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Behavioral Intervention

Dialectical Behavioral Therapy for Self-Harm (DBT-A&JJS Trial)

N/A

Waitlist Available

Led By Melissa D Grady, PhD

Research Sponsored by The Catholic University of America

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months to 12 months for cohort 1, six months for cohort 2

Awards & highlights

DBT-A&JJS Trial Summary

This trial aims to assess the feasibility, acceptability and effectiveness of DBT for youth in the GAJJS which addresses Self-injurious thoughts and behaviors, a serious public health concern.

Who is the study for?

This trial is for young people in the custody of the Georgia State Juvenile Justice System (GAJJS) who can understand English well enough to participate in therapy. They must have consent from a parent or guardian and be placed at one of eight facilities involved. Those with cognitive impairments that affect decision-making are not eligible.Check my eligibility

What is being tested?

The trial is testing Dialectical Behavior Therapy adapted for adolescents (DBT-A) within juvenile justice facilities, assessing its feasibility, acceptability, and preliminary effectiveness using a mixed-methods cross-over design.See study design

What are the potential side effects?

Since DBT-A involves psychological therapy rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort as they learn new coping skills to manage difficult emotions.

DBT-A&JJS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months to 12 months for cohort 1, six months for cohort 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months to 12 months for cohort 1, six months for cohort 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months to 12 months for cohort 1, six months for cohort 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Acceptance and Action Questionnaire II (AAQ-II)

The DBT-Ways of Coping Check List (DBT-WCCL)

The Life Problems Inventory (LPI)

+1 more

DBT-A&JJS Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2Experimental Treatment1 Intervention

Cohort 1 and 2 youth will then complete baseline assessments (see 4.5) and Cohort 2 will continue receiving TAU while Cohort 1 begins receiving DBT-A (randomized by facility to either in-person or via telehealth delivery) for the next six months while Cohort 1 staff continue consultation with DBT-A. After six months, Phase 2 of this study will conclude with the youth of Cohorts 1 and 2 completing their first follow-up assessment. The implementation plan will be altered accordingly based on feedback from stakeholders prior to the start of Phase 2. The modified implementation plan will be used in the training of the staff in DBT-A at the second four facilities prior to the launch of Phase 3.

Group II: Phase 3Active Control1 Intervention

Phase 3 will begin with making any modifications to the treatment protocol based on a review of feedback from stakeholder interviews from Phase 2. Cohort 2 facilities will be randomized to delivering DBT-A in-person or via telehealth (one long-term and one short-term facility will be assigned to each condition). Staff in Cohort 2 will receive training and consultation in DBT-A and implement either telehealth or in-person delivered DBT-A in their facilities. Cohort 1 facilities will cross-over from in-person delivery of DBT-A to telehealth delivery, or vice-versa, thereby facilitating a within-facility comparison of DBT-A delivery methods. After six months, Phase 3 will conclude with the youth of Cohorts 1 and 2 completing their second follow-up assessment and all stakeholders of Cohorts 1 and 2 completing stakeholder interviews.

Group III: No interventionActive Control1 Intervention

Cohort 2 will not receive any treatment during Phase 2 of the study, which is the first part of the clinical trial. They will serve as a comparison group for Cohort 1.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Catholic University of AmericaLead Sponsor

13 Previous Clinical Trials

2,532 Total Patients Enrolled

Butler HospitalOTHER

129 Previous Clinical Trials

16,418 Total Patients Enrolled

Melissa D Grady, PhDPrincipal InvestigatorCatholic University

Media Library

Dialectical Behavioral Therapy for Adolescents (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05583279 — N/A

Self-Harm Research Study Groups: Phase 3, Phase 2, No intervention

Self-Harm Clinical Trial 2023: Dialectical Behavioral Therapy for Adolescents Highlights & Side Effects. Trial Name: NCT05583279 — N/A

Dialectical Behavioral Therapy for Adolescents (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583279 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there age restrictions for participants of this research endeavor?

"This trial is accepting applicants aged 10 years or older and younger than 21."

Answered by AI

Could I gain admission to the research project?

"This clinical study is actively enrolling 300 adolescents aged 10-21 who have a history of suicidal ideation. Candidates must be able to communicate fluently in English, provide both parental/guardian and youth advocate consent, give written assent for the trial, and are currently under custody from Georgia's Juvenile Justice System (GAJJS) at one of 8 facilities participating in this research project."

Answered by AI

Are there any vacancies in the current research study?

"Clinicaltrials.gov shows that this medical study, originally posted on September 1st 2023 and last updated October 19th 2022, is not currently enrolling patients; however there are 222 alternative trials recruiting now."

Answered by AI