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Completed

NCT Number: NCT01547052

Adapting Dialectical Behavior Therapy for Children in Residential Care

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.

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Key information

Age range

6 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Green Chimneys Residential Treatment Center

Brewster, New York, 10509-0719, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DBT for children

Behavioral

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 names: Dialectical Behavior Therapy adapted for Children

Enhanced Supportive-Educational therapy

Behavioral

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

Other names: Enhansed TAU

Primary outcomes

  1. Attendance Form

    Time frame: post-treatment at 30 weeks

Secondary outcomes

  1. Balloon Analog Risk Task

    Time frame: pre-treatment, week 6, 12, 18, 24, 30 of treatment and at 3 and 6 months follow-up

  2. 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

  3. Emotion Regulation Checklist

    Time frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up

  4. Children's Coping Strategies Checklist

    Time frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up

  5. Pleasure Scale for Children

    Time frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up

  6. Social Skills Rating Scale

    Time frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up

  7. Therapy Satisfaction Questionnaire

    Time frame: week 30

  8. Therapist Satisfaction Scale

    Time frame: week 30

  9. Milieu Staff Satisfaction Questionnaire

    Time frame: every 6 months

  10. Incident Report

    Time frame: pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up

  11. Psychosocial Treatment Compliance Scale

    Time frame: week 30

  12. Child Behavior Checklist

    Time frame: at pre-treatment, 6, 12, 18, 24, 30 weeks of treatment, and at 3 and 6 months follow-up

  13. Difficulty with Emotion Regulation Scale

    Time frame: pre-treatment

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Green Chimneys Residential Treatment Center, Brewster, NY

Registry information

Official study title

Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation

Acronym: DBT-C

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Mar 7, 2012
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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