Home | All trials

[RDF data]
Trial NCT00000387

Resource URI: http://static.linkedct.org/resource/trials/NCT00000387
PropertyValue
linkedct:acronym FamCent
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/32256>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/32270>
linkedct:brief_title Self-Management Therapy for Youth With Schizophrenia
linkedct:condition <http://static.linkedct.org/resource/condition/11790>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 19 Years
linkedct:eligibility_minimum_age 15 Years
linkedct:end_date January 2005
linkedct:enrollment 40 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:has_dmc No
linkedct:id NCT00000387
linkedct:intervention <http://static.linkedct.org/resource/intervention/32806>
rdfs:label Trial NCT00000387
linkedct:lastchanged_date December 26, 2007
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:location <http://static.linkedct.org/resource/location/220436>
linkedct:nct_id NCT00000387
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Self-Management Therapy for Youth With Schizophrenia
linkedct:org_study_id R01 MH56580
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/31612>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000387>
linkedct:phase Phase 3
linkedct:primary_completion_date January 2005
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/70674>
linkedct:secondary_id DSIR CT-S
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/57818>
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date April 1998
linkedct:study_design Treatment, Randomized, Open Label, Active Control, Parallel Assignment
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date December 2007