation
Primary

Dose of CRT

Number of sessions necessary in order to change cognitive flexibility. This is the number of sessions needed for change to occur in cognitive flexibility. It is only calculated for the participants who received CRT and who had a significant change in flexibility above what was observed in FBT.

Time frame: 6 months of treatment

Population: As parents did not hit a-priori milestones, we only calculated the number (count) of sessions needed for adolescents to have measurable improvement in cognitive flexibility.

ArmMeasureValue (NUMBER)
Family Based Treatment (FBT)Dose of CRT0 Number of sessions
FBT w/Adolescent-focused Cognitive Remediation TherapyDose of CRT8 Number of sessions

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026