SAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth

This research project has iterative aims focused on the development and pilot testing of the SAFETY-P asynchronous parent intervention module. Phase 1 will focus on finalizing SAFETY-P content for the online learning module. Phase 2 will be a small open case series integrating additional key stakeholder feedback via formative usability testing. Phase 3 will test the revised module in a pilot RCT, to establish methods and protocols for a future large-scale clinical trial.

Phase 1/Aim 1 (Intervention Adaptation for Online Delivery): Phase 1 will include 4 separate stakeholder focus groups (adolescents, parents, behavioral health \[BH\] inpatient and outpatient providers, and parent survivors of suicide loss) to advise on adaptations to SAFETY-P and development of the self-paced, interactive module to be used in Phase 2.

Aim 1: Adapt the parent component of SAFETY to content for the SAFETY-P asynchronous parent intervention module and determine feasibility and acceptability of SAFETY-P to this asynchronous module delivery.

Hypothesis (Hyp) 1.1: SAFETY content will be adapted successfully to SAFETY-P; stakeholders will report that use of an online asynchronous learning module for parents is feasible and acceptable based on qualitative coding outcomes.

Phase 2/Aim 1 (Case Series Iterative Adaptation): Phase 2 will include pilot testing of SAFETY-P with a nonrandomized case series of 5 clinicians and 10 families. Participants will be invited to use SAFETY-P for up to one month. Feedback from this case series will inform iterative adaptations to the SAFETY-P module.

Hyp 1.2: SAFETY-P will be feasible to use (parents will report using SAFETY-P at least twice during the one month, clinicians will report discussing SAFETY-P content with parents at least once during the one month).

Hyp 1.3: Parents and clinicians will report that use of SAFETY-P is acceptable via formative usability testing interview feedback and on measures of acceptability (System Usability Questionnaire rating of \>68; Mobile Application Rating Scale: User Version (uMARS) acceptable scores ≥ 3).

Phase 3/Aims 2-4 (Pilot RCT of SAFETY-P): To assess feasibility and acceptability of SAFETY-P, we will conduct a pilot RCT with N=30 youth and parents, who will be randomized to either SAFETY-P + treatment as usual (TAU) or to TAU alone.

Aim 2: Conduct a pilot study of SAFETY-P. Outcomes will include study recruitment and retention rates, SAFETY-P parent satisfaction ratings, clinician-report of SAFETY-P use and effectiveness, and adverse event reports.

Hyp 2.1: The sample can be recruited in 1 year. Hyp 2.2: \>80% will participate throughout the 3 months. Hyp 2.3: Parents will report using SAFETY-P ≥ 2 times. Hyp 2.4: Parents will report high satisfaction on the SAFETY-P Satisfaction Scale (acceptable item scores ≥ 3) and the Peabody Treatment Progress Battery, Service Satisfaction Scale (acceptable item scores ≥ 3).

Hyp 2.5: Clinicians will report high satisfaction on the SAFETY-P Satisfaction Scale (acceptable item scores ≥ 3).

Exploratory Aim 3 (Parent Outcomes): Investigate if SAFETY-P leads to changes parent functioning (the intervention "target") - at 1 and 3-month follow-up, we will measure between-group differences.

Hyp 3.1: SAFETY-P+TAU parents will have preferential outcomes on: a) parent emotion regulation, b) parent depressive symptoms, c) caregiver strain, d) family conflict, e) parent perceived self-efficacy to manage their child's suicidal crises, and f) parent expectations of adolescents' risk.

Exploratory Aim 4 (Youth Outcomes): Explore preliminary effectiveness of the SAFETY-P at decreasing youth suicide risk factors - we will measure between-group differences at 1 and 3-month follow-up.

Hyp 4.1: SAFETY-P+TAU youth will have preferential outcomes on: a) youth suicidal ideation (SI), b) suicide attempts (SA), c) non-suicidal self-injury (NSSI), d) and services use (including TAU sessions attended and use of higher levels of care for suicidal crises such as emergency department or inpatient hospitalization), e) family conflict, f) thwarted belongingness, and g) perceived burdensomeness.

• Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months [Срок оценки: Baseline, 1 month, 3 months]
• Change from baseline in suicidal ideation severity on the Suicidal Ideation Questionnaire-Junior (SIQ-JR) at 1 month and 3 months [Срок оценки: Baseline, 1 month, 3 months]
• Youth psychopathology as measured by the Child Behavior Checklist (CBCL) [Срок оценки: Baseline]
• Youth psychopathology as measured by the Youth Self-Report (YSR) [Срок оценки: Baseline]
• Change from baseline in depressive symptoms for youth and parent participants on the Center for Epidemiological Studies Depression Scale (CES-D) at 1 month and 3 months [Срок оценки: Baseline, 1 month, 3 months]
• Change from baseline in feelings of which measures thwarted belongingness and perceived burdensomeness for youth participants on the Interpersonal Needs Questionnaire-Adolescent Version (INQ) at 1 month and 3 months [Срок оценки: Baseline, 1 month, 3 months]
• Change from baseline in parent emotional dysregulation on the Difficulties in Emotion Regulation Scale (DERS) at 1 month and 3 months [Срок оценки: Baseline, 1 month, 3 months]
• Parent psychopathology as measured by the Brief Symptom Inventory (BSI) [Срок оценки: Baseline]
• Change from baseline in parent distress related to caring for a child with mental illness on the Caregiver Strain Questionnaire at 1 month and 3 months [Срок оценки: Baseline, 1 month, 3 months]
• Change from baseline in parental confidence in their ability to prevent or manage a suicidal crisis on the Parent Self-Efficacy for Suicide and the Self-Assessed Expectations of Suicide Risk Scale, Adapted for Parents at 1 month and 3 months [Срок оценки: Baseline, 1 month, 3 months]
• Change from baseline in family conflict measures on the Conflict Behavior Questionnaire (CBQ) at 1 month and 3 months [Срок оценки: Baseline, 1 month, 3 months]