Borderline Personality Disorder in AdolescenceNCT03861858
Dialectical Behavior Therapy for Adolescents at Rutgers University
A study testing DBT-A in people with Borderline Personality Disorder in Adolescence, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Borderline Personality Disorder in Adolescence
- What is being tested?
- DBT-A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- DBT-A
- Keywords
- borderline personality disorder, adolescence, suicide, substance use
- Medical subject headings
- Borderline Personality Disorder, Suicide, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT-ABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DBT-A | Experimental | 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. Receives: Behavioral: DBT-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Injurious Thoughts and Behaviors Inventory (SITBI)
semi-structured interview designed to assess presence of suicide ideation, suicide attempts, self-injurious behaviors
Measured: six months
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.
Measured: six months
Secondary outcomes (3)
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.
Measured: six months
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.
Measured: six months
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start2 Jan 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder in AdolescenceStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shireen L. Rizvi, PhD, ABPP, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861858
- Sponsor's protocol ID
- 2018001563
- Status last verified
- Jul 2024
- First submitted
- 1 Mar 2019
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavior Therapy for Adolescents at Rutgers University
- ClinicalTrials.gov ID
- NCT03861858
- Acronym / sponsor ID
- 2018001563
- Keywords
- borderline personality disorder, adolescence, suicide, substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBT-A | Experimental | Behavioral: DBT-AThe 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. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT-ADBT-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. | Behavioural | DBT-A |
Primary outcome
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
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.
3 secondary outcomes
Difficulties in Emotion Regulation Scale (DERS)
Time frame: six months
Borderline Symptom List (BSL-23)
Time frame: six months
Brief Symptom Inventory (BSI)
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT-A in people with Borderline Personality Disorder in Adolescence, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Injurious Thoughts and Behaviors Inventory (SITBI) (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.