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The Family Cognitive Adaptation Training Manual: A Test of Effectiveness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sean Kidd, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01768000
First received: January 9, 2013
Last updated: February 1, 2016
Last verified: February 2016
Results First Received: September 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Psychosis
Intervention: Behavioral: Family Cognitive Adaptation Training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited between March 2013 and February 2014 in Ontario, Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 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.

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.
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 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.

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.

Participant Flow:   Overall Study
    Family Cognitive Adaptation Training - Caregivers     Control Group - Caregivers     Family Cognitive Adaptation Training - Family Members     Control Group - Family Members  
STARTED     10     10     10     10  
COMPLETED     9     8     9     8  
NOT COMPLETED     1     2     1     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Analysis includes all participants recruited into the study that completed the entire baseline assessment.

Reporting Groups
  Description
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.

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.

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.
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.
Total Total of all reporting groups

Baseline Measures
    Family Cognitive Adaptation Training - Family Members     Family Cognitive Adaptation Training - Caregivers     Control Group - Family Members     Control Group - Caregivers     Total  
Number of Participants  
[units: participants]
  10     10     9     9     38  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     10     9     9     8     36  
>=65 years     0     1     0     1     2  
Gender  
[units: participants]
         
Female     2     7     4     6     19  
Male     8     3     5     3     19  
Race/Ethnicity, Customized  
[units: 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  
[units: participants]
         
Canada     10     10     9     9     38  
Employment status  
[units: 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  
[units: 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]
[units: Participants]
         
Own/rent apartment or home     0     NA [1]   2     NA [1]   NA [2]
Supported housing     1     NA [1]   1     NA [1]   NA [2]
Live with family     9     NA [1]   6     NA [1]   NA [2]
[1] Housing data was collected only for the participant with psychosis and NOT the family member.
[2] Total not calculated because data are not available (NA) in one or more arms.



  Outcome Measures
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1.  Primary:   Multnomah Community Ability Scale (MCAS)   [ Time Frame: 4 months following baseline assessment ]

2.  Secondary:   Brief Adherence Rating Scale (BARS)   [ Time Frame: 4 months following baseline assessment ]

3.  Secondary:   Satisfaction With Life Scale   [ Time Frame: 4 months following baseline assessment ]

4.  Secondary:   Involvement Evaluation Questionnaire (IES)   [ Time Frame: 4 months following baseline assessment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: sean.kidd@camh.ca


Publications:


Responsible Party: Sean Kidd, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01768000     History of Changes
Other Study ID Numbers: 173/2012
Study First Received: January 9, 2013
Results First Received: September 22, 2015
Last Updated: February 1, 2016
Health Authority: Canada: Ethics Review Committee