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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23MH134229-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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 low to moderate risk 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilot Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention Measure | Feasibility of the intervention (includes 4 items scored on a 5 point likert scale with higher scores representing greater feasibility.) | 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.) | 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.) | 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.) | 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). | Provider completes approximately 2 weeks after completing intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Ask Suicide Screening Questions (ASQ) | Exploratory suicide and mental health outcomes (includes 5 items scored as yes/no with greater number of yes or a yes on item 5 representing greater suicide risk). | Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention |
Adolescent Inclusion Criteria:
Adolescent Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
Provider Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Danzo, PhD | Contact | 206-987-1786 | sdanzo@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Danzo, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Pediatrics | Recruiting | Centralia | Washington | 98531 | United States |
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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| ID | Term |
|---|---|
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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 low to moderate suicide risk.
Patients will only participate in treatment as usual or the pilot intervention. Outcomes will be compared across the TAU and intervention conditions.
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| Treatment as Usual | Behavioral | Treatment as usual delivered in participating clinics. |
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| 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). | 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). | Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention |
| Revised Children's Anxiety and Depression Scale-25 |
Exploratory suicide and mental health outcomes (includes 25 items scored on a 4 point likert scale with higher total score representing greater symptom severity). |
| Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention |
| Diagnostic and Statistical Manual of Mental Disorders-5 cross cutting assessment | Exploratory suicide and mental health outcomes (includes 25 items scored on a 4 point likert scale with higher scores representing greater symptom severity). | Participant completes at baseline, approximately 2 weeks after completing intervention, and again 2 months following the intervention |
| Richmond Pediatrics | Recruiting | Mountlake Terrace | Washington | 98043 | United States |
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| Olympia Pediatrics | Recruiting | Olympia | Washington | 98506 | United States |
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