Online Learning Module for Parents of Suicidal Youth

(SAFETY-P Trial)

Overseen By Anastasia Berg, M.Ed.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Jennifer Hughes

Disqualifiers: Acute psychiatric, Medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online learning module called SAFETY-Parent (SAFETY-P) to help parents support children with suicidal thoughts or behaviors. The goal is to determine if this module, used alongside standard treatments, can improve outcomes for these families. It targets families with youth already receiving treatment for suicidal thoughts or actions at Nationwide Children's Hospital. Families fit this trial if the youth is between 10-18 years old, is currently in treatment for suicidal issues, and both the youth and at least one parent can speak English and have access to a digital device. As an unphased trial, this study offers families a unique opportunity to contribute to innovative research that could enhance support for youth with suicidal thoughts.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this online learning module is safe for parents of suicidal youth?

Research has shown that the SAFETY program, on which SAFETY-P is based, is a respected method for helping young people at risk of suicide. Previous studies found that the SAFETY program effectively lowers the risk of suicide attempts and self-harm. Participants generally handled the program well, and no major side effects were reported.

SAFETY-P, designed for parents, builds on this proven program. The parent module itself has no known safety issues. It focuses on providing parents with resources and support to help their children, which is generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAFETY-P program because it offers a fresh approach to supporting parents of suicidal youth. Unlike traditional therapies that primarily focus on the youth themselves, SAFETY-P empowers parents through an online learning module, providing them with tools and strategies to effectively support their children. This method is convenient and accessible, allowing parents to engage at their own pace without the need for regular in-person appointments. By enhancing parental involvement and understanding, SAFETY-P aims to create a more supportive home environment, which could lead to improved outcomes for at-risk youth.

What evidence suggests that the SAFETY-P module is effective for parents of suicidal youth?

Research shows that the Safe Alternatives for Teens and Youth (SAFETY) program holds promise for helping young people with suicidal behavior. Studies have found that SAFETY effectively prevents suicide attempts in teens who have recently self-harmed. The program uses cognitive-behavioral therapy to help change how people think and act. It involves the whole family, including parents in the treatment process. In this trial, some participants will receive the SAFETY-P module, specifically for parents, providing tools to better support their children, alongside Treatment as Usual (TAU). Overall, the SAFETY program has shown positive results, suggesting that SAFETY-P could benefit families facing similar challenges. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer L Hughes, PhD, MPH

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for parents of young individuals who are dealing with suicidal thoughts, behaviors, or have recently attempted suicide. It's specifically designed to support these parents as they navigate their child's challenges.

Inclusion Criteria

I am under 25 and have thought about or attempted suicide, or I am a parent or provider of a child who has.

Exclusion Criteria

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)

Timeline for a Trial Participant

Intervention Adaptation for Online Delivery

Participants are screened for eligibility to participate in the trial

4 weeks

4 stakeholder focus groups

Case Series Iterative Adaptation

Pilot testing of SAFETY-P with a nonrandomized case series of 5 clinicians and 10 families

1 month

Participants use SAFETY-P for up to one month

Pilot RCT of SAFETY-P

Conduct a pilot RCT with N=30 youth and parents, randomized to SAFETY-P + TAU or TAU alone

3 months

Measures at baseline, 1 month, and 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up measures at 1 and 3 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The SAFETY-Parent (SAFETY-P) program, an online learning module for parents, is being tested. It aims to augment existing treatments for suicidal youth by providing additional support and resources to their parents.

How Is the Trial Designed?

Group I: Treatment As Usual (TAU) Experimental Treatment 1 Intervention

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 II: Safe Alternatives for Teens and Youth - Parent (SAFETY-P) + Treatment as Usual (TAU) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Jennifer Hughes

Lead Sponsor

Trials

2

Recruited

250+

American Foundation for Suicide Prevention

Collaborator

Trials

36

Recruited

10,500+

Published Research Related to This Trial

Safety planning, including lethal means safety (LMS) counseling, is crucial for reducing suicide and violence risk by helping at-risk patients make safer firearm storage decisions.

The article provides a framework and evidence for effectively delivering LMS counseling, emphasizing the importance of individualized safety recommendations and proper documentation of these discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Risk Management and Firearm-related Lethal Means Safety. Simonetti, JA., Wortzel, HS., Matarazzo, BB.[2023]

A 1-hour virtual training significantly improved clinicians' knowledge and self-efficacy in using electronic safety plans for suicide prevention, with lasting effects observed at a 6-month follow-up.

Among clinicians working with suicidal youth, 81% attempted to use the electronic safety plan template, and 63% completed it, indicating that this training can enhance the implementation of safety planning in community settings despite some challenges like technology issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Suicide Safety Planning Training on Clinician Knowledge, Self-Efficacy, and Use of Safety Plans in Community Mental Health Clinics. Whitmyre, ED., Esposito-Smythers, C., Goldberg, DG., et al.[2023]

The LINC to LIFE Safety Planning (L2L SP) training program, which lasts 150 minutes, significantly improved mental health providers' knowledge, perceived behavioral control (PBC), and intentions regarding safety planning for suicidal clients immediately after the training.

At a six-month follow-up, improvements in attitudes, PBC, and emotional responses were noted, suggesting that the training has lasting benefits, although declines in knowledge indicate a need for refresher sessions to maintain effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LINC to Life: Evaluation of a Safety Planning Training Program with Clinicians and Mental Health Staff. Bender, AM., Schuck, A., Peterson, AL., et al.[2022]

The SAFETY-A intervention significantly improved treatment linkage rates for racial-ethnic minority youths after emergency department treatment for suicidal episodes, compared to those receiving enhanced usual care.

This study involved 105 participants and suggests that SAFETY-A is an effective approach to promote mental health equity and continuity of care for at-risk youths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Care Linkage for Racial-Ethnic Minority Youths Receiving Emergency Department Treatment for Suicidality: SAFETY-A. Kodish, T., Lau, AS., Belin, TR., et al.[2023]

The pilot study involving 66 adolescents showed that the ASAP intervention, which includes a smartphone app for emotion regulation, did not significantly reduce suicide attempts post-discharge, but indicated a trend towards fewer attempts (16% vs. 31%).

Participants with a history of previous suicide attempts may benefit more from the ASAP intervention, suggesting that this program could be tailored for those at higher risk, and overall, the intervention and app were well-received by users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

As Safe as Possible (ASAP): A Brief App-Supported Inpatient Intervention to Prevent Postdischarge Suicidal Behavior in Hospitalized, Suicidal Adolescents. Kennard, BD., Goldstein, T., Foxwell, AA., et al.[2023]

Safety planning is a crucial intervention for adolescents at risk of suicide, but many do not utilize their plans after leaving psychiatric hospitals, highlighting a need for improved strategies.

The article proposes enhancing safety planning with motivational interviewing techniques to boost adolescents' motivation and confidence in using their safety plans, aiming to reduce the risk of recurrent suicidal crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing motivation and self-efficacy for safety plan use: Incorporating motivational interviewing strategies in a brief safety planning intervention for adolescents at risk for suicide. Micol, VJ., Prouty, D., Czyz, EK.[2023]

The SAFETY program, a cognitive-behavioral and family-focused treatment, significantly reduced the likelihood of suicide attempts in adolescents aged 12-18 who had recently engaged in self-harm, with a 100% survival rate without attempts in the SAFETY group compared to 67% in the control group at the 3-month follow-up.

This study, involving a randomized controlled trial, is the second to show that combining cognitive-behavioral therapy with family involvement can effectively protect high-risk youths from suicide attempts, highlighting the importance of family support in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Family Treatment for Suicide Attempt Prevention: A Randomized Controlled Trial. Asarnow, JR., Hughes, JL., Babeva, KN., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40306939/

Preventing suicide with Safe Alternatives for Teens and ... Conclusions: The results suggest that SAFETY is feasible and promising for youth with suicidal behaviour. Clinical implications: A large ...

2. mentalhealth.bmj.com mentalhealth.bmj.com/content/28/1/e301575

Preventing suicide with Safe Alternatives for Teens and ... Conclusions The results suggest that SAFETY is feasible and promising for youth with suicidal behaviour. Clinical implications A large ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05537623

Preventing Suicide With Safe Alternatives for Teens and ... Safe Alternatives for Teens and Youths (SAFETY) is a novel scalable suicide prevention program designed to fill this critical gap.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5474088/

Cognitive-Behavioral Family Treatment for Suicide Attempt ... Results support the efficacy of SAFETY for preventing suicide attempts in adolescents presenting with recent self-harm.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722920301188

The SAFETY Treatment for Suicidal/Self-Harming Youth SAFETY is a 12-week outpatient child and family-centered cognitive-behavioral treatment, informed by dialectical-behavior therapy, and designed to promote ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4289426/

The SAFETY Program: A Treatment-Development Trial of a ... A 12-week trial of the SAFETY Program, a cognitive-behavioral family intervention designed to increase safety and reduce suicide-attempt (SA) risk.