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

NCT06460220 | Enrolling By Invitation

• 1 other identifier: STUDY00003043
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Satisfaction with intervention on the Peabody Treatment Progress Battery (PTPB) - Service Satisfaction Scale (SSS)

  The PTPB is an integrated set of brief, reliable, and valid instruments that can be administered efficiently at low cost and can provide systematic feedback for use in treatment planning. It includes eleven measures completed by youth, caregivers, and/or clinicians that assess clinically-relevant constructs such as symptom severity, therapeutic alliance, life satisfaction, motivation for treatment, hope, treatment expectations, caregiver strain, and service satisfaction. The SSS provides a general indicator of how well youth and adult caregivers perceive the mental health organization's services.

  1 month, 3 months

• Use of intervention as measured by information provided by the Brainer Learning Management System (LMS)

  The LMS provides data on which components of the SAFETY-P modules were accessed, completion or non-completion of the component module, at which point in the content does discontinuation occur, time spent using the modules.

  1 month, 3 months

• Intervention feasibility and acceptability on the SAFETY-P Satisfaction Scale

  The SAFETY-P Satisfaction Scale consists of 8 items and measures acceptability of the SAFETY-P tool.

  1 month, 3 months

• Intervention usability on the System Usability Scale

  The System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The scale evaluates a wide variety of products and services, including hardware, software, mobile devices, websites and applications.

  1 month

• Intervention acceptability on the Mobile Application Rating Scale: User Version (uMARS)

  The uMARS is a simple tool that can be reliably used by end-users to assess the quality of mHealth apps. The uMARS provides a 20-item measure that includes 4 objective quality subscales-engagement, functionality, aesthetics, and information quality-and 1 subjective quality subscale.

  1 Month

• Utilization of mental health services on the Child and Adolescent Services Assessment: Brief and Adapted version (CASA)

  The CASA is a self and parent report instrument designed to assess the use of mental health services by children aged 8-18 yrs. The CASA includes 31 settings covering inpatient, outpatient, and informal services provided by a variety of child serving providers and sectors. It collects information on whether a service was ever used and more detailed information (length of stay/number of visits, focus of treatment) on services used in the recent past.

  Baseline, 1 month, 3 months

Secondary Outcomes (11)

• Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months

  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

  Baseline, 1 month, 3 months

• Youth psychopathology as measured by the Child Behavior Checklist (CBCL)

  Baseline

• Youth psychopathology as measured by the Youth Self-Report (YSR)

  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

  Baseline, 1 month, 3 months

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Safe Alternatives for Teens and Youth - Parent (SAFETY-P); Behavioral: Treatment As Usual (TAU)

Treatment As Usual (TAU)

OTHER

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.

Behavioral: Treatment As Usual (TAU)

Interventions

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

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

Treatment As Usual (TAU) 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.

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

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For Phase 1 interviews and focus groups:
• \. 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:
• Youth is currently in treatment with the Critical Assessment and Treatment Clinic (CATC) at NCH for suicidal thoughts or behaviors
• 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)
• At least one parent is able to participate
• Youth and parent are fluent in English

You may not qualify if:

• For all four Phase 1 groups:
• \. Cannot read or speak English (given focus group to be conducted in English
• For Phase 2 and Phase 3 participants:
• The youth or parent has an acute psychiatric or medical condition that would interfere with their ability to participate in study procedures
• Lack of access to a digital device (smartphone, iPad, tablet computer, desktop, laptop PC)

Sponsors & Collaborators

• Jennifer Hughes: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Suicide; Suicide, Attempted; Self-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jennifer L Hughes, PhD, MPH

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators, masked to condition, will conduct outcome assessments with parents and youth at baseline,1-month (the typical length of TAU in CATC prior to linking youth patients to ongoing outpatient care), and 3-month follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychologist & Clinical Scholar, Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)