Expired Study
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Seattle, Washington 98195


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

R01 MH56580


NCT ID:

NCT00000387


Secondary ID:

DSIR CT-S


Study Acronym:

FamCent


Brief Title:

Self-Management Therapy for Youth With Schizophrenia


Official Title:

Self-Management Therapy for Youth With Schizophrenia


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

15 Years


Maximum Age:

19 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Mental Health (NIMH)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Karen G. Schepp, PhD
Principal Investigator

Study Dates

Start Date:April 1998
Completion Date:January 2005
Completion Type:Actual
Primary Completion Date:January 2005
Primary Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 26, 2007
First Received Date:November 2, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Increase in CAFAS level of functioning for all adolescents.
Time Frame:Over the course of 14 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Increase in family functioning for families in the treatment group according to the designated family respondent.
Time Frame:Over the course of 14 months
Safety Issues:True

Study Interventions

Intervention Type:Behavioral
Name:Self-management therapy
Description:Behavioral
Arm Name:A,1,III
Intervention Type:Behavioral
Name:Self-management therapy
Arm Name:A,1,III

Study Arms

Study Arm Type:Experimental
Arm Name:A,1,III
Description:Behavioral intervention - Self management therapy
Study Arm Type:Active Comparator
Arm Name:A,2,III
Description:Regular treatment

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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