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Adapting Dialectical Behavior Therapy for Children in Residential Care (DBT-C)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01547052
First Posted: March 7, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Green Chimneys Residential Treatment Center, Brewster, NY
Information provided by (Responsible Party):
Francheska Perepletchikova, Weill Medical College of Cornell University
  Purpose

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 Intervention Phase
Emotion Regulation, Verbal Aggression, Physical Aggression, Irritability, Anger Behavioral: DBT for children Behavioral: Supportive-Educational therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation

Further study details as provided by Francheska Perepletchikova, Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Attendance Form [ Time Frame: post-treatment at 30 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 47
Study Start Date: April 2011
Estimated Study Completion Date: September 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, New York
Green Chimneys Residential Treatment Center
Brewster, New York, United States, 10509-0719
Sponsors and Collaborators
Weill Medical College of Cornell University
Green Chimneys Residential Treatment Center, Brewster, NY
Investigators
Principal Investigator: Francheska Perepletchikova, Ph.D. Weill Medical College of Cornell University
  More Information

Responsible Party: Francheska Perepletchikova, Assistant Professor of Psychology in Psychiatry, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01547052     History of Changes
Other Study ID Numbers: 1012007764
First Submitted: March 1, 2012
First Posted: March 7, 2012
Last Update Posted: October 12, 2017
Last Verified: May 2016

Keywords provided by Francheska Perepletchikova, Weill Medical College of Cornell University:
DBT, child, emotion regulation, behavior problems, residential care

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms