NCT03861858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

4.8 years

First QC Date

March 1, 2019

Last Update Submit

July 29, 2024

Conditions

Keywords

borderline personality disorderadolescencesuicidesubstance use

Outcome Measures

Primary Outcomes (2)

  • Self-Injurious Thoughts and Behaviors Inventory (SITBI)

    semi-structured interview designed to assess presence of suicide ideation, suicide attempts, self-injurious behaviors

    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.

    six months

Secondary Outcomes (3)

  • Difficulties in Emotion Regulation Scale (DERS)

    six months

  • Borderline Symptom List (BSL-23)

    six months

  • Brief Symptom Inventory (BSI)

    six months

Study Arms (1)

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.

Behavioral: DBT-A

Interventions

DBT-ABEHAVIORAL

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.

DBT-A

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Borderline Personality DisorderSuicideSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersSelf-Injurious BehaviorBehavioral SymptomsBehaviorChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 4, 2019

Study Start

January 2, 2019

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations