Clinical trial NCT01299740: Skills Group for Children With Emotional Dysregulation and Their Parents
Official title: Dialectical Behavioral Therapy (DBT) Based Skills Group for Children With Emotional Dysregulation and Their Parents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Dysregulation
Dialectical Behavioral Therapy
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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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Eligibility 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.

Primary outcomes:
measure: Improvement in behavioral and emotional functioning
timeFrame: 1 year
Secondary outcomes:
measure: Improvement in social skills, emotional regulation and concentration
timeFrame: 1 Year
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Moshe Lachish, MD
role: PRINCIPAL_INVESTIGATOR
References: