Suicide PreventionNCT06499740
Adapting a Brief Suicide Intervention for Pediatric Primary Care: Enhancing Uptake and Impact
A study testing Pilot Intervention and Treatment as Usual in people with Suicide Prevention, run by University of Washington at 3 sites in United States.
Trial summary
Suicide is a leading cause of death among adolescents in the United States and improving access to high quality just-in-time suicide interventions to reduce risk has important public health implications. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- Pilot Intervention and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 May 2026to Mar 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Adolescent Inclusion Criteria:
- adolescent between the ages of 10 and 18 years old
- speaks fluent English
- current or recent suicide risk
Adolescent Exclusion Criteria:
- high suicide risk (in need of immediate crisis stabilization services such as inpatient medical or psychiatric hospitalization)
- does not speak fluent English
- does not have a primary care provider
Caregiver Inclusion Criteria:
- has a child who meets inclusion criteria
- Age 18 years or older
Caregiver Exclusion Criteria:
- does not have a child who meets inclusion criteria
- does not speak English
Provider Inclusion Criteria:
- Age 18 years or older
- works in primary care/outpatient healthcare setting
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Northwest Pediatrics
Centralia, Washington, 98531
Lily Lo, MD, (360) 736-6778, llo@nwpeds.com
- Recruiting
Richmond Pediatrics
Mountlake Terrace, Washington, 98043
Melissa Walsh, MD, (206) 546-2421, melissa.walsh@seattlechildrens.org
- Recruiting
Olympia Pediatrics
Olympia, Washington, 98506
Janelle Tiegs, (360) 413-8470, JanelleT@olypeds.com
About this study
Suicide is a leading cause of death among adolescents in the United States and improving access to high quality just-in-time suicide interventions to reduce risk has important public health implications. Integrating such interventions into routinely accessed settings, such as pediatric primary care, holds promise; however, many clinicians in these settings fail to adequately screen or intervene in youth suicidal thoughts and behaviors, representing a key barrier to reducing suicide. The proposed study is a pre-post quasi-experimental pilot feasibility and preliminary efficacy trial of a suicide prevention intervention informed by evidence based interventions including the SAFETY-Acute suicide prevention intervention implemented in 3 pediatric primary care clinics.
Read the detailed description
This project aims to take an innovative, user-centered design approach to improve suicide prevention in primary care settings to support primary care management of adolescents with suicidal thoughts and behaviors (STB), drawing on the evidence-based SAFETY-Acute (SAFETY-A; formerly known as Family Intervention for Suicide Prevention -aka FISP) intervention. In this trial, the investigators will conduct a pre-post quasi-experimental pilot feasibility and preliminary efficacy study of an adapted STB model of care compared to treatment as usual, with 3 primary care clinics. The trial will include 48 10-18-year-old patients with STB and their parents/caregivers. The investigators will assess acceptability and feasibility of the STB model of care, preliminary intervention impacts, and need for further adaptation.
- Conditions
- Suicide Prevention
- Being tested
- Pilot Intervention, Treatment as Usual
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot InterventionBehavioural
This intervention is a suicide prevention intervention that will be adapted from evidence-based suicide prevention interventions including the SAFETY-Acute program. The specific intervention components will be determined from information gathered in this study but the investigators anticipate will include components such as identifying strengths, coping skills, safety planning, lethal means restriction, psychoeducation, motivation building, and care linkage.
Treatment as UsualBehavioural
Treatment as usual delivered in participating clinics.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Arm 1 entails months 1-2 of this study. Treatment as usual will be delivered by providers to adolescent patients in their clinics during the first two months of this study. Treatment as usual will be defined by each individual clinic based on their existing clinic protocols. Receives: Behavioral: Treatment as Usual |
| Pilot Intervention | Experimental | Arm 2 entails months 3-4 of this study. Participating providers will deliver the adapted pilot intervention for the second half (months 3-4) of the pilot trial. The intervention will be based on the evidence-based suicide prevention interventions including the SAFETY-Acute protocol and will be adapted based on information from potential users prior to piloting. It is anticipated that both adolescent patients and their parents/caregivers will be involved in the intervention. Anticipated components of the intervention include psychoeducation, coping skills, safety planning, lethal means restriction, parenting skills, communication skills, identifying adolescent and family strengths, and linking to longer term care. Receives: Behavioral: Pilot Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
Feasibility of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater feasibility.)
Measured: Participant and providers complete approximately 2 weeks after completing intervention
Acceptability of Intervention Measure
Participant rated acceptability of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater acceptability.)
Measured: Participant and providers complete approximately 2 weeks after completing intervention
Intervention Appropriateness Measure
Participant rated appropriateness of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater appropriateness.)
Measured: Participant and providers complete approximately 2 weeks after completing intervention
Client Satisfaction Questionnaire
Participant rated satisfaction with the intervention (includes 8 items scored on a 4 point likert scale with higher scores representing greater satisfaction.)
Measured: Participant completes approximately 2 weeks after completing intervention
Intervention Usability Scale
Participant rated intervention usability (includes 10 items scored on a 5 point likert scale with greater total score representing greater usability).
Measured: Provider completes approximately 2 weeks after completing intervention
Secondary outcomes (3)
Parent Self Efficacy Scale
Caregiver rated self-efficacy of being able to keep youth safe (includes 5 items scored on a 5 point likert scale with greater total score representing greater parent self-efficacy).
Measured: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Adapted General Self-Efficacy Scale
Patient rated self-efficacy of being able to keep self safe (includes 10 items scored on a 4 point likert scale with greater total score representing greater self-efficacy).
Measured: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Adult Child Relationship Scale (ACRS)/Child Parent Relationship Scale (CPRS)
Patient and caregiver rated family involvement/relationship quality (includes 19 items scored on a 5 point likert scale with two subscales [closeness and conflict] where higher total score on each subscale represents greater closeness or conflict).
Measured: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start4 May 2026
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- It is anticipated that primary care physicians will deliver initial suicide risk screening, and will refer participating patients and their caregivers to an embedded social worker or integrated mental health clinician within the clinic who will deliver either treatment as usual (TAU; months 1 and 2 of the trial) or the pilot intervention (months 3 and 4 of the trial) to patients endorsing suicide risk. Patients will only participate in treatment as usual or the pilot intervention. Outcomes will be compared across the TAU and intervention conditions.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sarah Danzo, University of Washington
- Investigators
- Sarah Danzo, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499740
- Sponsor's protocol ID
- STUDY00019327
- Other IDs
- 1K23MH134229-01A1
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data may be made available upon reasonable request, subject to data use agreements, consent, and institutional policies as long as data does not have potential to identify the participant given the sensitive nature of this study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Brief Suicide Intervention for Pediatric Primary Care: Enhancing Uptake and Impact
- ClinicalTrials.gov ID
- NCT06499740
- Acronym / sponsor ID
- STUDY00019327
- Conditions
- Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 12 Jul 2024 (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.
Suicide is a leading cause of death among adolescents in the United States and improving access to high quality just-in-time suicide interventions to reduce risk has important public health implications. Integrating such interventions into routinely accessed settings, such as pediatric primary care, holds promise; however, many clinicians in these settings fail to adequately screen or intervene in youth suicidal thoughts and behaviors, representing a key barrier to reducing suicide. The proposed study is a pre-post quasi-experimental pilot feasibility and preliminary efficacy trial of a suicide prevention intervention informed by evidence based interventions including the SAFETY-Acute suicide prevention intervention implemented in 3 pediatric primary care clinics.
Detailed description
This project aims to take an innovative, user-centered design approach to improve suicide prevention in primary care settings to support primary care management of adolescents with suicidal thoughts and behaviors (STB), drawing on the evidence-based SAFETY-Acute (SAFETY-A; formerly known as Family Intervention for Suicide Prevention -aka FISP) intervention. In this trial, the investigators will conduct a pre-post quasi-experimental pilot feasibility and preliminary efficacy study of an adapted STB model of care compared to treatment as usual, with 3 primary care clinics. The trial will include 48 10-18-year-old patients with STB and their parents/caregivers. The investigators will assess acceptability and feasibility of the STB model of care, preliminary intervention impacts, and need for further adaptation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is anticipated that primary care physicians will deliver initial suicide risk screening, and will refer participating patients and their caregivers to an embedded social worker or integrated mental health clinician within the clinic who will deliver either treatment as usual (TAU; months 1 and 2 of the trial) or the pilot intervention (months 3 and 4 of the trial) to patients endorsing suicide risk. Patients will only participate in treatment as usual or the pilot intervention. Outcomes will be compared across the TAU and intervention conditions.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Treatment as UsualArm 1 entails months 1-2 of this study. Treatment as usual will be delivered by providers to adolescent patients in their clinics during the first two months of this study. Treatment as usual will be defined by each individual clinic based on their existing clinic protocols. |
| Pilot Intervention | Experimental | Behavioral: Pilot InterventionArm 2 entails months 3-4 of this study. Participating providers will deliver the adapted pilot intervention for the second half (months 3-4) of the pilot trial. The intervention will be based on the evidence-based suicide prevention interventions including the SAFETY-Acute protocol and will be adapted based on information from potential users prior to piloting. It is anticipated that both adolescent patients and their parents/caregivers will be involved in the intervention. Anticipated components of the intervention include psychoeducation, coping skills, safety planning, lethal means restriction, parenting skills, communication skills, identifying adolescent and family strengths, and linking to longer term care. |
Who may qualify
- Ages
- 10 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 |
|---|---|---|
| Pilot InterventionThis intervention is a suicide prevention intervention that will be adapted from evidence-based suicide prevention interventions including the SAFETY-Acute program. The specific intervention components will be determined from information gathered in this study but the investigators anticipate will include components such as identifying strengths, coping skills, safety planning, lethal means restriction, psychoeducation, motivation building, and care linkage. | Behavioural | Pilot Intervention |
| Treatment as UsualTreatment as usual delivered in participating clinics. | Behavioural | Treatment as usual |
Primary outcome
Feasibility of Intervention Measure
Time frame: Participant and providers complete approximately 2 weeks after completing intervention
Feasibility of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater feasibility.)
Acceptability of Intervention Measure
Time frame: Participant and providers complete approximately 2 weeks after completing intervention
Participant rated acceptability of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater acceptability.)
Intervention Appropriateness Measure
Time frame: Participant and providers complete approximately 2 weeks after completing intervention
Participant rated appropriateness of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater appropriateness.)
Client Satisfaction Questionnaire
Time frame: Participant completes approximately 2 weeks after completing intervention
Participant rated satisfaction with the intervention (includes 8 items scored on a 4 point likert scale with higher scores representing greater satisfaction.)
Intervention Usability Scale
Time frame: Provider completes approximately 2 weeks after completing intervention
Participant rated intervention usability (includes 10 items scored on a 5 point likert scale with greater total score representing greater usability).
3 secondary outcomes
Parent Self Efficacy Scale
Time frame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Adapted General Self-Efficacy Scale
Time frame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
Adult Child Relationship Scale (ACRS)/Child Parent Relationship Scale (CPRS)
Time frame: Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention
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 16 Jul 2026.
- Individual participant dataSharing planned: Undecided. De-identified data may be made available upon reasonable request, subject to data use agreements, consent, and institutional policies as long as data does not have potential to identify the participant given the sensitive nature of this study.
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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.
Sarah Danzo, PhD principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilot Intervention and Treatment as Usual in people with Suicide Prevention, run by University of Washington at 3 sites 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Sarah Danzo, PhD (206-987-1786, sdanzo@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (time frame: Participant and providers complete approximately 2 weeks after completing intervention). The study lists 5 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 16 Jul 2026.