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

Suicide Clinical Trial

— SAFETY-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460220
• Other study ID #: STUDY00003043
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Nationwide Children's Hospital
• Contact: Jennifer L Hughes, PhD, MPH
• Phone: 614-722-6811
• Email: Jennifer.Hughes[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Jennifer Hughes	American Foundation for Suicide Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months	The C-SSRS is a validated, semi-structured interview that assesses both suicidal behavior and suicidal ideation (yes/no, frequency), with flexible time points and multiple informants depending on administrator purpose and need.	Baseline, 1 month, 3 months
Secondary	Change from baseline in suicidal ideation severity on the Suicidal Ideation Questionnaire-Junior (SIQ-JR) at 1 month and 3 months	The SIQ-JR is a 15-item modified version of the 30-item Suicidal Ideation Questionnaire. The SIQ-JR is a validated self-report measure of suicidal ideation severity in adolescents (7-point scale; 0="I never had this thought"; 6="Almost every day").	Baseline, 1 month, 3 months
Secondary	Youth psychopathology as measured by the Child Behavior Checklist (CBCL)	The CBCL is a standardized measure based on new national norms that were collected February 1999-January 2000. The CBCL is to be completed by the parent/caretaker who spends the most time with the child. The CBCL provides ratings for 20 competence and 120 problem items. The CBCL includes open-ended items covering physical problems, concerns, and strengths. Parents rate how true each item is now, or was within the past 6 months. The CBCL yields scores on internalizing, externalizing, and total problems as well as scores on DSM-IV related scales.	Baseline
Secondary	Youth psychopathology as measured by the Youth Self-Report (YSR)	The Youth Self-Report (YSR) is a widely used child-report measure that assesses problem behaviors along two "broadband scales": Internalizing and Externalizing. It also scores eight empirically based syndromes and DSM-oriented scales, and provides a summary of Total Problems. The measure assesses "Total Competency," which is a scale comprised of competency in activities, social functioning, and school performance.	Baseline
Secondary	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	The CES-D is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline, 1 month, 3 months
Secondary	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	The INQ-15 (19) is a self-report measure composed of 15 items that evaluate the main constructs of interpersonal suicide theory (8): perceived burdensomeness and thwarted belongingness. The items are answered on a 1-7 Likert scale (1 = Not at all true for me, 4 = Somewhat true for me, 7 = Very true for me).	Baseline, 1 month, 3 months
Secondary	Change from baseline in parent emotional dysregulation on the Difficulties in Emotion Regulation Scale (DERS) at 1 month and 3 months	The DERS is a brief, 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. The measure yields a total score as well as scores on six scales derived through factor analysis.	Baseline, 1 month, 3 months
Secondary	Parent psychopathology as measured by the Brief Symptom Inventory (BSI)	The BSI is a 53-item self-report inventory in which participants rate the extent to which they have been bothered (0 ="not at all" to 4="extremely") in the past week by various symptoms. The BSI has nine subscales designed to assess individual symptom groups: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. The BSI also includes three scales that capture global psychological distress.	Baseline
Secondary	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	The Caregiver Strain Questionnaire is a 21-item measure of self-reported strain experienced by caregivers and families of youth with emotional problems, with responses on a 5-point Likert scale (0 = Not at all, 4 = very much). It assesses the demands, responsibilities, difficulties, and negative psychological consequences of caring for children and adolescents with emotional and behavioral disorders.	Baseline, 1 month, 3 months
Secondary	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	The Parent Self-Efficacy for Suicide and the Self-Assessed Expectations of Suicide Risk Scale is a 12 item measure using a 10-point Likert scale (0=not at all confident, 5=somewhat confident, 10=completely confident). It measures parental confidence in caring for an adolescent experiencing suicidal ideation.	Baseline, 1 month, 3 months
Secondary	Change from baseline in family conflict measures on the Conflict Behavior Questionnaire (CBQ) at 1 month and 3 months	The Conflict Behavior Questionnaire (CBQ) is designed to obtain evaluations of parent and adolescent behavior directly from parent and adolescent. The questionnaire reliably measures whether or not a family is experiencing distress.	Baseline, 1 month, 3 months