Overview

This trial is active, not recruiting.

Condition emotion regulation, verbal aggression, physical aggression, irritability, anger
Treatments dbt for children, supportive-educational therapy
Phase phase 1/phase 2
Sponsor Weill Medical College of Cornell University
Collaborator Green Chimneys Residential Treatment Center, Brewster, NY
Start date April 2011
End date August 2015
Trial size 47 participants
Trial identifier NCT01547052, 1012007764

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).

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.

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dialectical Behavior Therapy adapted for children
dbt for children Dialectical Behavior Therapy adapted 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
(Active Comparator)
Enhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training
supportive-educational therapy Enhansed TAU
weekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions.

Primary Outcomes

Measure
Attendance Form
time frame: post-treatment at 30 weeks

Secondary Outcomes

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

Eligibility Criteria

Male participants from 6 years up to 12 years old.

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.

Additional Information

Official title Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation
Principal investigator Francheska Perepletchikova, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.