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Completed

NCT Number: NCT03861858

Dialectical Behavior Therapy for Adolescents at Rutgers University

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.

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Key information

Conditions

Borderline Personality Disorder in Adolescence Behavior Behavioral Symptoms Borderline Personality Disorder Chemically-Induced Disorders Mental Disorders Personality Disorders Self-Injurious Behavior Substance-Related Disorders Suicide

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University

Piscataway, New Jersey, 08854, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DBT-A

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2019
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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