Skills Group for Children With Emotional Dysregulation and Their Parents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Soroka University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01299740
First received: February 13, 2011
Last updated: March 27, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Emotional Dysregulation
Dialectical Behavioral Therapy
Behavioral: Participation in DBT Skills Group
Other: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dialectical Behavioral Therapy (DBT) Based Skills Group for Children With Emotional Dysregulation and Their Parents

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Improvement in behavioral and emotional functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Improvement in social skills, emotional regulation and concentration [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299740

Contacts
Contact: Moshe Lachish, MD 972-86403017 lmomo@mac.com
Contact: Helene Sher, MD 972-86403017 helenesher@hotmail.com

Locations
Israel
Soroka Medical Center Recruiting
Beer Sheva, Israel
Contact: Moshe Lachish, MD    972-86403017    lmomo@mac.com   
Sub-Investigator: Helene Sher, MD         
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Moshe Lachish, MD Soroka University Medical Center
  More Information

No publications provided

Responsible Party: Moshe Lachish MD, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01299740     History of Changes
Other Study ID Numbers: SOR513611CTIL
Study First Received: February 13, 2011
Last Updated: March 27, 2011
Health Authority: Israel: Clalit Health Services

ClinicalTrials.gov processed this record on August 19, 2014