NCT01547052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

4.3 years

First QC Date

March 1, 2012

Last Update Submit

July 19, 2018

Conditions

Keywords

DBT, child, emotion regulation, behavior problems

Outcome Measures

Primary Outcomes (1)

  • Attendance Form

    post-treatment at 30 weeks

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

DBT for children

EXPERIMENTAL

Dialectical Behavior Therapy adapted for children

Behavioral: DBT for children

Enhanced Supportive-Educational Therapy

ACTIVE COMPARATOR

Enhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training

Behavioral: Enhanced Supportive-Educational therapy

Interventions

intervention consists of weekly individual 45 min. sessions, twice per week 60 min. group sessions, and every other week 90 min. sessions with parents

Also known as: Dialectical Behavior Therapy adapted for Children
DBT for children

weekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions.

Also known as: Enhansed TAU
Enhanced Supportive-Educational Therapy

Eligibility Criteria

Age6 Years - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Green Chimneys Residential Treatment Center

Brewster, New York, 10509-0719, United States

Location

MeSH Terms

Conditions

Maple syrup urine disease, type 2Emotional RegulationMental Disorders

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Francheska Perepletchikova, Ph.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

April 1, 2011

Primary Completion

August 1, 2015

Study Completion

September 1, 2016

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations