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Dialectical Behavior Therapy for Adolescents at Rutgers University

Primary Purpose

Borderline Personality Disorder in Adolescence

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DBT-A
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder in Adolescence focused on measuring borderline personality disorder, adolescence, suicide, substance use

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rutgers University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBT-A

Arm Description

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.

Outcomes

Primary Outcome Measures

Self-Injurious Thoughts and Behaviors Inventory (SITBI)
semi-structured interview designed to assess presence of suicide ideation, suicide attempts, self-injurious behaviors
Work and Social Adjustment Scale
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.

Secondary Outcome Measures

Difficulties in Emotion Regulation Scale (DERS)
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.
Borderline Symptom List (BSL-23)
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.
Brief Symptom Inventory (BSI)
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.

Full Information

First Posted
March 1, 2019
Last Updated
April 14, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT03861858
Brief Title
Dialectical Behavior Therapy for Adolescents at Rutgers University
Official Title
Dialectical Behavior Therapy for Adolescents at Rutgers University
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
November 18, 2028 (Anticipated)
Study Completion Date
November 18, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project expands our existing psychological services clinic (the Dialectical Behavior Therapy Clinic at Rutgers University; DBT-RU) to include an adolescent treatment arm. Adolescents aged 13-20 and at least one caregiver will be recruited to participate in a six-month treatment study. Adolescents will be eligible to participate if they meet at least 3 criteria for borderline personality disorder, with one of those criteria being either impulsive behavior or recurrent self-harm behavior. Participants will be assessed at baseline, three-months (mid-treatment), six-months (post-treatment, and three-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder in Adolescence
Keywords
borderline personality disorder, adolescence, suicide, substance use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBT-A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DBT-A
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-Injurious Thoughts and Behaviors Inventory (SITBI)
Description
semi-structured interview designed to assess presence of suicide ideation, suicide attempts, self-injurious behaviors
Time Frame
six months
Title
Work and Social Adjustment Scale
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
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.
Time Frame
six months
Title
Borderline Symptom List (BSL-23)
Description
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.
Time Frame
six months
Title
Brief Symptom Inventory (BSI)
Description
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.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dialectical Behavior Therapy for Adolescents at Rutgers University

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