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Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services

Adaptation and Implementation of an ASD Executive Functioning Intervention in Children's Mental Health Services

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04295512
Enrollment
75
Registered
2020-03-04
Start date
2021-07-15
Completion date
2023-05-31
Last updated
2025-02-27

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

Conditions

Autism Spectrum Disorder, Executive Dysfunction, Mental Health Disorder

Brief summary

The purpose of this project is to conduct a feasibility test of an ASD executive functioning intervention adapted for mental health settings, including examining the effectiveness and process of implementing this adapted intervention in community mental health programs.

Detailed description

This project will examine the implementation and effectiveness of an ASD executive functioning intervention, entitled Unstuck and On Target, adapted for use in community mental health clinics. Minimizing the impact of executive functioning deficits in youth has broad public health implications, including improving the effectiveness of mental health services for youth such as those with autism spectrum disorders (ASD) and attention-deficit/hyperactivity disorder (ADHD). Improved executive functioning also has the potential for improvement in real-world functioning, including daily living skills, mental health, and educational outcomes. Although Unstuck and On Target is an established evidence-based intervention, the effectiveness of this intervention in mental health settings has not been established. Therefore, the primary aim is to collect data on implementation outcomes of the adapted intervention, including feasibility, utility, and therapist fidelity, in mental health settings. The secondary aim is to collect data on the preliminary effectiveness of Unstuck and On Target adapted for mental health settings. This study has the potential to make a significant impact by building local capacity to serve school-age children with executive functioning deficits in routine service settings, and advancing the science on the effectiveness of an established evidence-based practice (Unstuck and On Target) for specific services settings. It will also produce generalizable knowledge about implementation that can be applied for this population/setting.

Interventions

Unstuck and on Target is a cognitive-behavioral treatment that directly addresses executive functioning and self-regulation deficits in ASD and ADHD. Unstuck and on Target is the first contextually-based executive functioning treatment that targets flexibility, goal-setting and planning through a cognitive behavioral program centered on self-regulatory scripts that are consistently modeled and reinforced. Unstuck and on Target will be adapted for use in mental health service settings. Mental health therapists will be trained in Unstuck and on Target and deliver to youth and caregivers.

Sponsors

Rady Children's Hospital, San Diego
CollaboratorOTHER
San Diego State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
No

Inclusion criteria

for Therapists: 1. Employed as staff or a trainee at participating clinic (publicly-funded mental health program) 2. Employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months). 3. Has an eligible client on current caseload (see below). Inclusion Criteria for Child Participants 1. Child age 5-13 years. 2. Has a current ASD diagnosis on record. 3. English or Spanish speaking.

Exclusion criteria

for Child/ Parent Participants 1. Child does not present with executive functioning deficits. 2. Child does not meet criteria for ASD via case record, on the Autism Diagnostic Observation Scale or exhibit other clinical indicators of ASD

Design outcomes

Primary

MeasureTime frameDescription
Child Behavior ChecklistAt baseline and 6 months post-implementation.Child Behavior Checklist (CBCL) is a parent-report measure of child problem behavior. The CBCL is divided into three broadband scales (Internalizing, Externalizing, and Total Problem Scores) and several associate subscale scores. For this study, only the broadband scales were utilized for analyses. Scores are represented as T-scores with a population mean of 50 with standard deviation of 10 and ranges from 30 (minimum) to 95 (maximum. Higher scores reflect more mental health symptoms. The values reported below represent the mean change in the T-scores from the Total, Internalizing, and Externalizing T-Scores from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in symptoms (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole.
Acceptability of Intervention Measure6 months after starting implementationThe Acceptability of Intervention Measure (AIM) measure includes four items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher acceptability. This measure were designed to assess mental health providers' perceptions regarding acceptability of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.
Intervention Appropriateness Measure6 months after starting implementationThe Intervention Appropriateness Measure (IAM) measure includes four items assessing the appropriateness of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher appropriateness. This measure was designed to assess mental health providers' perceptions regarding appropriateness of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.
Feasibility of Intervention Measure6 months after starting implementationThe Feasibility of Intervention Measure (FIM) measure includes 4 items assessing the feasibility of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher feasibility. This measure was designed to assess mental health providers' perceptions regarding feasibility of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.
Average of Provider Fidelity Throughout Implementation PeriodA single, averaged value of all fidelity scores has been calculated. Average fidelity represents scores over the course of 6 months of therapist implementation. Table rows represent different aspects of fidelity that were scored.Provider adherence or fidelity to the Unstuck and On Target intervention will be measured through observational coding of provider in-session behaviors using the fidelity measure developed as part of the Unstuck and On Target intervention. Observers rate the provider's use of Unstuck and On Target on 9 components, using a 5-point (1 to 5) Likert scale, with higher scores indicating higher fidelity. For this report, a single, averaged value of all fidelity scores has been calculated per component.

Secondary

MeasureTime frameDescription
Eyberg Child Behavior InventoryAt baseline and 6 months post-implementation.The Eyberg Child Behavior Inventory is a 36 item questionnaire of child behavior. Caregivers of participating youth completed the questionnaire to assess their perceptions of their child's disruptive behaviors. The Eyberg Child Behavior Inventory Intensity Scale score measures the frequency of a child's behavioral problems and ranges from 36 (minimum value) to 352 (maximum). A score of 127 or higher is considered to be in the clinical range. The values reported below represent the mean change in the average T-score from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in problem behaviors (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole.

Other

MeasureTime frameDescription
Executive Functioning Challenge TaskAt baseline and 6 months post-implementation.The Executive Functioning Challenge Task deliberately tests a child's ability to utilize key executive functions like planning and flexibility by presenting scenarios that reveal potential areas of difficulty in their executive functioning skills. The test yields Flexibility and Planning raw scores with a minimum of 0 and maximum of 8. Higher scores indicate greater impairment in executive functioning. A total executive functioning raw score is also calculated as the sum of planning and flexibility scores. Values below represent the change in average raw scores from baseline to post-intervention for participating children. Negative scores represent an overall decrease in executive functioning impairment (better outcome) while positive scores representing an increase in executive functioning impairment (worse outcome) from baseline to post when looking at the condition groups as a whole.
Behavior Rating Inventory of Executive Function Second EditionAt baseline and 6 months post-implementation.The Behavior Rating Inventory of Executive Function- Second Edition is a 63-item rating scale completed by caregivers to assess executive function impairment in children. T scores have a population mean of 50 and standard deviation of 10, with a minimum score of 30 and maximum score of 95. Scales assessed included the Behavioral Regulation Index, Emotion Regulation Index and Cognitive Regulation Index, together forming an overall composite score, the Global Executive Composite. Values below represent the change in T-scores scores from baseline to post-intervention for participating children. T scores at or above 70 are considered clinically significant. Scores represent the change in T scores from baseline to post. Negative values represent decrease in impairment (better outcome) while positive scores representing an increase in impairment (worse outcome) from baseline to post when looking at the condition groups as a whole.
Wechsler Abbreviated Scale of Intelligence Second Edition- Block Design SubscaleAt baseline and 6 months post-implementation.The Wechsler Abbreviated Scale of Intelligence Second Edition, is a brief measure of intelligence. We administered the Block Design subscale, a timed visual construction task that measures changes in nonverbal reasoning ability by assessing an individual's capacity to analyze and synthesize abstract visual stimuli, demonstrating visual-spatial skills, and coordinating visual perception with motor actions to replicate geometric patterns using colored blocks.The subtest is scored by converting the raw scores into scale scores using standardized norms. Scores range from 1 (minimum) to 19 (maximum) with an average of 10. Values below represent the change in subscale scaled scores from baseline to post-intervention for participating children. Negative values represent an overall decrease in nonverbal reasoning ability (worse outcome) while positive values represent and overall increase in nonverbal reasoning ability (better outcome).

Countries

United States

Participant flow

Pre-assignment details

Numbers pertaining to those who started and completed don't match the protocol number. Participant numbers in fact exceeded the numbers for protocol enrollment with the exception of Usual Care: Children. Reason for this inconsistency is due to child recruitment at the start of the COVID 19 pandemic.

Participants by arm

ArmCount
Usual Care: Therapists
Community therapists delivering routine care in a community health setting. Note: some therapists enrolled with more than one child.
11
Unstuck and On Target: Therapists
Community therapists trained in delivering Unstuck and On Target in a community health setting. Note: some therapists enrolled with more than one child.
16
Usual Care: Children
Children with suspected or diagnosed ASD receiving care with a participating therapist.
12
Unstuck and On Target: Children
Children with suspected or diagnosed ASD receiving care with a participating therapist.
20
Total59

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLack of family response to schedule assessment0002
Overall StudyTherapist did not refer eligible family7700

Baseline characteristics

CharacteristicUsual Care: TherapistsUnstuck and On Target: TherapistsUsual Care: ChildrenUnstuck and On Target: ChildrenTotal
Age, Continuous
Age
34.07 years
STANDARD_DEVIATION 8.1
35.69 years
STANDARD_DEVIATION 6.1
9.37 years
STANDARD_DEVIATION 2.37
9.43 years
STANDARD_DEVIATION 2.46
35.07 years
STANDARD_DEVIATION 3.2
Child-Baseline Measures
Child- Social Responsiveness Scale, Baseline T Scores
74.17 units on a scale
STANDARD_DEVIATION 12.1
74.50 units on a scale
STANDARD_DEVIATION 9.81
74.37 units on a scale
STANDARD_DEVIATION 10.54
Child-Baseline Measures
Child- Wechsler Abbreviated Scale of Intelligence 2nd Edition, Baseline Standard Scores
92.42 units on a scale
STANDARD_DEVIATION 13.42
83.63 units on a scale
STANDARD_DEVIATION 17.99
87.03 units on a scale
STANDARD_DEVIATION 16.71
Ethnicity (NIH/OMB)
Ethnicity
Hispanic or Latino
6 Participants6 Participants9 Participants16 Participants37 Participants
Ethnicity (NIH/OMB)
Ethnicity
Not Hispanic or Latino
4 Participants10 Participants3 Participants4 Participants21 Participants
Ethnicity (NIH/OMB)
Ethnicity
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Race
American Indian or Alaska Native
0 Participants1 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Race
Asian
2 Participants2 Participants3 Participants0 Participants7 Participants
Race (NIH/OMB)
Race
Black or African American
0 Participants1 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Race
More than one race
2 Participants2 Participants3 Participants7 Participants14 Participants
Race (NIH/OMB)
Race
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Race
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Race
White
6 Participants10 Participants6 Participants11 Participants33 Participants
Region of Enrollment
United States
11 Participants16 Participants12 Participants20 Participants59 Participants
Sex: Female, Male
Sex
Female
9 Participants14 Participants2 Participants8 Participants33 Participants
Sex: Female, Male
Sex
Male
1 Participants2 Participants10 Participants12 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 230 / 120 / 22
other
Total, other adverse events
0 / 180 / 230 / 120 / 22
serious
Total, serious adverse events
0 / 180 / 230 / 120 / 22

Outcome results

Primary

Acceptability of Intervention Measure

The Acceptability of Intervention Measure (AIM) measure includes four items assessing the acceptability of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher acceptability. This measure were designed to assess mental health providers' perceptions regarding acceptability of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

Time frame: 6 months after starting implementation

Population: Measure only administered to Therapist intervention (Unstuck and On Target) group

ArmMeasureValue (MEAN)Dispersion
Therapists- Unstuck and On TargetAcceptability of Intervention Measure4.58 score on a scaleStandard Deviation 0.46
Primary

Average of Provider Fidelity Throughout Implementation Period

Provider adherence or fidelity to the Unstuck and On Target intervention will be measured through observational coding of provider in-session behaviors using the fidelity measure developed as part of the Unstuck and On Target intervention. Observers rate the provider's use of Unstuck and On Target on 9 components, using a 5-point (1 to 5) Likert scale, with higher scores indicating higher fidelity. For this report, a single, averaged value of all fidelity scores has been calculated per component.

Time frame: A single, averaged value of all fidelity scores has been calculated. Average fidelity represents scores over the course of 6 months of therapist implementation. Table rows represent different aspects of fidelity that were scored.

Population: Community therapists randomized to either usual care or intervention condition working with youth clients with an autism spectrum disorder.

ArmMeasureGroupValue (MEAN)Dispersion
Therapists- Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of Vocabulary1.75 score on a scaleStandard Deviation 1
Therapists- Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodGoal, Why, Plan, Do, Check1.25 score on a scaleStandard Deviation 0.77
Therapists- Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of Visuals2.10 score on a scaleStandard Deviation 1.13
Therapists- Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodModels Skills (Flexibility, planning)2.47 score on a scaleStandard Deviation 0.78
Therapists- Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodContent Delivery1.44 score on a scaleStandard Deviation 0.84
Therapists- Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of More Positive Praise than Correction4.63 score on a scaleStandard Deviation 0.44
Therapists- Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of Handouts1.57 score on a scaleStandard Deviation 0.82
Therapists- Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of Parent Engagement Strategies3.27 score on a scaleStandard Deviation 1.37
Therapists- Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodHome Practice Review1.36 score on a scaleStandard Deviation 0.56
Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of Parent Engagement Strategies4.00 score on a scaleStandard Deviation 1.13
Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of Handouts4.70 score on a scaleStandard Deviation 0.76
Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodHome Practice Review3.26 score on a scaleStandard Deviation 1.42
Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodContent Delivery4.74 score on a scaleStandard Deviation 0.61
Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of Visuals4.64 score on a scaleStandard Deviation 0.66
Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of Vocabulary4.47 score on a scaleStandard Deviation 0.67
Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodGoal, Why, Plan, Do, Check4.18 score on a scaleStandard Deviation 1.05
Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodModels Skills (Flexibility, planning)3.95 score on a scaleStandard Deviation 0.79
Unstuck and On TargetAverage of Provider Fidelity Throughout Implementation PeriodUse of More Positive Praise than Correction4.79 score on a scaleStandard Deviation 0.57
Primary

Child Behavior Checklist

Child Behavior Checklist (CBCL) is a parent-report measure of child problem behavior. The CBCL is divided into three broadband scales (Internalizing, Externalizing, and Total Problem Scores) and several associate subscale scores. For this study, only the broadband scales were utilized for analyses. Scores are represented as T-scores with a population mean of 50 with standard deviation of 10 and ranges from 30 (minimum) to 95 (maximum. Higher scores reflect more mental health symptoms. The values reported below represent the mean change in the T-scores from the Total, Internalizing, and Externalizing T-Scores from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in symptoms (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole.

Time frame: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

ArmMeasureGroupValue (MEAN)Dispersion
Therapists- Unstuck and On TargetChild Behavior ChecklistChange in Total Problem Score-4.54 units on a scaleStandard Deviation 6.22
Therapists- Unstuck and On TargetChild Behavior ChecklistChange in Internalizing Behavior Score-2.64 units on a scaleStandard Deviation 6.38
Therapists- Unstuck and On TargetChild Behavior ChecklistChange in Externalizing Behavior Score-5.36 units on a scaleStandard Deviation 5.35
Unstuck and On TargetChild Behavior ChecklistChange in Total Problem Score-2.33 units on a scaleStandard Deviation 4.53
Unstuck and On TargetChild Behavior ChecklistChange in Internalizing Behavior Score-1.67 units on a scaleStandard Deviation 4.17
Unstuck and On TargetChild Behavior ChecklistChange in Externalizing Behavior Score-1.87 units on a scaleStandard Deviation 6.97
Primary

Feasibility of Intervention Measure

The Feasibility of Intervention Measure (FIM) measure includes 4 items assessing the feasibility of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher feasibility. This measure was designed to assess mental health providers' perceptions regarding feasibility of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

Time frame: 6 months after starting implementation

Population: Measure only administered to Therapist intervention (Unstuck and On Target) group

ArmMeasureValue (MEAN)Dispersion
Therapists- Unstuck and On TargetFeasibility of Intervention Measure4.5 score on a scaleStandard Deviation 0.61
Primary

Intervention Appropriateness Measure

The Intervention Appropriateness Measure (IAM) measure includes four items assessing the appropriateness of an intervention. Participants rate the intervention using a 5-point Likert scale (1- Completely Disagree to 5- Completely Agree), with a minimum score of 4 and maximum score of 20 and higher scores indicating higher appropriateness. This measure was designed to assess mental health providers' perceptions regarding appropriateness of an evidence-based intervention. This measure demonstrate good reliability and validity. Providers trained in Unstuck and On Target completed this measure. Scores are an overall mean score.

Time frame: 6 months after starting implementation

Population: Measure only administered to Therapist intervention (Unstuck and On Target) group

ArmMeasureValue (MEAN)Dispersion
Therapists- Unstuck and On TargetIntervention Appropriateness Measure4.62 score on a scaleStandard Deviation 0.47
Secondary

Eyberg Child Behavior Inventory

The Eyberg Child Behavior Inventory is a 36 item questionnaire of child behavior. Caregivers of participating youth completed the questionnaire to assess their perceptions of their child's disruptive behaviors. The Eyberg Child Behavior Inventory Intensity Scale score measures the frequency of a child's behavioral problems and ranges from 36 (minimum value) to 352 (maximum). A score of 127 or higher is considered to be in the clinical range. The values reported below represent the mean change in the average T-score from baseline to 6 months post intervention for each condition group. Negative values represent an overall decrease in problem behaviors (better outcome) while positive values representing an increase in problem behaviors (worse outcome) from baseline to post when looking at the condition groups as a whole.

Time frame: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

ArmMeasureValue (MEAN)Dispersion
Therapists- Unstuck and On TargetEyberg Child Behavior Inventory-7.09 units on a scaleStandard Deviation 8.47
Unstuck and On TargetEyberg Child Behavior Inventory1.85 units on a scaleStandard Deviation 9.53
Other Pre-specified

Behavior Rating Inventory of Executive Function Second Edition

The Behavior Rating Inventory of Executive Function- Second Edition is a 63-item rating scale completed by caregivers to assess executive function impairment in children. T scores have a population mean of 50 and standard deviation of 10, with a minimum score of 30 and maximum score of 95. Scales assessed included the Behavioral Regulation Index, Emotion Regulation Index and Cognitive Regulation Index, together forming an overall composite score, the Global Executive Composite. Values below represent the change in T-scores scores from baseline to post-intervention for participating children. T scores at or above 70 are considered clinically significant. Scores represent the change in T scores from baseline to post. Negative values represent decrease in impairment (better outcome) while positive scores representing an increase in impairment (worse outcome) from baseline to post when looking at the condition groups as a whole.

Time frame: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

ArmMeasureGroupValue (MEAN)Dispersion
Therapists- Unstuck and On TargetBehavior Rating Inventory of Executive Function Second EditionChange in Behavioral Regulation Index T-Score-2.82 units on a scaleStandard Deviation 8.94
Therapists- Unstuck and On TargetBehavior Rating Inventory of Executive Function Second EditionChange in Emotion Regulation Index T-Score-2.82 units on a scaleStandard Deviation 10.42
Therapists- Unstuck and On TargetBehavior Rating Inventory of Executive Function Second EditionChange in Cognitive Regulation Index T-Score-1.55 units on a scaleStandard Deviation 7.09
Therapists- Unstuck and On TargetBehavior Rating Inventory of Executive Function Second EditionChange in Global Executive Composite T-Score-2.82 units on a scaleStandard Deviation 7.43
Unstuck and On TargetBehavior Rating Inventory of Executive Function Second EditionChange in Global Executive Composite T-Score-2.46 units on a scaleStandard Deviation 6.12
Unstuck and On TargetBehavior Rating Inventory of Executive Function Second EditionChange in Behavioral Regulation Index T-Score-3.54 units on a scaleStandard Deviation 5.39
Unstuck and On TargetBehavior Rating Inventory of Executive Function Second EditionChange in Cognitive Regulation Index T-Score-2.62 units on a scaleStandard Deviation 7.68
Unstuck and On TargetBehavior Rating Inventory of Executive Function Second EditionChange in Emotion Regulation Index T-Score-0.31 units on a scaleStandard Deviation 6.96
Other Pre-specified

Executive Functioning Challenge Task

The Executive Functioning Challenge Task deliberately tests a child's ability to utilize key executive functions like planning and flexibility by presenting scenarios that reveal potential areas of difficulty in their executive functioning skills. The test yields Flexibility and Planning raw scores with a minimum of 0 and maximum of 8. Higher scores indicate greater impairment in executive functioning. A total executive functioning raw score is also calculated as the sum of planning and flexibility scores. Values below represent the change in average raw scores from baseline to post-intervention for participating children. Negative scores represent an overall decrease in executive functioning impairment (better outcome) while positive scores representing an increase in executive functioning impairment (worse outcome) from baseline to post when looking at the condition groups as a whole.

Time frame: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

ArmMeasureGroupValue (MEAN)Dispersion
Therapists- Unstuck and On TargetExecutive Functioning Challenge TaskChange in Planning Score-0.09 units on a scaleStandard Deviation 1.81
Therapists- Unstuck and On TargetExecutive Functioning Challenge TaskChange in Flexibility Score-.82 units on a scaleStandard Deviation 2.93
Therapists- Unstuck and On TargetExecutive Functioning Challenge TaskChange in Executive Functioning Total Score-.91 units on a scaleStandard Deviation 4.01
Unstuck and On TargetExecutive Functioning Challenge TaskChange in Planning Score-2.21 units on a scaleStandard Deviation 1.97
Unstuck and On TargetExecutive Functioning Challenge TaskChange in Flexibility Score-0.79 units on a scaleStandard Deviation 1.63
Unstuck and On TargetExecutive Functioning Challenge TaskChange in Executive Functioning Total Score-3.00 units on a scaleStandard Deviation 2.8
Other Pre-specified

Wechsler Abbreviated Scale of Intelligence Second Edition- Block Design Subscale

The Wechsler Abbreviated Scale of Intelligence Second Edition, is a brief measure of intelligence. We administered the Block Design subscale, a timed visual construction task that measures changes in nonverbal reasoning ability by assessing an individual's capacity to analyze and synthesize abstract visual stimuli, demonstrating visual-spatial skills, and coordinating visual perception with motor actions to replicate geometric patterns using colored blocks.The subtest is scored by converting the raw scores into scale scores using standardized norms. Scores range from 1 (minimum) to 19 (maximum) with an average of 10. Values below represent the change in subscale scaled scores from baseline to post-intervention for participating children. Negative values represent an overall decrease in nonverbal reasoning ability (worse outcome) while positive values represent and overall increase in nonverbal reasoning ability (better outcome).

Time frame: At baseline and 6 months post-implementation.

Population: Children with suspected or diagnosed ASD receiving care with a participating therapist.

ArmMeasureValue (MEAN)Dispersion
Therapists- Unstuck and On TargetWechsler Abbreviated Scale of Intelligence Second Edition- Block Design Subscale5.18 units on a scaleStandard Deviation 7.99
Unstuck and On TargetWechsler Abbreviated Scale of Intelligence Second Edition- Block Design Subscale.79 units on a scaleStandard Deviation 6.29

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026