Adapting Dialectical Behavior Therapy for Children in Residential Care (DBT-C)
Primary Purpose
Childhood Aggression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DBT for children
Enhanced Supportive-Educational therapy
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Aggression focused on measuring DBT, child, emotion regulation, behavior problems
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.
Sites / Locations
- Green Chimneys Residential Treatment Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DBT for children
Enhanced Supportive-Educational Therapy
Arm Description
Dialectical Behavior Therapy adapted for children
Enhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training
Outcomes
Primary Outcome Measures
Attendance Form
Secondary Outcome Measures
Balloon Analog Risk Task
Mood and Feelings Questionnaire
Emotion Regulation Checklist
Children's Coping Strategies Checklist
Pleasure Scale for Children
Social Skills Rating Scale
Therapy Satisfaction Questionnaire
Therapist Satisfaction Scale
Milieu Staff Satisfaction Questionnaire
Incident Report
Psychosocial Treatment Compliance Scale
Child Behavior Checklist
Difficulty with Emotion Regulation Scale
Full Information
NCT ID
NCT01547052
First Posted
March 1, 2012
Last Updated
July 19, 2018
Sponsor
Weill Medical College of Cornell University
Collaborators
Green Chimneys Residential Treatment Center, Brewster, NY
1. Study Identification
Unique Protocol Identification Number
NCT01547052
Brief Title
Adapting Dialectical Behavior Therapy for Children in Residential Care
Acronym
DBT-C
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Green Chimneys Residential Treatment Center, Brewster, NY
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Aggression
Keywords
DBT, child, emotion regulation, behavior problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DBT for children
Arm Type
Experimental
Arm Description
Dialectical Behavior Therapy adapted for children
Arm Title
Enhanced Supportive-Educational Therapy
Arm Type
Active Comparator
Arm Description
Enhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training
Intervention Type
Behavioral
Intervention Name(s)
DBT for children
Other Intervention Name(s)
Dialectical Behavior Therapy adapted for Children
Intervention Description
intervention consists of weekly individual 45 min. sessions, twice per week 60 min. group sessions, and every other week 90 min. sessions with parents
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Supportive-Educational therapy
Other Intervention Name(s)
Enhansed TAU
Intervention Description
weekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions.
Primary Outcome Measure Information:
Title
Attendance Form
Time Frame
post-treatment at 30 weeks
Secondary Outcome Measure Information:
Title
Balloon Analog Risk Task
Time Frame
pre-treatment, week 6, 12, 18, 24, 30 of treatment and at 3 and 6 months follow-up
Title
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
Title
Emotion Regulation Checklist
Time Frame
pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Title
Children's Coping Strategies Checklist
Time Frame
pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Title
Pleasure Scale for Children
Time Frame
pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Title
Social Skills Rating Scale
Time Frame
pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Title
Therapy Satisfaction Questionnaire
Time Frame
week 30
Title
Therapist Satisfaction Scale
Time Frame
week 30
Title
Milieu Staff Satisfaction Questionnaire
Time Frame
every 6 months
Title
Incident Report
Time Frame
pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
Title
Psychosocial Treatment Compliance Scale
Time Frame
week 30
Title
Child Behavior Checklist
Time Frame
at pre-treatment, 6, 12, 18, 24, 30 weeks of treatment, and at 3 and 6 months follow-up
Title
Difficulty with Emotion Regulation Scale
Time Frame
pre-treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francheska Perepletchikova, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Green Chimneys Residential Treatment Center
City
Brewster
State/Province
New York
ZIP/Postal Code
10509-0719
Country
United States
12. IPD Sharing Statement
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Adapting Dialectical Behavior Therapy for Children in Residential Care
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