Skills Group for Children With Emotional Dysregulation and Their Parents
NCT ID: NCT01299740
Last Updated: 2011-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2011-02-28
2012-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
*
*
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Group Based Parent Training for Children With Autism and Disruptive Behaviors
NCT04097457
An Intervention Program to Improve Emotion Regulation Among Parents of Children with ASD
NCT06598605
Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of Children With Behavior Problems
NCT06559813
Effects of Behavioral Training Groups for Parents of Children With Attention Deficit Hyperactivity Disorder
NCT06130852
DBT Skill Training for Autistic Adults With Difficulties in Emotion Regulation.
NCT07021274
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Group
Treatment as usual
Control Group
Treatment as usual
Research Group
Participation in the DBT skills group
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Control Group
Treatment as usual
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All children and at least one parent speak Hebrew
Exclusion Criteria
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.
9 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Soroka University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Soroka University Medical Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Moshe Lachish, MD
Role: PRINCIPAL_INVESTIGATOR
Soroka University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Soroka Medical Center
Beersheba, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SOR513611CTIL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.