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The Family Cognitive Adaptation Training Manual: A Test of Effectiveness

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ClinicalTrials.gov Identifier: NCT01768000
Recruitment Status : Completed
First Posted : January 15, 2013
Results First Posted : March 1, 2016
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Sean Kidd, Centre for Addiction and Mental Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psychosis
Intervention Behavioral: Family Cognitive Adaptation Training
Enrollment 40
Recruitment Details Recruited between March 2013 and February 2014 in Ontario, Canada.
Pre-assignment Details  
Arm/Group Title Family Cognitive Adaptation Training - Caregivers Control Group - Caregivers Family Cognitive Adaptation Training - Family Members Control Group - Family Members
Hide Arm/Group Description

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.
Period Title: Overall Study
Started 10 10 10 10
Completed 9 8 9 8
Not Completed 1 2 1 2
Arm/Group Title Family Cognitive Adaptation Training - Family Members Family Cognitive Adaptation Training - Caregivers Control Group - Family Members Control Group - Caregivers Total
Hide Arm/Group Description

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.

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.

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. 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. Total of all reporting groups
Overall Number of Baseline Participants 10 10 9 9 38
Hide Baseline Analysis Population Description
Baseline Analysis includes all participants recruited into the study that completed the entire baseline assessment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 9 participants 9 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
9
  90.0%
9
 100.0%
8
  88.9%
36
  94.7%
>=65 years
0
   0.0%
1
  10.0%
0
   0.0%
1
  11.1%
2
   5.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 9 participants 9 participants 38 participants
Female
2
  20.0%
7
  70.0%
4
  44.4%
6
  66.7%
19
  50.0%
Male
8
  80.0%
3
  30.0%
5
  55.6%
3
  33.3%
19
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 9 participants 9 participants 38 participants
Asian East 1 1 0 0 2
Asian South 1 3 1 0 5
Asian South East 1 0 0 0 1
Black Canadian 1 0 1 1 3
Latin American 0 1 0 0 1
White Canadian 5 5 5 3 18
White European 0 0 1 3 4
Other 0 0 0 1 1
Asian (not specified) 0 0 1 1 2
Not specified 1 0 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 10 participants 10 participants 9 participants 9 participants 38 participants
10 10 9 9 38
Employment status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 9 participants 9 participants 38 participants
Full-time 1 4 1 4 10
Part-time 1 2 1 3 7
In school 3 0 1 0 4
Unemployed 5 1 5 1 12
Retired 0 0 1 0 1
Contract work 0 3 0 0 3
Not specified 0 0 0 1 1
Level of education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 9 participants 9 participants 38 participants
Completion of graduate school 0 2 0 2 4
Completion of undergraduate university/college 0 5 2 4 11
Partial undergraduate university/college 7 2 5 0 14
Completion of high school 1 1 1 2 5
Partial high school 1 0 1 0 2
Not specified 1 0 0 1 2
Housing   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 9 participants 9 participants 38 participants
Own/rent apartment or home 0 NA [2]  2 NA [2]  NA [3] 
Supported housing 1 NA [2]  1 NA [2]  NA [3] 
Live with family 9 NA [2]  6 NA [2]  NA [3] 
[1]
Measure Description: Housing data was collected only for the participant with psychosis and NOT the family member.
[2]
Housing data was collected only for the participant with psychosis and NOT the family member.
[3]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title Multnomah Community Ability Scale (MCAS)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Family Cognitive Adaptation Training - Caregivers Control Group - Caregivers Family Cognitive Adaptation Training - Family Members Control Group - Family Members
Hide Arm/Group Description:

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.
Overall Number of Participants Analyzed 9 9 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total 67.78  (5.70) 74.63  (5.45) 70.00  (5.10) 74.38  (5.15)
Health 21.67  (2.34) 22.13  (2.36) 21.56  (1.88) 21.50  (1.93)
Adaptation 10.89  (2.57) 13.25  (1.67) 11.78  (1.92) 13.00  (1.69)
Social Skills 17.44  (3.17) 20.63  (2.50) 18.33  (3.87) 20.75  (2.71)
Behaviour 17.78  (1.72) 18.63  (1.77) 18.33  (1.80) 19.13  (1.36)
2.Secondary Outcome
Title Brief Adherence Rating Scale (BARS)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Family Cognitive Adaptation Training - Caregivers Control Group - Caregivers Family Cognitive Adaptation Training - Family Members Control Group - Family Members
Hide Arm/Group Description:

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.
Overall Number of Participants Analyzed 9 9 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
77.22  (35.98) 87.50  (35.36) 59.33  (44.03) 88.75  (31.82)
3.Secondary Outcome
Title Satisfaction With Life Scale
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Family Cognitive Adaptation Training - Family Members Control Group - Family Members
Hide Arm/Group Description:

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Social Relationships 2.06  (0.92) 2.18  (0.73)
Employment/Work 1.63  (1.16) 2.17  (0.41)
Social & Present Life 2.00  (0.99) 2.29  (0.76)
Living Situation 3.11  (0.49) 3.00  (0.66)
4.Secondary Outcome
Title Involvement Evaluation Questionnaire (IES)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Family Cognitive Adaptation Training - Caregivers Control Group - Caregivers
Hide Arm/Group Description:

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total 57.72  (9.66) 49.25  (11.15)
Tension 15.50  (4.27) 14.13  (2.85)
Supervision 8.22  (2.05) 7.50  (1.07)
Worrying 17.89  (4.31) 15.25  (4.40)
Urging 20.56  (7.13) 16.38  (5.66)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Family Cognitive Adaptation Training - Caregivers Control Group - Caregivers Family Cognitive Adaptation Training - Family Members Control Group - Family Members
Hide Arm/Group Description

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.

Participants in this group will receive the Family CAT manual and DVD.

Family 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.

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.
All-Cause Mortality
Family Cognitive Adaptation Training - Caregivers Control Group - Caregivers Family Cognitive Adaptation Training - Family Members Control Group - Family Members
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Family Cognitive Adaptation Training - Caregivers Control Group - Caregivers Family Cognitive Adaptation Training - Family Members Control Group - Family Members
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Family Cognitive Adaptation Training - Caregivers Control Group - Caregivers Family Cognitive Adaptation Training - Family Members Control Group - Family Members
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sean Kidd
Organization: Centre for Addiction and Mental Health
Phone: 416-535-8501 ext 36295
Publications:
Responsible Party: Sean Kidd, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01768000     History of Changes
Other Study ID Numbers: 173/2012
First Submitted: January 9, 2013
First Posted: January 15, 2013
Results First Submitted: September 22, 2015
Results First Posted: March 1, 2016
Last Update Posted: March 1, 2016