The Family Cognitive Adaptation Training Manual: A Test of Effectiveness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01768000
Recruitment Status : Completed
First Posted : January 15, 2013
Results First Posted : March 1, 2016
Last Update Posted : March 1, 2016
Information provided by (Responsible Party):
Sean Kidd, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Psychosis Behavioral: Family Cognitive Adaptation Training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Family CAT (Cognitive Adaptation Training Manual): A Test of Effectiveness
Study Start Date : January 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Family Cognitive Adaptation Training
Participants in this group will receive the Family CAT manual and DVD
Behavioral: 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.
Other Name: Family CAT

No Intervention: Control group
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.

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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01768000

Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Sponsors and Collaborators
Centre for Addiction and Mental Health
Principal Investigator: Sean Kidd, Ph.D Centre for Addiction and Mental Health

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sean Kidd, Independent Clinician Scientist and Head Psychology Service, Centre for Addiction and Mental Health Identifier: NCT01768000     History of Changes
Other Study ID Numbers: 173/2012
First Posted: January 15, 2013    Key Record Dates
Results First Posted: March 1, 2016
Last Update Posted: March 1, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sean Kidd, Centre for Addiction and Mental Health:
Psychosis NOS
Schizoaffective Disorder
Bipolar Disorder

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders