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
  Purpose
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 Intervention
Psychosis
Behavioral: Family Cognitive Adaptation Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Family CAT (Cognitive Adaptation Training Manual): A Test of Effectiveness

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Multnomah Community Ability Scale (MCAS) [ Time Frame: 4 months following baseline assessment ] [ Designated as safety issue: No ]
    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:
  • Brief Adherence Rating Scale (BARS) [ Time Frame: 4 months following baseline assessment ] [ Designated as safety issue: No ]
    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.

  • Satisfaction With Life Scale [ Time Frame: 4 months following baseline assessment ] [ Designated as safety issue: No ]
    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.

  • Involvement Evaluation Questionnaire (IES) [ Time Frame: 4 months following baseline assessment ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: January 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768000

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

Additional Information:
Publications:

Responsible Party: Sean Kidd, Independent Clinician Scientist and Head Psychology Service, 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
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Centre for Addiction and Mental Health:
Psychosis
Psychosis NOS
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder

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

ClinicalTrials.gov processed this record on July 27, 2016