- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03861858
Dialectical Behavior Therapy for Adolescents at Rutgers University
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shireen L Rizvi, PhD
- Phone Number: 848-445-3914
- Email: slrizvi@gsapp.rutgers.edu
Study Locations
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New Jersey
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Piscataway, New Jersey, United States, 08854
- Rutgers University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 13-17 years or 18-20 if still living at home with parent.
- Agreement of at least one responsible adult parent/caregiver to participate in treatment.
- Agreement to take part in assessments, videotaping/audiotaping and coding of their sessions by research personnel.
- Agreement to pay for mental health services at the DBT- RU on a sliding scale, and to participate in research assessments as volunteers.
- Residence within commuting distance of clinic (< 45 minutes).
- Agreement to discontinue other forms of talk therapy for duration of DBT program (does not refer to AA/NA programs or psychotropic medication management).
- Exhibits dysregulation within the past six months as evidenced by 1) intentional self-injury and/or suicide attempt and/or 2) substance use disorder.
- Meets two additional criteria for borderline personality disorder (BPD).
Exclusion Criteria:
- Clients who need mental health services not available at the DBT- RU, such as treatment for schizophrenia or life-threatening anorexia, or who are currently obtaining optimum professional treatment that should not be ended.
- Non-English speaking.
- IQ < 70.
- Unable to understand research consent forms.
- Court-ordered to participate in treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DBT-A
The standard treatment to be delivered to all participants is DBT-A, which is a treatment model adapted from DBT. DBT-A is an adaptation for adolescents with emotion dysregulation and BPD features (Miller, Rathus, & Linehan, 2007; Rathus & Miller, 2015).
DBT-A involves weekly individual therapy with the adolescent, weekly multifamily skills group in which adolescents and family members participate, as needed phone coaching, and weekly consultation team for the therapists.
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DBT-A is a multimodal therapy which consists of weekly individual therapy, weekly multifamily skills groups, as needed phone coaching, and weekly consultation team for the therapists.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Injurious Thoughts and Behaviors Inventory (SITBI)
Time Frame: six months
|
semi-structured interview designed to assess presence of suicide ideation, suicide attempts, self-injurious behaviors
|
six months
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Work and Social Adjustment Scale
Time Frame: six months
|
WSAS items are rated on a scale of 0 (No Impairment) to 8 (Severe Impairment).
Total scores are calculated by adding the scores of all 5 items.
The minimum score of the WSAS is 0 and the maximum score of the WSAS is 40.
Scores below 10 are associated with subclinical populations.
Scores between 10 and 20 are associated with significant impairment, but less severe clinical symptomology.
Scores above 20 are associated with moderately severe or worse psychopathology.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: six months
|
The DERS is a 36-item measure of the six facets of emotion regulation. DERS items are rated on a scale of 1 (Almost Never 0-10%) to 5 (Almost Always 91-100%). The DERS total score ranges from 36-180. The total score is the sum of all subscales. Higher scores suggest greater problems with emotion regulation. |
six months
|
Borderline Symptom List (BSL-23)
Time Frame: six months
|
The BSL is a 23-item measure that assesses specific symptoms of borderline personality disorder. BSL items are measured on a scale of 0 (Not at all) to 4 (Very strong). The sum of all 23 items serves as the global scale factor. The global factor minimum score of the BSL is 0 and the maximum score is 92. To generate scores that are comparable to the original BSL-95, the mean score must be calculated. Higher total scores are associated with more symptoms of borderline personality disorder. |
six months
|
Brief Symptom Inventory (BSI)
Time Frame: six months
|
The BSI is a 53-item measure of psychological distress and psychological symptoms. BSI items are rated on a scale from 0 (Not at all) to 5 (Extremely). The BSI consists of 9 symptom dimensions and 3 global indices of stress. All 9 dimensions (Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism) have a score range from 0-5. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The 3 global indices of stress are Global Severity Index, Positive Symptom Total, and Positive Symptom Distress Index. |
six months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018001563
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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