Adapting DBT for Children With DMDD: Pilot RCT

NCT01862549 | Completed DMC

• 1 other identifier: 1205012350
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines feasibility and preliminary efficacy of Dialectical Behavior Therapy adapted to children (DBT-C). DBT-C as compared to treatment-as-usual (TAU) is hypothesized to have lower drop-out rate, and higher treatment attendance and satisfaction. Further, DBT-C as compared to TAU will have significantly greater reduction in symptoms of Disruptive Mood Dysregulation disorder, including verbal and behavioral outbursts and angry/irritable mood.

Conditions

Disruptive Mood Dysregulation Disorder

Outcome Measures

Primary Outcomes (4)

• Attendance and drop-out rate measure

  32 weeks

• Therapy Satisfaction Questionnaire

  32 weeks

• Therapist Satisfaction Questionaire

  32 weeks

• Psychosocial Treatment Compliance Scale

  32 weeks

Secondary Outcomes (12)

• Clinical Global Impression Scale

  pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up

• Mood Symptoms Questionnnaire

  pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up

• Children Coping Strategies Checklist

  pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up

• Emotion Regulation Checklist

  pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up

• Child Behavior Checklist

  pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up

Study Arms (2)

DBT for children

EXPERIMENTAL

Dialectical Behavior Therapy for children is a 32 session intervention (it consists of 2 pre-treatment sessions and 30 treatment sessions; treatment sessions are to be delivered in 32 weeks total) with once per week meetings, including 30 min. individual child therapy, 20 min. meeting with a caregiver and 40 min. of skills training with both.

Behavioral: Dialectical Behavior Therapy for children

Treatment as Usual

ACTIVE COMPARATOR

Children in active comparison conditions will receive Treatment as Usual (TAU) that primarily consists of 32 weekly sessions of supportive individual psychotherapy and adjunctive family interventions. Individual therapy included cognitive behavioral skills training (e.g., psychoeducation, cognitive modifications, thought blocking) and non-directive supportive therapy. Family therapy includes parenting skills training (e.g., limit setting, reinforcement techniques), structuring household environment, and safety planning.

Behavioral: Treatment as Usual

Interventions

Dialectical Behavior Therapy for children BEHAVIORAL

DBT for children

Treatment as Usual BEHAVIORAL

Treatment as Usual

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 7 years 0 months to 12 years 11 months
• Meet criteria for Disruptive Mood Dysregulation Disorder on DSM-IV
• Stabilized on psychiatric medication (at least 6 weeks).
• Able to be treated on the outpatient basis
• Children with suicidal ideation, suicidal behavior and non-suicidal self-injury will be included (assessed using Columbia Suicide and Self-Injury Severity Rating Scale) unless other interventions are indicated (e.g., hospitalization, medication).

You may not qualify if:

• Documented cognitive disability ( if records are not available will use \< 85 IQ on Wechsler Intelligence Scale for Children-IV Information and Block Design subtests).
• Current diagnosis of a psychotic disorder (on K-SADS-PL)
• Pervasive Developmental Disorder (on K-SADS-PL)
• Child in the English as Second Language program at school and/or caregivers have language difficulties as per self-report
• Child is in state custody.
• As consistent with DMDD diagnosis, child's co-morbid conditions better account for disruptive mood.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

Related Publications (1)

• Perepletchikova F, Nathanson D, Axelrod SR, Merrill C, Walker A, Grossman M, Rebeta J, Scahill L, Kaufman J, Flye B, Mauer E, Walkup J. Randomized Clinical Trial of Dialectical Behavior Therapy for Preadolescent Children With Disruptive Mood Dysregulation Disorder: Feasibility and Outcomes. J Am Acad Child Adolesc Psychiatry. 2017 Oct;56(10):832-840. doi: 10.1016/j.jaac.2017.07.789. Epub 2017 Aug 10.

  PMID: 28942805 DERIVED

Related Links

• NCBI Link

MeSH Terms

Interventions

Dialectical Behavior Therapy; Therapeutics

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Francheska Perepletchikova, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 24, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

US (1)