Adapting Dialectical Behavior Therapy for Children in Residential Care

Childhood Aggression Clinical Trial

— DBT-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547052
• Other study ID #: 1012007764
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: September 2016

Study information

• Verified date: July 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Childhood Aggression

Intervention

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
• Enhanced Supportive-Educational therapy
weekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions.

Locations

Country	Name	City	State
United States	Green Chimneys Residential Treatment Center	Brewster	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Green Chimneys Residential Treatment Center, Brewster, NY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance Form		post-treatment at 30 weeks
Secondary	Balloon Analog Risk Task		pre-treatment, week 6, 12, 18, 24, 30 of treatment and at 3 and 6 months follow-up
Secondary	Mood and Feelings Questionnaire		pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
Secondary	Emotion Regulation Checklist		pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Secondary	Children's Coping Strategies Checklist		pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Secondary	Pleasure Scale for Children		pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Secondary	Social Skills Rating Scale		pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Secondary	Therapy Satisfaction Questionnaire		week 30
Secondary	Therapist Satisfaction Scale		week 30
Secondary	Milieu Staff Satisfaction Questionnaire		every 6 months
Secondary	Incident Report		pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
Secondary	Psychosocial Treatment Compliance Scale		week 30
Secondary	Child Behavior Checklist		at pre-treatment, 6, 12, 18, 24, 30 weeks of treatment, and at 3 and 6 months follow-up
Secondary	Difficulty with Emotion Regulation Scale		pre-treatment