NCT01299740

Brief Summary

Dialectical Behavioral Therapy (DBT) based skill groups for emotionally dysregulated children and their parents The investigators propose implementing a Dialectical Behavioral Therapy (DBT) skills group format for emotionally dysregulated children between the ages of 8 and 12 and their parents. Introduction Treatments available for children with emotional dysregulation and behavioral problems were shown to be only partially effective. DBT combines the western principles of changing behavior with the eastern principles of acceptance and mindfulness. Efficacy of DBT has been shown across a number of behavioral problems in adults and has been successfully adapted for adolescents. The next logical step is modification for younger children. The investigators chose DBT because of the observed similarities between adults and adolescents diagnosed with borderline personality disorder and the children who are referred to the investigators clinic with emotional dysregulation. Aims: To assess the ability to regulate emotions and problem behaviors before and after the proposed intervention Method: Population: Between 6-10 children between the ages 8-12 will be recruited from The child and adolescent psychiatric outpatient clinic at Soroka University Medical Center. Inclusion criteria Children suffering from emotional dysregulation All children and at least one parent speak Hebrew Exclusion criteria

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 29, 2011

Status Verified

February 1, 2011

Enrollment Period

11 months

First QC Date

February 13, 2011

Last Update Submit

March 27, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement in behavioral and emotional functioning

    We will assess behavioral and emotional functioning before, at the end and 6 months following the intervention. This will be assessed using the Achenbach questionnaires:(CBCL, TRF). Eight sub-areas will be measured at baseline, at the end of the intervention and six months later. The eight sub-scale symptoms are withdrawn, somatic complaints, anxiety and depression. social problems, thought problems. attention problems. aggressive behavior, and delinquent problems (Externalizing and internalizing).

    1 year

Secondary Outcomes (1)

  • Improvement in social skills, emotional regulation and concentration

    1 Year

Study Arms (2)

Control Group

OTHER

Treatment as usual

Other: Control Group

Research Group

EXPERIMENTAL

Participation in the DBT skills group

Behavioral: Participation in DBT Skills Group

Interventions

Participation of 20 group meetings lasting an hour and a half for the children, and 15 group meetings lasting an hour and a half for the parents.

Research Group

Treatment as usual

Control Group

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children suffering from emotional dysregulation
  • All children and at least one parent speak Hebrew

You may not qualify if:

  • Schizophrenia
  • Bipolar disorder
  • Psychosis i.e an overt thought disorder
  • Mental retardation
  • Severe learning disorders
  • Pervasive developmental disorders.
  • Children who have suffered brain injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, Israel

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Moshe Lachish, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Lachish, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 13, 2011

First Posted

February 18, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2012

Study Completion

July 1, 2012

Last Updated

March 29, 2011

Record last verified: 2011-02

Locations