CaregiversNCT07852429
A Pilot Study of a DBT-Informed Caregiver Risk Management Workshop
A study testing Workshop and consultation for caregivers of at risk youth in people with Caregivers and Suicide, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Caregivers, Suicide, Nonsuicidal Self Injury
- What is being tested?
- Workshop and consultation for caregivers of at risk youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Caregiver Participants Inclusion Criteria:
- 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
Caregiver Participants Exclusion Criteria:
- no access to Zoom
Youth Participants Inclusion Criteria:
- 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
Youth Participants Exclusion Criteria:
- no access to Zoom
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94107
About this study
Official title: DBT-informed Caregiver Risk Management to Achieve a Zero-Suicide System: A Pilot Study
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.
- Conditions
- Caregivers, Suicide, Nonsuicidal Self Injury, Adolescent, Young Adult
- Being tested
- Workshop and consultation for caregivers of at risk youth
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workshop and consultation for caregivers of at risk youthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Workshop & Consultation Intervention | Experimental | Not described Receives: Behavioral: Workshop and consultation for caregivers of at risk youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver participant attendance rate
The number of workshop and consultation sessions that caregivers attend will be used as a measure of acceptability.
Measured: 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.
Measured: 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.
Measured: enrollment to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion28 Apr 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabrina Darrow, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852429
- Sponsor's protocol ID
- P0581925
- Other IDs
- SRG-0-041-24
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 8 Oct 2026
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DBT-informed Caregiver Risk Management to Achieve a Zero-Suicide System: A Pilot Study
- ClinicalTrials.gov ID
- NCT07852429
- Acronym / sponsor ID
- P0581925
- Conditions
- Caregivers, Suicide, Nonsuicidal Self Injury, Adolescent, Young Adult
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 1 Oct 2026 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver Workshop & Consultation Intervention | Experimental | Behavioral: Workshop and consultation for caregivers of at risk youth |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Workshop and consultation for caregivers of at risk youthThe 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. | Behavioural | Caregiver Workshop & Consultation Intervention |
Primary outcome
Caregiver participant attendance rate
Time frame: enrollment to 6 month follow-up
The number of workshop and consultation sessions that caregivers attend will be used as a measure of acceptability.
Caregiver participant survey & interview completion rate
Time frame: enrollment to 6-month follow-up
The number of surveys and interviews that caregivers complete will be a primary measure of feasibility and acceptability of study methods.
Youth participant survey & interview completion rate
Time frame: enrollment to 6-month follow-up
The number of surveys and interviews that youth participants complete will be a primary measure of feasibility and acceptability of study methods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
Sabrina Darrow, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workshop and consultation for caregivers of at risk youth in people with Caregivers and Suicide, run by University of California, San Francisco 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?
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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Darrow, PhD ((415) 476-3395, Sabrina.Darrow@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver participant attendance rate (time frame: enrollment to 6 month follow-up). The study lists 3 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 8 Oct 2026.