Adapting Dialectical Behavior Therapy for Children in Residential Care

Not Applicable

Completed

• Conditions: Childhood Aggression
• Interventions: Behavioral: DBT for children; Behavioral: Enhanced Supportive-Educational therapy

• Registration Number: NCT01547052
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60 children in the comparison condition).

II: Finalize therapist training manuals and educational materials to guide selection, training, and supervision of treatment providers.

Detailed Description

Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment attendance, treatment satisfaction, and any differences in these rates by groups.

Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly greater treatment satisfaction rating by subjects, as well as by therapists and milieu staff.

Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and externalizing symptoms.

Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer internalizing and externalizing symptoms.

Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation, risk taking, and social skills, and reducing depression.

Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have significantly greater improvement in adaptive coping skills, emotion regulation, risk taking and impulsivity and social skills, and reducing depressive symptoms.

Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents.

Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer critical incidents, including psychiatric hospitalization, emergency room visits, total number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual acting out, running away, stealing, police involvement, etc.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Primary Completion: 2015-08
• Study Completion: 2016-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 47

Inclusion Criteria

• age between 6 years 0 months and 12 years 11 months;
• male;
• in residential care at Green Chimneys;
• projected length of stay is at least 8 months.

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Exclusion Criteria

• pervasive developmental disorder;
• psychotic disorder;
• mental retardation; (all as per psychiatric evaluation at Green Chimneys);
• in care or custody of the Department of Social Services (DSS);
• caregivers do not speak English.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DBT for children	DBT for children	Dialectical Behavior Therapy adapted for children
Enhanced Supportive-Educational Therapy	Enhanced Supportive-Educational therapy	Enhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training

Primary Outcome Measures

Name	Time	Method
Attendance Form	post-treatment at 30 weeks

Secondary Outcome Measures

Name	Time	Method
Milieu Staff Satisfaction Questionnaire	every 6 months
Social Skills Rating Scale	pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Balloon Analog Risk Task	pre-treatment, week 6, 12, 18, 24, 30 of treatment and at 3 and 6 months follow-up
Mood and Feelings Questionnaire	pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
Children's Coping Strategies Checklist	pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Pleasure Scale for Children	pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Therapy Satisfaction Questionnaire	week 30
Therapist Satisfaction Scale	week 30
Emotion Regulation Checklist	pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Incident Report	pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
Psychosocial Treatment Compliance Scale	week 30
Child Behavior Checklist	at pre-treatment, 6, 12, 18, 24, 30 weeks of treatment, and at 3 and 6 months follow-up
Difficulty with Emotion Regulation Scale	pre-treatment

Trial Locations

Locations (1)

Green Chimneys Residential Treatment Center; 🇺🇸 Brewster, New York, United States