Self-Management Therapy for Youth With Schizophrenia (FamCent)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00000387
First received: November 2, 1999
Last updated: December 26, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Behavioral: Self-management therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-Management Therapy for Youth With Schizophrenia

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Increase in CAFAS level of functioning for all adolescents. [ Time Frame: Over the course of 14 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Increase in family functioning for families in the treatment group according to the designated family respondent. [ Time Frame: Over the course of 14 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: April 1998
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A,1,III
Behavioral intervention - Self management therapy
Behavioral: Self-management therapy
Behavioral
Behavioral: Self-management therapy
Active Comparator: A,2,III
Regular treatment
Behavioral: Self-management therapy
Behavioral
Behavioral: Self-management therapy

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.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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: NCT00000387

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Investigators
Principal Investigator: Karen G. Schepp, PhD
  More Information

No publications provided

Responsible Party: Karen G. Schepp, NIMH
ClinicalTrials.gov Identifier: NCT00000387     History of Changes
Other Study ID Numbers: R01 MH56580, DSIR CT-S
Study First Received: November 2, 1999
Last Updated: December 26, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Adolescence
Family
Female
Human
Male
Schizophrenia
Self Care
Community Health Services

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

ClinicalTrials.gov processed this record on October 29, 2014