Adapting Dialectical Behavior Therapy for Children in Residential Care (DBT-C)
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|ClinicalTrials.gov Identifier: NCT01547052|
Recruitment Status : Unknown
Verified May 2016 by Francheska Perepletchikova, Weill Medical College of Cornell University.
Recruitment status was: Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : May 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Emotion Regulation, Verbal Aggression, Physical Aggression, Irritability, Anger||Behavioral: DBT for children Behavioral: Supportive-Educational therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||September 2016|
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 Name: Dialectical Behavior Therapy adapted for Children
Active Comparator: Enhansed TAU
Enhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training
Behavioral: Supportive-Educational therapy
weekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions.
Other Name: Enhansed TAU
- Attendance Form [ Time Frame: post-treatment at 30 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547052
|United States, New York|
|Green Chimneys Residential Treatment Center|
|Brewster, New York, United States, 10509-0719|
|Principal Investigator:||Francheska Perepletchikova, Ph.D.||Weill Medical College of Cornell University|