The Family Cognitive Adaptation Training Manual: A Test of Effectiveness
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.
|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|
- 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 domains of functionality including interference with functioning, adjustment to living, social competence, and behavioral problems. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score and scores for each of the five domains listed above.
- 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.
- 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.
- 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.
- Demographics [ Time Frame: At baseline assessment ] [ Designated as safety issue: No ]Demographic profile for the individuals with schizophrenia and their family members will include age, ethnicity, gender, length of illness (for individual with schizophrenia), amount of family involvement in care, socioeconomic status, employment status, education, housing, history of hospitalization, and support networks including service providers.
- Number of admissions into psychiatric hospital [ Time Frame: 1 year ] [ Designated as safety issue: No ]Hospitalization will be tracked by self-report of the individual with schizophrenia and as corroborated by the participating family member(s).
- Use and Utility of Family CAT [ Time Frame: 4 months following baseline assessment ] [ Designated as safety issue: No ]Assessed through the frequency and type of CAT-oriented contacts, and semi-structured interviews with family members about what was or wasn't helpful.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01768000
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada|
|Principal Investigator:||Sean Kidd, Ph.D||Centre for Addiction and Mental Health|