NCT00000387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

Enrollment Period

6.8 years

First QC Date

November 2, 1999

Last Update Submit

December 26, 2007

Conditions

Keywords

AdolescenceFamilyFemaleHumanMaleSchizophreniaSelf CareCommunity Health Services

Outcome Measures

Primary Outcomes (1)

  • Increase in CAFAS level of functioning for all adolescents.

    Over the course of 14 months

Secondary Outcomes (1)

  • Increase in family functioning for families in the treatment group according to the designated family respondent.

    Over the course of 14 months

Study Arms (2)

A,1,III

EXPERIMENTAL

Behavioral intervention - Self management therapy

Behavioral: Self-management therapy

A,2,III

ACTIVE COMPARATOR

Regular treatment

Behavioral: Self-management therapy

Interventions

Behavioral

A,1,IIIA,2,III

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Karen G. Schepp, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

April 1, 1998

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations