Adapting Dialectical Behavior Therapy for Children in Residential Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Childhood Aggression

Intervention / Treatment
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* Behavioral: DBT for children
* Behavioral: Enhanced Supportive-Educational therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DBT, child, emotion regulation, behavior problems