Clinical trial NCT06460220: SAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth
Official title: SAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Suicide
Suicide, Attempted
Suicide and Self-harm
Suicide Threat
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2024-06-14
Enrollment: 65
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2 will include pilot testing of the SAFETY-P asynchronous parent intervention module with a nonrandomized case series of 10 families receiving services in CATC.

Phase 3 will include an RCT with N = 30 youth and parents, who will be randomized either to SAFETY-P + treatment as usual (TAU) or to TAU alone.
Primary purpose: TREATMENT

Brief summary: This project aims to adapt the parent component of Safe Alternatives for Teens and Youth (SAFETY) outpatient intervention to SAFETY-Parent (SAFETY-P), a self-paced interactive learning module for parents, to be implemented as an augmentation for youth being seen for suicidal ideation, suicidal behavior, or recent suicide attempts across multiple settings at Nationwide Children's Hospital (NCH, Columbus, Ohio).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

For Phase 1 interviews and focus groups:

1. Youth or young adults (\<25 years) with prior suicidal ideation or suicide attempts; parents whose child had a history of suicidal ideation and/or suicide attempt before age 18; medical or behavioral health provider of suicidal youth; and parents whose child died from suicide before age 18

For Phase 2 and the Phase 3:

1. Youth is currently in treatment with the Critical Assessment and Treatment Clinic (CATC) at NCH for suicidal thoughts or behaviors
2. Youth is between the ages of 10-18 (18-year-old youth must still be in high school and living at home with parents for duration of the study)
3. At least one parent is able to participate
4. Youth and parent are fluent in English

Exclusion Criteria:

For all four Phase 1 groups:

1. Cannot read or speak English (given focus group to be conducted in English

For Phase 2 and Phase 3 participants:

1. The youth or parent has an acute psychiatric or medical condition that would interfere with their ability to participate in study procedures
2. Lack of access to a digital device (smartphone, iPad, tablet computer, desktop, laptop PC)

Primary outcomes:
measure: Satisfaction with intervention on the Peabody Treatment Progress Battery (PTPB) - Service Satisfaction Scale (SSS)
timeFrame: 1 month, 3 months
measure: Use of intervention as measured by information provided by the Brainer Learning Management System (LMS)
timeFrame: 1 month, 3 months
measure: Intervention feasibility and acceptability on the SAFETY-P Satisfaction Scale
timeFrame: 1 month, 3 months
measure: Intervention usability on the System Usability Scale
timeFrame: 1 month
measure: Intervention acceptability on the Mobile Application Rating Scale: User Version (uMARS)
timeFrame: 1 Month
measure: Utilization of mental health services on the Child and Adolescent Services Assessment: Brief and Adapted version (CASA)
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months
timeFrame: Baseline, 1 month, 3 months
measure: Change from baseline in suicidal ideation severity on the Suicidal Ideation Questionnaire-Junior (SIQ-JR) at 1 month and 3 months
timeFrame: Baseline, 1 month, 3 months
measure: Youth psychopathology as measured by the Child Behavior Checklist (CBCL)
timeFrame: Baseline
measure: Youth psychopathology as measured by the Youth Self-Report (YSR)
timeFrame: Baseline
measure: 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
timeFrame: Baseline, 1 month, 3 months
measure: 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
timeFrame: Baseline, 1 month, 3 months
measure: Change from baseline in parent emotional dysregulation on the Difficulties in Emotion Regulation Scale (DERS) at 1 month and 3 months
timeFrame: Baseline, 1 month, 3 months
measure: Parent psychopathology as measured by the Brief Symptom Inventory (BSI)
timeFrame: Baseline
measure: 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
timeFrame: Baseline, 1 month, 3 months
measure: 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
timeFrame: Baseline, 1 month, 3 months
measure: Change from baseline in family conflict measures on the Conflict Behavior Questionnaire (CBQ) at 1 month and 3 months
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Jennifer L Hughes, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: