Skills Group for Children With Emotional Dysregulation and Their Parents

Dialectical Behavioral Therapy (DBT) Based Skills Group for Children With Emotional Dysregulation and Their Parents

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

1. Schizophrenia
2. Bipolar disorder
3. Psychosis i.e an overt thought disorder
4. Mental retardation
5. Severe learning disorders
6. Pervasive developmental disorders.
7. Children who have suffered brain injury.

Comparison group: Between 6 and 10 children matched for sex, parents age and education, socioeconomic status that fulfill the same clinical criteria for inclusion in the study as the study group. The comparison group will receive treatment as usual.

Procedure The children will participate in a group skills group over 20 sessions, each session an hour and a half. The parents will participate in a group skills group over 15 sessions, each session an hour and a half. Each group will be lead by two therapists. All the children will be evaluated by board certified child and adolescent psychiatrist and will be diagnosed according to the DSM IV-TR. The parents' the child and a teacher who is familiar with the child will fill in questionnaires before the beginning of the group, at the end of the group process and 6 months after the group ends.

The treatment protocol will be based on Linehan's Skills training manual for treating borderline personality disorder and on modifications made by Miller for adolescents. The groups will be conducted according to a treatment manual which will be written accordingly and modified in order to apply the skills to a younger population. Ancillary treatment ( e.g. pharmacotherapy) will be provided on an as needed basis.

The control group the data will be collected at similar intervals to those in the study group.

Written informed consent will be obtained from the child and a legal guardian.

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Study Overview

• Status: Unknown
• Conditions: Emotional Dysregulation; Dialectical Behavioral Therapy
• Intervention / Treatment: Other: Control Group; Behavioral: Participation in DBT Skills Group

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Beer Sheva, Israel
    • Recruiting
    • Soroka Medical Center
    • Contact: Moshe Lachish, MD; Phone Number: 972-86403017; Email: lmomo@mac.com
    • Sub-Investigator: Helene Sher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Schizophrenia
2. Bipolar disorder
3. Psychosis i.e an overt thought disorder
4. Mental retardation
5. Severe learning disorders
6. Pervasive developmental disorders.
7. Children who have suffered brain injury.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group; Treatment as usual	Other: Control Group; Treatment as usual
Experimental: Research Group; Participation in the DBT skills group	Behavioral: Participation in DBT Skills Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in social skills, emotional regulation and concentration	Social skills will be assessed using The Social Skills Rating System Questionnaire, Emotional regulation with The Difficulties in Emotion Regulation Scale, Hyper-activity and attention with the Conners Rating Scales. The parents Expressed emotions i.e. the intensity of criticism, or over-involvement will be assessed using The Five Minute Speech Sample. Behavioral and emotional functioning of the control group will be assessed using the same measures at the same time intervals. We expect to see a significant improvement on all scales in the research group but not in the control group.	1 Year

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: Principal Investigator: Moshe Lachish, MD, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: February 13, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): March 29, 2011
• Last Update Submitted That Met QC Criteria: March 27, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: SOR513611CTIL