Viewing Study NCT00000387



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Last Modification Date: 2024-10-26 @ 9:01 AM
Study NCT ID: NCT00000387
Status: COMPLETED
Last Update Posted: 2007-12-28
First Post: 1999-11-02

Brief Title: Self-Management Therapy for Youth With Schizophrenia
Sponsor: National Institute of Mental Health NIMH
Organization: National Institute of Mental Health NIMH

Study Overview

Official Title: Self-Management Therapy for Youth With Schizophrenia
Status: COMPLETED
Status Verified Date: 2007-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FamCent
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 interventions 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 7-12 months The effects of the intervention on the patient and hisher 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 heshe

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 thinkingcognitive 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-Kogans self-management nursing model Kanfers self-regulation theory and Libermans 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 adolescents 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 7-12 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DSIR CT-S None None None