Adapting Dialectical Behavior Therapy for Children in Residential Care (DBT-C)

Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation

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.

Study Overview

• Status: Completed
• Conditions: Childhood Aggression
• Intervention / Treatment: Behavioral: DBT for children; Behavioral: Enhanced Supportive-Educational therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brewster, New York, United States, 10509-0719
      • Green Chimneys Residential Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DBT for children; Dialectical Behavior Therapy adapted for children	Behavioral: DBT for children; intervention consists of weekly individual 45 min. sessions, twice per week 60 min. group sessions, and every other week 90 min. sessions with parents; Other Names: Dialectical Behavior Therapy adapted for Children
Active Comparator: Enhanced Supportive-Educational Therapy; Enhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training	Behavioral: Enhanced Supportive-Educational therapy; weekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions.; Other Names: Enhansed TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Attendance Form	post-treatment at 30 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Emotion Regulation Checklist	pre-treatment, weeks 12, 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
Social Skills Rating Scale	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
Milieu Staff Satisfaction Questionnaire	every 6 months
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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Green Chimneys Residential Treatment Center, Brewster, NY
• Investigators: Principal Investigator: Francheska Perepletchikova, Ph.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: DBT, child, emotion regulation, behavior problems
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression
• Other Study ID Numbers: 1012007764

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No