Clinical trial NCT01547052: Adapting Dialectical Behavior Therapy for Children in Residential Care
Official title: Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Aggression
Keywords: DBT, child, emotion regulation, behavior problems
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Green Chimneys Residential Treatment Center, Brewster, NY
First posted: 2012-03-07
Enrollment: 47
Sex: MALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Attendance Form
timeFrame: post-treatment at 30 weeks
Secondary outcomes:
measure: Balloon Analog Risk Task
timeFrame: pre-treatment, week 6, 12, 18, 24, 30 of treatment and at 3 and 6 months follow-up
measure: Mood and Feelings Questionnaire
timeFrame: pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
measure: Emotion Regulation Checklist
timeFrame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
measure: Children's Coping Strategies Checklist
timeFrame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
measure: Pleasure Scale for Children
timeFrame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
measure: Social Skills Rating Scale
timeFrame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
measure: Therapy Satisfaction Questionnaire
timeFrame: week 30
measure: Therapist Satisfaction Scale
timeFrame: week 30
measure: Milieu Staff Satisfaction Questionnaire
timeFrame: every 6 months
measure: Incident Report
timeFrame: pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
measure: Psychosocial Treatment Compliance Scale
timeFrame: week 30
measure: Child Behavior Checklist
timeFrame: at pre-treatment, 6, 12, 18, 24, 30 weeks of treatment, and at 3 and 6 months follow-up
measure: Difficulty with Emotion Regulation Scale
timeFrame: pre-treatment
Other outcomes:
Locations:
city: Brewster
country: United States
facility: Green Chimneys Residential Treatment Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Francheska Perepletchikova, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: