The Family Cognitive Adaptation Training Manual: A Test of Effectiveness

This study is ongoing, but not recruiting participants.
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: July 11, 2014
Last verified: July 2014
  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 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.


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.

  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
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.

  Hide Detailed Description

Detailed Description:

Efforts to address the cognitive impacts of schizophrenia can be broadly defined as falling into either compensatory or restorative categories. Restorative interventions, such as cognitive remediation, have shown promise in reducing cognitive deficits and improving functional outcomes (McGurk et al., 2007). In contrast, compensatory approaches such as Cognitive Adaptation Training work around cognitive deficits by changing the client's natural environment to support improved functioning. These compensatory strategies serve to bypass cognitive deficits and negative symptoms by organizing belongings and creating reminders and environmental cues to support specific adaptive behaviors. An example includes the individual packaging of clothes to be worn by day, to simplify the process of choosing what to wear and decrease the likelihood of clients impulsively putting on too many clothes or otherwise dressing in a manner that is not a good fit for the climate or social settings (Draper et al., 2009; Maples & Velligan, 2008).

Cognitive Adaptation Training (CAT) is a manualized intervention that was developed to help individuals compensate for the cognitive deficits associated with schizophrenia. CAT interventions commence with a neuropsychological assessment of clients to determine the best profile of strategies to be implemented for the specific cognitive classification within which the person is placed. Interventions are based on two dimensions 1) level of executive functioning (as determined by scores on a set of neurocognitive tests) and 2) whether the behaviour of the individual is characterized more by apathy (poverty of speech and movement and difficulty initiating behaviours), disinhibition (distractibility and impulsivity) or a combination of the two. Clinicians then develop and implement an individualized set of strategies that address key domains such as hygiene, safety, dress, and medication. These strategies are then altered for strengths or weaknesses in the areas of attention, memory, and fine motor skills. For example, for someone with poor attention, the colour of signs can be changed regularly or florescent colours can be used to capture attention. For someone with memory problems (particularly those with good auditory attention) audiotapes can be used to sequence behaviour.

CAT interventions are established and maintained in the home during monthly to weekly visits from a CAT therapist/trainer with the intervention typically lasting 9 months in most of the trials that have taken place to date

Outcomes of randomized trials of CAT have been promising. Compared to control conditions, clients receiving CAT have lower levels of symptomatology, lower relapse rates, higher levels of adaptive functioning, better quality of life, and better medication adherence (Velligan et al., 2000; 2002; 2007; 2008a; 2008b). In general, CAT has been shown to be beneficial for individuals with schizophrenia who vary both in degree and type of functional impairment.

The support and involvement of family in the care of individuals with schizophrenia is both one of the most important contributors to wellness and recovery and is also, unfortunately, one of the least acknowledged components of the recovery process. A high proportion of persons with severe mental illness stay in touch with family and the involvement of family in care has been associated with better clinical outcomes, improved quality of life, and less use of hospitalization (e.g., Fischer et al., 2008). Despite evidence of the importance of family in the recovery process, the contribution of family is often not adequately appreciated by treatment providers, and contact with providers is often limited. Similarly under-developed are evidence-based tools to assist families in their efforts to support the recovery of their loved ones.

It is within this context that the development of a family member version of CAT is a very promising avenue to explore. While some elements of CAT require or are otherwise optimized by administration by a mental health professional (e.g., neuropsychological testing; targeting interventions based upon ongoing clinical evaluation), there are many standard components of CAT that can be readily implemented by a family member or other key support. Examples include CAT interventions such as visual reminders regarding medication, arranging cleaning supplies in the kitchen to reinforce cleaning routines, and assisting in the use of a calendar for scheduling. We have developed a tool that facilitates family members implementing CAT components that do not require professional administration.

The initial 'beta' version of Family CAT was developed in close collaboration between Dr. Velligan's team at the University of Texas, the group implementing CAT at the CAMH site led by Dr. Kidd, and CAMH Social Workers. This 'beta' version is currently in the process of having its content reviewed by 6 families to obtain feedback regarding how readily it can be understood. Based on this feedback, we will make edits and produce the final version to be used in the trial proposed in this protocol.

  Eligibility

Ages Eligible for Study:   16 Years and older
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
Last Updated: July 11, 2014
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 26, 2014