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The Family Cognitive Adaptation Training Manual: A Test of Effectiveness

The Family CAT (Cognitive Adaptation Training Manual): A Test of Effectiveness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01768000
Enrollment
40
Registered
2013-01-15
Start date
2013-01-31
Completion date
2014-10-31
Last updated
2016-03-01

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

Conditions

Psychosis

Keywords

Psychosis, Psychosis NOS, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Brief summary

The purpose of this study is to examine the effectiveness of family cognitive adaptation training, including its impact on functioning and caregiver burden. Families that receive the manual will be compared with a control group of families that will not receive the manual. The larger goal is to add to the tools family members have access to better support their family members with schizophrenia.

Detailed description

Efforts to address the cognitive impacts of schizophrenia can be broadly defined as falling into either compensatory or restorative categories. Restorative interventions, such as cognitive remediation, have shown promise in reducing cognitive deficits and improving functional outcomes (McGurk et al., 2007). In contrast, compensatory approaches such as Cognitive Adaptation Training work around cognitive deficits by changing the client's natural environment to support improved functioning. These compensatory strategies serve to bypass cognitive deficits and negative symptoms by organizing belongings and creating reminders and environmental cues to support specific adaptive behaviors. An example includes the individual packaging of clothes to be worn by day, to simplify the process of choosing what to wear and decrease the likelihood of clients impulsively putting on too many clothes or otherwise dressing in a manner that is not a good fit for the climate or social settings (Draper et al., 2009; Maples & Velligan, 2008). Cognitive Adaptation Training (CAT) is a manualized intervention that was developed to help individuals compensate for the cognitive deficits associated with schizophrenia. CAT interventions commence with a neuropsychological assessment of clients to determine the best profile of strategies to be implemented for the specific cognitive classification within which the person is placed. Interventions are based on two dimensions 1) level of executive functioning (as determined by scores on a set of neurocognitive tests) and 2) whether the behaviour of the individual is characterized more by apathy (poverty of speech and movement and difficulty initiating behaviours), disinhibition (distractibility and impulsivity) or a combination of the two. Clinicians then develop and implement an individualized set of strategies that address key domains such as hygiene, safety, dress, and medication. These strategies are then altered for strengths or weaknesses in the areas of attention, memory, and fine motor skills. For example, for someone with poor attention, the colour of signs can be changed regularly or florescent colours can be used to capture attention. For someone with memory problems (particularly those with good auditory attention) audiotapes can be used to sequence behaviour. CAT interventions are established and maintained in the home during monthly to weekly visits from a CAT therapist/trainer with the intervention typically lasting 9 months in most of the trials that have taken place to date Outcomes of randomized trials of CAT have been promising. Compared to control conditions, clients receiving CAT have lower levels of symptomatology, lower relapse rates, higher levels of adaptive functioning, better quality of life, and better medication adherence (Velligan et al., 2000; 2002; 2007; 2008a; 2008b). In general, CAT has been shown to be beneficial for individuals with schizophrenia who vary both in degree and type of functional impairment. The support and involvement of family in the care of individuals with schizophrenia is both one of the most important contributors to wellness and recovery and is also, unfortunately, one of the least acknowledged components of the recovery process. A high proportion of persons with severe mental illness stay in touch with family and the involvement of family in care has been associated with better clinical outcomes, improved quality of life, and less use of hospitalization (e.g., Fischer et al., 2008). Despite evidence of the importance of family in the recovery process, the contribution of family is often not adequately appreciated by treatment providers, and contact with providers is often limited. Similarly under-developed are evidence-based tools to assist families in their efforts to support the recovery of their loved ones. It is within this context that the development of a family member version of CAT is a very promising avenue to explore. While some elements of CAT require or are otherwise optimized by administration by a mental health professional (e.g., neuropsychological testing; targeting interventions based upon ongoing clinical evaluation), there are many standard components of CAT that can be readily implemented by a family member or other key support. Examples include CAT interventions such as visual reminders regarding medication, arranging cleaning supplies in the kitchen to reinforce cleaning routines, and assisting in the use of a calendar for scheduling. We have developed a tool that facilitates family members implementing CAT components that do not require professional administration. The initial 'beta' version of Family CAT was developed in close collaboration between Dr. Velligan's team at the University of Texas, the group implementing CAT at the CAMH site led by Dr. Kidd, and CAMH Social Workers. This 'beta' version is currently in the process of having its content reviewed by 6 families to obtain feedback regarding how readily it can be understood. Based on this feedback, we will make edits and produce the final version to be used in the trial proposed in this protocol.

Interventions

BEHAVIORALFamily Cognitive Adaptation Training

Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* the key family member/support is actively involved in the support of the individual with schizophrenia and regularly visits them (i.e., once a week or more frequently) in their home environment * the individual being supported is identified (self-identified and identified by the family member) as having a primary diagnosis of schizophrenia * the individual with schizophrenia is not in crisis or experiencing other forms of instability (e.g., imminent loss of housing) per verbal report that would threaten the implementation of the manual strategies * proficiency in English

Exclusion criteria

\- none

Design outcomes

Primary

MeasureTime frameDescription
Multnomah Community Ability Scale (MCAS)4 months following baseline assessmentThe Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.

Secondary

MeasureTime frameDescription
Brief Adherence Rating Scale (BARS)4 months following baseline assessmentThe Brief Adherence Rating Scale (BARS; Byerly et al., 2008) is a 4-item, valid, reliable, sensitive, measure with which to obtain specific estimates of antipsychotic medication adherence of outpatients with schizophrenia. A total percentage score on a scale ranging from 0 to 100, with 0 indicating less adherence and 100 total adherence.
Satisfaction With Life Scale4 months following baseline assessment8 out of 18 items from the Satisfaction With Life Scale (Test et al., 2005) will measure the perceived quality of life of the individual with schizophrenia by tapping into global satisfaction in domains relevant to CAT (e.g., How satisfied are you with yourself on the whole? - 5 point scale, not at all - great deal). This scale is well-validated with a schizophrenia population and is being shortened as not all items are relevant to CAT nor expected to be sensitive to change in a 4 month period, and there is a need to abbreviate the battery to reduce the risk of fatigue in a lengthy phone interview. These 8 items comprise four domains of social relationships, employment/work, social and present life and living situation. A low score indicates less satisfaction in these domains and a higher score indicating greater satisfaction. Total scores can range from 8-40 and subscale scores range from 1-5.
Involvement Evaluation Questionnaire (IES)4 months following baseline assessmentThe 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000) measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.

Countries

Canada

Participant flow

Recruitment details

Recruited between March 2013 and February 2014 in Ontario, Canada.

Participants by arm

ArmCount
Family Cognitive Adaptation Training - Family Members
Participants in this group will receive the Family CAT manual and DVD. Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
10
Family Cognitive Adaptation Training - Caregivers
Participants in this group will receive the Family CAT manual and DVD. Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
10
Control Group - Family Members
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
9
Control Group - Caregivers
Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
9
Total38

Baseline characteristics

CharacteristicFamily Cognitive Adaptation Training - CaregiversFamily Cognitive Adaptation Training - Family MembersTotalControl Group - CaregiversControl Group - Family Members
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants0 Participants2 Participants1 Participants0 Participants
Age, Categorical
Between 18 and 65 years
9 Participants10 Participants36 Participants8 Participants9 Participants
Employment status
Contract work
3 participants0 participants3 participants0 participants0 participants
Employment status
Full-time
4 participants1 participants10 participants4 participants1 participants
Employment status
In school
0 participants3 participants4 participants0 participants1 participants
Employment status
Not specified
0 participants0 participants1 participants1 participants0 participants
Employment status
Part-time
2 participants1 participants7 participants3 participants1 participants
Employment status
Retired
0 participants0 participants1 participants0 participants1 participants
Employment status
Unemployed
1 participants5 participants12 participants1 participants5 participants
Housing
Live with family
NA Participants9 ParticipantsNA ParticipantsNA Participants6 Participants
Housing
Own/rent apartment or home
NA Participants0 ParticipantsNA ParticipantsNA Participants2 Participants
Housing
Supported housing
NA Participants1 ParticipantsNA ParticipantsNA Participants1 Participants
Level of education
Completion of graduate school
2 participants0 participants4 participants2 participants0 participants
Level of education
Completion of high school
1 participants1 participants5 participants2 participants1 participants
Level of education
Completion of undergraduate university/college
5 participants0 participants11 participants4 participants2 participants
Level of education
Not specified
0 participants1 participants2 participants1 participants0 participants
Level of education
Partial high school
0 participants1 participants2 participants0 participants1 participants
Level of education
Partial undergraduate university/college
2 participants7 participants14 participants0 participants5 participants
Race/Ethnicity, Customized
Asian East
1 participants1 participants2 participants0 participants0 participants
Race/Ethnicity, Customized
Asian (not specified)
0 participants0 participants2 participants1 participants1 participants
Race/Ethnicity, Customized
Asian South
3 participants1 participants5 participants0 participants1 participants
Race/Ethnicity, Customized
Asian South East
0 participants1 participants1 participants0 participants0 participants
Race/Ethnicity, Customized
Black Canadian
0 participants1 participants3 participants1 participants1 participants
Race/Ethnicity, Customized
Latin American
1 participants0 participants1 participants0 participants0 participants
Race/Ethnicity, Customized
Not specified
0 participants1 participants1 participants0 participants0 participants
Race/Ethnicity, Customized
Other
0 participants0 participants1 participants1 participants0 participants
Race/Ethnicity, Customized
White Canadian
5 participants5 participants18 participants3 participants5 participants
Race/Ethnicity, Customized
White European
0 participants0 participants4 participants3 participants1 participants
Region of Enrollment
Canada
10 participants10 participants38 participants9 participants9 participants
Sex: Female, Male
Female
7 Participants2 Participants19 Participants6 Participants4 Participants
Sex: Female, Male
Male
3 Participants8 Participants19 Participants3 Participants5 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
— / —— / —— / —— / —
other
Total, other adverse events
0 / 100 / 100 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 100 / 10

Outcome results

Primary

Multnomah Community Ability Scale (MCAS)

The Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.

Time frame: 4 months following baseline assessment

ArmMeasureGroupValue (MEAN)Dispersion
Family Cognitive Adaptation Training - CaregiversMultnomah Community Ability Scale (MCAS)Social Skills17.44 units on a scaleStandard Deviation 3.17
Family Cognitive Adaptation Training - CaregiversMultnomah Community Ability Scale (MCAS)Health21.67 units on a scaleStandard Deviation 2.34
Family Cognitive Adaptation Training - CaregiversMultnomah Community Ability Scale (MCAS)Behaviour17.78 units on a scaleStandard Deviation 1.72
Family Cognitive Adaptation Training - CaregiversMultnomah Community Ability Scale (MCAS)Adaptation10.89 units on a scaleStandard Deviation 2.57
Family Cognitive Adaptation Training - CaregiversMultnomah Community Ability Scale (MCAS)Total67.78 units on a scaleStandard Deviation 5.7
Control Group - CaregiversMultnomah Community Ability Scale (MCAS)Adaptation13.25 units on a scaleStandard Deviation 1.67
Control Group - CaregiversMultnomah Community Ability Scale (MCAS)Social Skills20.63 units on a scaleStandard Deviation 2.5
Control Group - CaregiversMultnomah Community Ability Scale (MCAS)Behaviour18.63 units on a scaleStandard Deviation 1.77
Control Group - CaregiversMultnomah Community Ability Scale (MCAS)Health22.13 units on a scaleStandard Deviation 2.36
Control Group - CaregiversMultnomah Community Ability Scale (MCAS)Total74.63 units on a scaleStandard Deviation 5.45
Family Cognitive Adaptation Training - Family MembersMultnomah Community Ability Scale (MCAS)Adaptation11.78 units on a scaleStandard Deviation 1.92
Family Cognitive Adaptation Training - Family MembersMultnomah Community Ability Scale (MCAS)Total70.00 units on a scaleStandard Deviation 5.1
Family Cognitive Adaptation Training - Family MembersMultnomah Community Ability Scale (MCAS)Health21.56 units on a scaleStandard Deviation 1.88
Family Cognitive Adaptation Training - Family MembersMultnomah Community Ability Scale (MCAS)Social Skills18.33 units on a scaleStandard Deviation 3.87
Family Cognitive Adaptation Training - Family MembersMultnomah Community Ability Scale (MCAS)Behaviour18.33 units on a scaleStandard Deviation 1.8
Control Group - Family MembersMultnomah Community Ability Scale (MCAS)Social Skills20.75 units on a scaleStandard Deviation 2.71
Control Group - Family MembersMultnomah Community Ability Scale (MCAS)Health21.50 units on a scaleStandard Deviation 1.93
Control Group - Family MembersMultnomah Community Ability Scale (MCAS)Total74.38 units on a scaleStandard Deviation 5.15
Control Group - Family MembersMultnomah Community Ability Scale (MCAS)Adaptation13.00 units on a scaleStandard Deviation 1.69
Control Group - Family MembersMultnomah Community Ability Scale (MCAS)Behaviour19.13 units on a scaleStandard Deviation 1.36
Secondary

Brief Adherence Rating Scale (BARS)

The Brief Adherence Rating Scale (BARS; Byerly et al., 2008) is a 4-item, valid, reliable, sensitive, measure with which to obtain specific estimates of antipsychotic medication adherence of outpatients with schizophrenia. A total percentage score on a scale ranging from 0 to 100, with 0 indicating less adherence and 100 total adherence.

Time frame: 4 months following baseline assessment

ArmMeasureValue (MEAN)Dispersion
Family Cognitive Adaptation Training - CaregiversBrief Adherence Rating Scale (BARS)77.22 units on a scaleStandard Deviation 35.98
Control Group - CaregiversBrief Adherence Rating Scale (BARS)87.50 units on a scaleStandard Deviation 35.36
Family Cognitive Adaptation Training - Family MembersBrief Adherence Rating Scale (BARS)59.33 units on a scaleStandard Deviation 44.03
Control Group - Family MembersBrief Adherence Rating Scale (BARS)88.75 units on a scaleStandard Deviation 31.82
Secondary

Involvement Evaluation Questionnaire (IES)

The 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000) measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.

Time frame: 4 months following baseline assessment

ArmMeasureGroupValue (MEAN)Dispersion
Family Cognitive Adaptation Training - CaregiversInvolvement Evaluation Questionnaire (IES)Tension15.50 units on a scaleStandard Deviation 4.27
Family Cognitive Adaptation Training - CaregiversInvolvement Evaluation Questionnaire (IES)Worrying17.89 units on a scaleStandard Deviation 4.31
Family Cognitive Adaptation Training - CaregiversInvolvement Evaluation Questionnaire (IES)Supervision8.22 units on a scaleStandard Deviation 2.05
Family Cognitive Adaptation Training - CaregiversInvolvement Evaluation Questionnaire (IES)Urging20.56 units on a scaleStandard Deviation 7.13
Family Cognitive Adaptation Training - CaregiversInvolvement Evaluation Questionnaire (IES)Total57.72 units on a scaleStandard Deviation 9.66
Control Group - CaregiversInvolvement Evaluation Questionnaire (IES)Urging16.38 units on a scaleStandard Deviation 5.66
Control Group - CaregiversInvolvement Evaluation Questionnaire (IES)Total49.25 units on a scaleStandard Deviation 11.15
Control Group - CaregiversInvolvement Evaluation Questionnaire (IES)Tension14.13 units on a scaleStandard Deviation 2.85
Control Group - CaregiversInvolvement Evaluation Questionnaire (IES)Supervision7.50 units on a scaleStandard Deviation 1.07
Control Group - CaregiversInvolvement Evaluation Questionnaire (IES)Worrying15.25 units on a scaleStandard Deviation 4.4
Secondary

Satisfaction With Life Scale

8 out of 18 items from the Satisfaction With Life Scale (Test et al., 2005) will measure the perceived quality of life of the individual with schizophrenia by tapping into global satisfaction in domains relevant to CAT (e.g., How satisfied are you with yourself on the whole? - 5 point scale, not at all - great deal). This scale is well-validated with a schizophrenia population and is being shortened as not all items are relevant to CAT nor expected to be sensitive to change in a 4 month period, and there is a need to abbreviate the battery to reduce the risk of fatigue in a lengthy phone interview. These 8 items comprise four domains of social relationships, employment/work, social and present life and living situation. A low score indicates less satisfaction in these domains and a higher score indicating greater satisfaction. Total scores can range from 8-40 and subscale scores range from 1-5.

Time frame: 4 months following baseline assessment

ArmMeasureGroupValue (MEAN)Dispersion
Family Cognitive Adaptation Training - CaregiversSatisfaction With Life ScaleSocial & Present Life2.00 units on a scaleStandard Deviation 0.99
Family Cognitive Adaptation Training - CaregiversSatisfaction With Life ScaleEmployment/Work1.63 units on a scaleStandard Deviation 1.16
Family Cognitive Adaptation Training - CaregiversSatisfaction With Life ScaleLiving Situation3.11 units on a scaleStandard Deviation 0.49
Family Cognitive Adaptation Training - CaregiversSatisfaction With Life ScaleSocial Relationships2.06 units on a scaleStandard Deviation 0.92
Control Group - CaregiversSatisfaction With Life ScaleLiving Situation3.00 units on a scaleStandard Deviation 0.66
Control Group - CaregiversSatisfaction With Life ScaleEmployment/Work2.17 units on a scaleStandard Deviation 0.41
Control Group - CaregiversSatisfaction With Life ScaleSocial & Present Life2.29 units on a scaleStandard Deviation 0.76
Control Group - CaregiversSatisfaction With Life ScaleSocial Relationships2.18 units on a scaleStandard Deviation 0.73

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026