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

NCT ID: NCT06460220

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-10
• Study Completion Date: 2025-12-31

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.

Conditions

Suicide; Suicide, Attempted; Suicide and Self-harm; Suicide Threat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Safe Alternatives for Teens and Youth - Parent (SAFETY-P) + Treatment as Usual (TAU)

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. Participants will be provided with the SAFETY-P modules and complete follow-up measures after one month.

Phase 3 will include an RCT with N = 30 youth and parents, with half randomized to SAFETY-P + treatment as usual (TAU). Participants will complete measures at baseline, 1 month, and 3 months.

Group Type: EXPERIMENTAL

Safe Alternatives for Teens and Youth - Parent (SAFETY-P)

Intervention Type: BEHAVIORAL

The parent component of SAFETY focuses on enhancing parents' skills in supporting youth safety and managing parental distress during a suicidal crisis, ideal content to adapt for web-based delivery for parents. Specifically, parent information includes psychoeducation about suicide risk and protective factors, lethal means restriction, development of a parent distress tolerance plan (i.e., Parent Safety Plan), parent self-care and sources of support, strengthening the youth/parent relationship, and focus on care linkage for the youth. The SAFETY-P asynchronous parent intervention module will include text, interactive handouts, vignettes, and short video examples. The SAFETY-P module will allow for parents to access information and skills training on their own time, with the opportunity and encouragement to ask informed questions of their child's clinician; this will provide clinicians the opportunity to utilize their check-ins with parents more effectively to address youth safety.

Treatment As Usual (TAU)

Intervention Type: BEHAVIORAL

TAU will consist of treatment and case management as usual in the NCH Critical Assessment and Treatment (CATC) program. This may include individual and group therapy sessions for the youth, family therapy, medication management, and case management/discharge planning. Frequency of these services varies by availability and care linkage to ongoing outpatient care. We will track the number, type and length of all treatment and case management services provided as part of TAU in CATC to control for time spent in by parents and youth in TAU across study conditions. Additionally, the Child and Adolescent Services Assessment (CASA), a services use measure, will be utilized to capture any additional treatments and parents' involvement in those treatments.

Treatment As Usual (TAU)

Phase 3 will include an RCT with N = 30 youth and parents, with half randomized treatment as usual (TAU). Participants will complete measures at baseline, 1 month, and 3 months.

Group Type: OTHER

Treatment As Usual (TAU)

Intervention Type: BEHAVIORAL

TAU will consist of treatment and case management as usual in the NCH Critical Assessment and Treatment (CATC) program. This may include individual and group therapy sessions for the youth, family therapy, medication management, and case management/discharge planning. Frequency of these services varies by availability and care linkage to ongoing outpatient care. We will track the number, type and length of all treatment and case management services provided as part of TAU in CATC to control for time spent in by parents and youth in TAU across study conditions. Additionally, the Child and Adolescent Services Assessment (CASA), a services use measure, will be utilized to capture any additional treatments and parents' involvement in those treatments.

Interventions

Safe Alternatives for Teens and Youth - Parent (SAFETY-P)

The parent component of SAFETY focuses on enhancing parents' skills in supporting youth safety and managing parental distress during a suicidal crisis, ideal content to adapt for web-based delivery for parents. Specifically, parent information includes psychoeducation about suicide risk and protective factors, lethal means restriction, development of a parent distress tolerance plan (i.e., Parent Safety Plan), parent self-care and sources of support, strengthening the youth/parent relationship, and focus on care linkage for the youth. The SAFETY-P asynchronous parent intervention module will include text, interactive handouts, vignettes, and short video examples. The SAFETY-P module will allow for parents to access information and skills training on their own time, with the opportunity and encouragement to ask informed questions of their child's clinician; this will provide clinicians the opportunity to utilize their check-ins with parents more effectively to address youth safety.

Intervention Type: BEHAVIORAL

Treatment As Usual (TAU)

TAU will consist of treatment and case management as usual in the NCH Critical Assessment and Treatment (CATC) program. This may include individual and group therapy sessions for the youth, family therapy, medication management, and case management/discharge planning. Frequency of these services varies by availability and care linkage to ongoing outpatient care. We will track the number, type and length of all treatment and case management services provided as part of TAU in CATC to control for time spent in by parents and youth in TAU across study conditions. Additionally, the Child and Adolescent Services Assessment (CASA), a services use measure, will be utilized to capture any additional treatments and parents' involvement in those treatments.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Foundation for Suicide Prevention

OTHER

Sponsor Role: collaborator

Jennifer Hughes

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Hughes

Psychologist & Clinical Scholar, Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer L Hughes, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

STUDY00003043

Identifier Type: -

Identifier Source: org_study_id