NCT07852429

Brief Summary

The goal of this pilot clinical trial is to explore the feasibility and acceptability of implementing an intervention for caregivers in our health care system. The intervention is intended to provide information and consultation to caregivers of youth ages 12-26 years old who are at risk of self-harm (i.e., suicidal behaviors and/or nonsuicidal self-injury). The intervention is based on principles of Dialectical Behavior Therapy, an evidence-based intervention for youth who engage in suicidal behaviors and nonsuicidal self-injury. Acceptability will be assessed through questionnaires and qualitative feedback. Feasibility will be assessed by tracking the amount of clinician resources needed and how long it takes to identify caregivers who want to participate. A group of caregivers who have lived experience of having a child at risk for self-harm will form an advisory board. The board will review the study methods and data; their advice will guide next steps.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2028

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Caregiver participant attendance rate

    The number of workshop and consultation sessions that caregivers attend will be used as a measure of acceptability.

    enrollment to 6 month follow-up

  • Caregiver participant survey & interview completion rate

    The number of surveys and interviews that caregivers complete will be a primary measure of feasibility and acceptability of study methods.

    enrollment to 6-month follow-up

  • Youth participant survey & interview completion rate

    The number of surveys and interviews that youth participants complete will be a primary measure of feasibility and acceptability of study methods.

    enrollment to 6-month follow-up

Study Arms (1)

Intervention

EXPERIMENTAL
Behavioral: Workshop and consultation for caregivers of at risk youth

Interventions

The caregiver intervention is provided via telehealth and uses principles and information adapted from Dialectical Behavior Therapy for Adolescents (DBT; Miller, Rathus, Linehan, 2007). It consists of 4 session, 90 minutes each, over a 4-week period. The information and actives during these sessions are intended to: (1) provide education about suicidal and self-injurious thoughts \& behaviors and effective interventions, (2) support caregivers to implement safety measures at home, (3) increase caregiver coping skills, and (4) teach caregivers skills to support youth behavior change. Caregivers who attend the sessions are encouraged to get consultation with the same provider outside of the sessions. Weekly "office hours" are scheduled and they can also make an ad hoc appointment. The consultation will be provided for up to 6 months following the sessions. Consultation is meant to help caregivers apply the information they learn in the sessions to their particular family situation.

Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • caregiver whose has a child age 12-26yo who is screens positive for risk of self-harm or suicide by a UCSF provider
  • speaks English

You may not qualify if:

  • no access to Zoom
  • child age 12-26 yo of a caregiver who consents to participate in study
  • For youth 12-17 yo, legal guardian must be one of the caregivers participating and they also consent for this youth to participate in the study
  • speaks English
  • no access to Zoom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

SuicideSelf-Injurious Behavior

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Sabrina Darrow, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Darrow, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2026

First Posted

October 1, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

April 28, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations