Self-Management Therapy for Youth With Schizophrenia (FamCent)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Self-management therapy
Self-management therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Adolescence, Family, Female, Human, Male, Schizophrenia, Self Care, Community Health Services
Eligibility Criteria
Inclusion Criteria: - Patients must have: Schizophrenia as diagnosed according to DSM-IV criteria when screened by a mental health professional using the K-SADS and the DISA.
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A,1,III
A,2,III
Arm Description
Behavioral intervention - Self management therapy
Regular treatment
Outcomes
Primary Outcome Measures
Increase in CAFAS level of functioning for all adolescents.
Secondary Outcome Measures
Increase in family functioning for families in the treatment group according to the designated family respondent.
Full Information
NCT ID
NCT00000387
First Posted
November 2, 1999
Last Updated
December 26, 2007
Sponsor
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00000387
Brief Title
Self-Management Therapy for Youth With Schizophrenia
Acronym
FamCent
Official Title
Self-Management Therapy for Youth With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. The study will test the intervention's effectiveness in improving the adolescents' behavior, thinking, mood, and use of substances such as drugs and alcohol. The study also will look at the effects of the patient on the family.
The intervention involves training in recognizing symptoms of schizophrenia and in stress management, problem-solving, and social skills. Parents and siblings are included to gain knowledge and skills to support the adolescents.
The Self-Management Therapy intervention is administered in small multiple-family groups in 12 sessions over 7-1/2 months. The effects of the intervention on the patient and his/her family are assessed prior to treatment, after 6 sessions, after 12 sessions, and in a follow-up visit 6 months after completion of sessions.
A child may be eligible for this study if he/she:
Is 15 to 19 years old and has been diagnosed with schizophrenia.
Detailed Description
To test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. The primary aim is to test its effectiveness in improving the adolescents' level of functioning in role performance, thinking/cognitive processing, behavior towards others, mood, and use of substances. The second aim is to assess the impact of the intervention on family functioning. The third aim is to describe the relationships among the process variables of the intervention.
Nakagawa-Kogan's self-management nursing model, Kanfer's self-regulation theory, and Liberman's theory of stress and vulnerability provide the theoretical basis for the self-management intervention developed specifically for a population with deficits in cognitive processing. The intervention involves training in symptom awareness, stress management skills, problem-solving, and social skills. Parents and siblings are included to gain knowledge and skills to support the adolescents.
The adolescent's level of functioning is assessed using the Child and Adolescent Functional Assessment Scale, the Birchwood Early Signs & Symptoms Scale for schizophrenia, and the DISA. Family Functioning is assessed by computing a Composite Family Functioning Index using weighted scores from the FACES II, Family Apgar, Family Empowerment, and Family Social Support scales. One parent is designated by the family to be the family respondent on the scales. The adolescents are referred to the study by mental health professionals. The intervention is administered in small multiple-family groups in 12 sessions over 7-1/2 months. Data are collected at 4 points in time: at baseline, after 6 intensive sessions, after 6 monthly reinforcement sessions, and 6 months post-intervention. ANCOVA is used to test the study hypotheses. Multivariate relationships are examined among the process variables of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Adolescence, Family, Female, Human, Male, Schizophrenia, Self Care, Community Health Services
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A,1,III
Arm Type
Experimental
Arm Description
Behavioral intervention - Self management therapy
Arm Title
A,2,III
Arm Type
Active Comparator
Arm Description
Regular treatment
Intervention Type
Behavioral
Intervention Name(s)
Self-management therapy
Intervention Description
Behavioral
Intervention Type
Behavioral
Intervention Name(s)
Self-management therapy
Primary Outcome Measure Information:
Title
Increase in CAFAS level of functioning for all adolescents.
Time Frame
Over the course of 14 months
Secondary Outcome Measure Information:
Title
Increase in family functioning for families in the treatment group according to the designated family respondent.
Time Frame
Over the course of 14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-
Patients must have:
Schizophrenia as diagnosed according to DSM-IV criteria when screened by a mental health professional using the K-SADS and the DISA.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen G. Schepp, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Self-Management Therapy for Youth With Schizophrenia
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