Emotional DysregulationNCT01299740
Skills Group for Children With Emotional Dysregulation and Their Parents
A study testing Participation in DBT Skills Group in people with Emotional Dysregulation and Dialectical Behavioral Therapy, run by Soroka University Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Emotional Dysregulation, Dialectical Behavioral Therapy
- What is being tested?
- Participation in DBT Skills Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children suffering from emotional dysregulation
- All children and at least one parent speak Hebrew
Who cannot join
- Schizophrenia
- Bipolar disorder
- Psychosis i.e an overt thought disorder
- Mental retardation
- Severe learning disorders
- Pervasive developmental disorders.
- Children who have suffered brain injury.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka Medical Center
Beersheba
Moshe Lachish, MD, 972-86403017, lmomo@mac.com
Helene Sher, MD
About this study
Official title: 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.
Read more
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
- Schizophrenia
- Bipolar disorder
- Psychosis i.e an overt thought disorder
- Mental retardation
- Severe learning disorders
- Pervasive developmental disorders.
- 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.
-
-
- Being tested
- Participation in DBT Skills Group, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in DBT Skills GroupBehavioural
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 GroupOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Treatment as usual Receives: Other: Control Group |
| Research Group | Experimental | Participation in the DBT skills group Receives: Behavioral: Participation in DBT Skills Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DysregulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Moshe Lachish, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299740
- Sponsor's protocol ID
- SOR513611CTIL
- Status last verified
- Feb 2011
- First submitted
- 13 Feb 2011
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavioral Therapy (DBT) Based Skills Group for Children With Emotional Dysregulation and Their Parents
- ClinicalTrials.gov ID
- NCT01299740
- Acronym / sponsor ID
- SOR513611CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Schizophrenia
- Bipolar disorder
- Psychosis i.e an overt thought disorder
- Mental retardation
- Severe learning disorders
- Pervasive developmental disorders.
- 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.
-
-
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Control GroupTreatment as usual |
| Research Group | Experimental | Behavioral: Participation in DBT Skills GroupParticipation in the DBT skills group |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children suffering from emotional dysregulation
- All children and at least one parent speak Hebrew
Key exclusion criteria (7 listed)
- Schizophrenia
- Bipolar disorder
- Psychosis i.e an overt thought disorder
- Mental retardation
- Severe learning disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in DBT Skills GroupParticipation 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. | Behavioural | Research Group |
| Control GroupTreatment as usual | Other | Control Group |
Primary outcome
Improvement in behavioral and emotional functioning
Time frame: 1 year
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 secondary outcome
Improvement in social skills, emotional regulation and concentration
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Lachish, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participation in DBT Skills Group in people with Emotional Dysregulation and Dialectical Behavioral Therapy, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moshe Lachish, MD (972-86403017, lmomo@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in behavioral and emotional functioning (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.