Adapting Dialectical Behavior Therapy for Children in Residential Care

NCT ID: NCT01547052

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-09-30

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.

Detailed 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.

Conditions

Childhood Aggression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DBT for children

Dialectical Behavior Therapy adapted for children

Group Type: EXPERIMENTAL

DBT for children

Intervention Type: 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

Enhanced Supportive-Educational Therapy

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

Group Type: ACTIVE_COMPARATOR

Enhanced Supportive-Educational therapy

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Enhanced Supportive-Educational therapy

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Dialectical Behavior Therapy adapted for Children; Enhansed TAU

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Green Chimneys Residential Treatment Center, Brewster, NY

UNKNOWN

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francheska Perepletchikova, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Green Chimneys Residential Treatment Center

Brewster, New York, United States

Countries

United States

Other Identifiers

1012007764

Identifier Type: -

Identifier Source: org_study_id