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

This study is currently recruiting participants.
Verified May 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
Green Chimneys Residential Treatment Center, Brewster, NY
Information provided by (Responsible Party):
Francheska Perepletchikova, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01547052
First received: March 1, 2012
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  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
Internalizing and Externalizing Symptoms in Pediatric Population as Measures by Child Behavior Checklist
 Behavioral: Dialectical Behavior Therapy Adapted for children
Behavioral: Supportive-Educational therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Attendance Form [ Time Frame: post-treatment at 30 weeks ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Emotion Regulation Checklist [ Time Frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up ] [ Designated as safety issue: No ]
  • Children's Coping Strategies Checklist [ Time Frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up ] [ Designated as safety issue: No ]
  • Pleasure Scale for Children [ Time Frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up ] [ Designated as safety issue: No ]
  • Social Skills Rating Scale [ Time Frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up ] [ Designated as safety issue: No ]
  • Therapy Satisfaction Questionnaire [ Time Frame: week 30 ] [ Designated as safety issue: No ]
  • Therapist Satisfaction Scale [ Time Frame: week 30 ] [ Designated as safety issue: No ]
  • Milieu Staff Satisfaction Questionnaire [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Incident Report [ Time Frame: pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up ] [ Designated as safety issue: No ]
  • Psychosocial Treatment Compliance Scale [ Time Frame: week 30 ] [ Designated as safety issue: No ]
  • Child Behavior Checklist [ Time Frame: at pre-treatment, 6, 12, 18, 24, 30 weeks of treatment, and at 3 and 6 months follow-up ] [ Designated as safety issue: No ]
  • Difficulty with Emotion Regulation Scale [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dialectical Behavior Therapy Adapted for children Behavioral: Dialectical Behavior Therapy Adapted 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: DBT-C
Active Comparator: Enhansed Treatment-as-Usual
supportive-educational therapy
 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

Ages Eligible for Study:   6 Years to 12 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547052

Contacts
Contact: Steven Klee, Ph.D. (845) 279-2995 sklee@greenchimneys.org

Locations
United States, New York
Green Chimneys Residential Treatment Center Recruiting
Brewster, New York, United States, 10509-0719
Contact: Steven Klee, Ph.D.     845-279-2995     sklee@greenchimneys.org    
Contact: Jay Davidowitz     (845) 279-2995     jdavidowitz@greenchimnyes.org    
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

No publications provided

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
Study First Received: March 1, 2012
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Dialectical Behavior Therapy, child, emotion regulation, behavior problems, residential care

ClinicalTrials.gov processed this record on May 23, 2013