Borderline Personality Disorder in Adolescence Clinical Trial
Official title:
Dialectical Behavior Therapy for Adolescents at Rutgers University
| Verified date | April 2023 |
| Source | Rutgers, The State University of New Jersey |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 100 |
| Est. completion date | November 18, 2028 |
| Est. primary completion date | November 18, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 13 Years to 20 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rutgers University | Piscataway | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Rutgers, The State University of New Jersey |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Self-Injurious Thoughts and Behaviors Inventory (SITBI) | semi-structured interview designed to assess presence of suicide ideation, suicide attempts, self-injurious behaviors | six months | |
| Primary | 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. | six months | |
| Secondary | 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. |
six months | |
| Secondary | 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. |
six months | |
| Secondary | 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. |
six months |