SuicideSAFETY-PNCT06460220

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

A study testing Safe Alternatives for Teens and Youth - Parent (SAFETY-P) and Treatment As Usual (TAU) in people with Suicide and Suicide, Attempted, run by Jennifer Hughes at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 10 to 18 years
Conditions the study is for: Suicide, Suicide, Attempted, Suicide and Self-harm
What is being tested?: Safe Alternatives for Teens and Youth - Parent (SAFETY-P) and Treatment As Usual (TAU)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 2 sitesUnited States
Study dates: 10 Jun 2024to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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:
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

Who cannot join

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:
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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

Nationwide Children's Hospital
Columbus, Ohio, 43205
Nationwide Children's Hospital
Columbus, Ohio, 43215

Other trials in United States

About this study

Read the 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
Being tested: Safe Alternatives for Teens and Youth - Parent (SAFETY-P), Treatment As Usual (TAU)
Medical subject headings: Suicide, Suicide, Attempted, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06460220
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Treatment As Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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").
Measured: Baseline, 1 month, 3 months
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.
Measured: Baseline
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: Baseline, 1 month, 3 months
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 1 month, 3 months
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.
Measured: Baseline, 1 month, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 2024Dec 2026

First posted14 Jun 2024
Study start10 Jun 2024
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SuicideStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 65 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06460220
Sponsor's protocol ID: STUDY00003043
Acronym: SAFETY-P
Status last verified: Mar 2026
First submitted: 11 Jun 2024
Last updated: 16 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
Suicidal Ideation, Cognitive Control
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors

All Suicide trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth
ClinicalTrials.gov ID: NCT06460220
Acronym / sponsor ID: SAFETY-P / STUDY00003043
Conditions: Suicide, Suicide, Attempted, Suicide and Self-harm, Suicide Threat
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 65 participants (estimated)
Lead sponsor: Jennifer HughesUniversity, hospital or other
Collaborators: American Foundation for Suicide Prevention
Study start: 10 Jun 2024 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 14 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Safe Alternatives for Teens and Youth - Parent (SAFETY-P) + Treatment as Usual (TAU)	Experimental	Behavioral: Safe Alternatives for Teens and Youth - Parent (SAFETY-P), Behavioral: 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.
Treatment As Usual (TAU)	Other	Behavioral: 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.

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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
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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Safe Alternatives for Teens and Youth - Parent (SAFETY-P) + Treatment as Usual (TAU)
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.	Behavioural	Safe Alternatives for Teens and Youth - Parent (SAFETY-P) + Treatment as Usual (TAU), Treatment As Usual (TAU)

Primary outcome

Satisfaction with intervention on the Peabody Treatment Progress Battery (PTPB) - Service Satisfaction Scale (SSS)
Time frame: 1 month, 3 months
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.
Use of intervention as measured by information provided by the Brainer Learning Management System (LMS)
Time frame: 1 month, 3 months
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.
Intervention feasibility and acceptability on the SAFETY-P Satisfaction Scale
Time frame: 1 month, 3 months
The SAFETY-P Satisfaction Scale consists of 8 items and measures acceptability of the SAFETY-P tool.
Intervention usability on the System Usability Scale
Time frame: 1 month
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.
Intervention acceptability on the Mobile Application Rating Scale: User Version (uMARS)
Time frame: 1 Month
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.
Utilization of mental health services on the Child and Adolescent Services Assessment: Brief and Adapted version (CASA)
Time frame: Baseline, 1 month, 3 months
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.

11 secondary outcomes

Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months
Time frame: 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
Time frame: Baseline, 1 month, 3 months
Youth psychopathology as measured by the Child Behavior Checklist (CBCL)
Time frame: Baseline
Youth psychopathology as measured by the Youth Self-Report (YSR)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 1 month, 3 months
Parent psychopathology as measured by the Brief Symptom Inventory (BSI)
Time frame: 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
Time frame: 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
Time frame: Baseline, 1 month, 3 months
Change from baseline in family conflict measures on the Conflict Behavior Questionnaire (CBQ) at 1 month and 3 months
Time frame: Baseline, 1 month, 3 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
Individual participant dataSharing planned: No

Related trials for Suicide

Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
Suicidal Ideation, Cognitive Control
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jennifer L Hughes, PhD, MPH principal investigator

Nationwide Children's Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction with intervention on the Peabody Treatment Progress Battery (PTPB) - Service Satisfaction Scale (SSS) (time frame: 1 month, 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06460220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.