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Dialectical Behavior Therapy for Adolescents at Rutgers University

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ClinicalTrials.gov Identifier: NCT03861858
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Shireen L. Rizvi, PhD, ABPP, Rutgers, The State University of New Jersey

Study Description
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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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder in Adolescence Behavioral: DBT-A Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dialectical Behavior Therapy for Adolescents at Rutgers University
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : November 18, 2028
Estimated Study Completion Date : November 18, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Behavioral: DBT-A
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



Eligibility Criteria
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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861858


Contacts
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Contact: Shireen L Rizvi, PhD 848-445-3914 slrizvi@gsapp.rutgers.edu

Locations
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United States, New Jersey
Rutgers University Recruiting
Piscataway, New Jersey, United States, 08854
Contact: Shireen L Rizvi, PhD    848-445-3942    slrizvi@gsapp.rutgers.edu   
Contact: Research Coordinator    848-445-3942    dbtru@gsapp.rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
More Information
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Responsible Party: Shireen L. Rizvi, PhD, ABPP, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03861858    
Other Study ID Numbers: 2018001563
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shireen L. Rizvi, PhD, ABPP, Rutgers, The State University of New Jersey:
borderline personality disorder
adolescence
suicide
substance use
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders