Childhood AggressionDBT-CNCT01547052
Adapting Dialectical Behavior Therapy for Children in Residential Care
A study testing DBT for children and Enhanced Supportive-Educational therapy in people with Childhood Aggression, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60 children in the comparison condition). Read more about this study
- Who is it for?
- Ages 6 to 12 years, men only
- Conditions the study is for
- Childhood Aggression
- What is being tested?
- DBT for children and Enhanced Supportive-Educational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2016
- 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 6 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- age between 6 years 0 months and 12 years 11 months;
- male;
- in residential care at Green Chimneys;
- projected length of stay is at least 8 months.
Who cannot join
- pervasive developmental disorder;
- psychotic disorder;
- mental retardation; (all as per psychiatric evaluation at Green Chimneys);
- in care or custody of the Department of Social Services (DSS);
- caregivers do not speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Green Chimneys Residential Treatment Center
Brewster, New York, 10509-0719
About this study
Official title: Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation
I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60 children in the comparison condition).
II: Finalize therapist training manuals and educational materials to guide selection, training, and supervision of treatment providers.
Read the detailed description
Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment attendance, treatment satisfaction, and any differences in these rates by groups.
Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly greater treatment satisfaction rating by subjects, as well as by therapists and milieu staff.
Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and externalizing symptoms.
Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer internalizing and externalizing symptoms.
Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation, risk taking, and social skills, and reducing depression.
Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have significantly greater improvement in adaptive coping skills, emotion regulation, risk taking and impulsivity and social skills, and reducing depressive symptoms.
Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents.
Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer critical incidents, including psychiatric hospitalization, emergency room visits, total number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual acting out, running away, stealing, police involvement, etc.
- Conditions
- Childhood Aggression
- Being tested
- DBT for children, Enhanced Supportive-Educational therapy
- Keywords
- DBT, child, emotion regulation, behavior problems
- Medical subject headings
- Maple syrup urine disease, type 2, Emotional Regulation, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT for childrenBehavioural
Also called Dialectical Behavior Therapy adapted for Children
intervention consists of weekly individual 45 min. sessions, twice per week 60 min. group sessions, and every other week 90 min. sessions with parents
Enhanced Supportive-Educational therapyBehavioural
Also called Enhansed TAU
weekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions.
| Study group | Role | What they receive |
|---|---|---|
| DBT for children | Experimental | Dialectical Behavior Therapy adapted for children Receives: Behavioral: DBT for children |
| Enhanced Supportive-Educational Therapy | Active comparator | Enhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training Receives: Behavioral: Enhanced Supportive-Educational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance Form
Measured: post-treatment at 30 weeks
Secondary outcomes (13)
Balloon Analog Risk Task
Measured: pre-treatment, week 6, 12, 18, 24, 30 of treatment and at 3 and 6 months follow-up
Mood and Feelings Questionnaire
Measured: pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
Emotion Regulation Checklist
Measured: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Children's Coping Strategies Checklist
Measured: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Pleasure Scale for Children
Measured: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Social Skills Rating Scale
Measured: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Therapy Satisfaction Questionnaire
Measured: week 30
Therapist Satisfaction Scale
Measured: week 30
Milieu Staff Satisfaction Questionnaire
Measured: every 6 months
Incident Report
Measured: pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
Psychosocial Treatment Compliance Scale
Measured: week 30
Child Behavior Checklist
Measured: at pre-treatment, 6, 12, 18, 24, 30 weeks of treatment, and at 3 and 6 months follow-up
Difficulty with Emotion Regulation Scale
Measured: pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionAug 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AggressionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Green Chimneys Residential Treatment Center, Brewster, NY
- Responsible party
- Sponsor
- Investigators
- Francheska Perepletchikova, Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547052
- Sponsor's protocol ID
- 1012007764
- Acronym
- DBT-C
- Status last verified
- Jul 2018
- First submitted
- 1 Mar 2012
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation
- ClinicalTrials.gov ID
- NCT01547052
- Acronym / sponsor ID
- DBT-C / 1012007764
- Conditions
- Childhood Aggression
- Keywords
- DBT, child, emotion regulation, behavior problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Green Chimneys Residential Treatment Center, Brewster, NY
- Study start
- Apr 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Mar 2012 (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.
I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60 children in the comparison condition).
II: Finalize therapist training manuals and educational materials to guide selection, training, and supervision of treatment providers.
Detailed description
Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment attendance, treatment satisfaction, and any differences in these rates by groups.
Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly greater treatment satisfaction rating by subjects, as well as by therapists and milieu staff.
Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and externalizing symptoms.
Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer internalizing and externalizing symptoms.
Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation, risk taking, and social skills, and reducing depression.
Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have significantly greater improvement in adaptive coping skills, emotion regulation, risk taking and impulsivity and social skills, and reducing depressive symptoms.
Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents.
Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer critical incidents, including psychiatric hospitalization, emergency room visits, total number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual acting out, running away, stealing, police involvement, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBT for children | Experimental | Behavioral: DBT for childrenDialectical Behavior Therapy adapted for children |
| Enhanced Supportive-Educational Therapy | Active comparator | Behavioral: Enhanced Supportive-Educational therapyEnhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age between 6 years 0 months and 12 years 11 months;
- male;
- in residential care at Green Chimneys;
- projected length of stay is at least 8 months.
Key exclusion criteria (5 listed)
- pervasive developmental disorder;
- psychotic disorder;
- mental retardation; (all as per psychiatric evaluation at Green Chimneys);
- in care or custody of the Department of Social Services (DSS);
- caregivers do not speak English.
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 |
|---|---|---|
| DBT for childrenAlso: Dialectical Behavior Therapy adapted for Childrenintervention consists of weekly individual 45 min. sessions, twice per week 60 min. group sessions, and every other week 90 min. sessions with parents | Behavioural | DBT for children |
| Enhanced Supportive-Educational therapyAlso: Enhansed TAUweekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions. | Behavioural | Enhanced Supportive-Educational Therapy |
Primary outcome
Attendance Form
Time frame: post-treatment at 30 weeks
13 secondary outcomes
Balloon Analog Risk Task
Time frame: pre-treatment, week 6, 12, 18, 24, 30 of treatment and at 3 and 6 months follow-up
Mood and Feelings Questionnaire
Time frame: pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
Emotion Regulation Checklist
Time frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Children's Coping Strategies Checklist
Time frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Pleasure Scale for Children
Time frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Social Skills Rating Scale
Time frame: pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up
Therapy Satisfaction Questionnaire
Time frame: week 30
Therapist Satisfaction Scale
Time frame: week 30
Milieu Staff Satisfaction Questionnaire
Time frame: every 6 months
Incident Report
Time frame: pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up
Psychosocial Treatment Compliance Scale
Time frame: week 30
Child Behavior Checklist
Time frame: at pre-treatment, 6, 12, 18, 24, 30 weeks of treatment, and at 3 and 6 months follow-up
Difficulty with Emotion Regulation Scale
Time frame: pre-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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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.
Francheska Perepletchikova, Ph.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT for children and Enhanced Supportive-Educational therapy in people with Childhood Aggression, run by Weill Medical College of Cornell University at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jul 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance Form (time frame: post-treatment at 30 weeks). 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 23 Jul 2018.