PEACE Toolkit for Autism

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Non-English/Spanish speakers

Compensation: Varies

Number of Visits: 24

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new toolkit, called PEACE (Prevention of suicide: Education, Awareness, Connection, and Engagement), in helping early intervention providers coach caregivers of young children with autism. The study will assess the toolkit's impact on both caregivers' and children's outcomes, as well as its cost-effectiveness. Providers who do not adhere to the coaching strategies may receive additional support, such as group or individual facilitation. Families with young children diagnosed with autism or at high risk for autism, who are receiving early intervention services and can attend weekly coaching sessions, may be well-suited for this trial. As an unphased trial, this study offers families a unique opportunity to contribute to pioneering research that could enhance early intervention strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PEACE implementation toolkit is safe for early intervention providers and families of young children with autism?

Research has shown that the PEACE toolkit, initially developed to prevent suicide among veterans, has the potential to improve mental health. This toolkit provides resources and strategies to help individuals connect with others and remain engaged in their care. Although studies primarily focused on mental health, they found that the PEACE approach is generally well-received and does not cause significant side effects.

Since the PEACE toolkit is neither a medication nor a medical procedure, it lacks the physical risks associated with some other treatments. Instead, it offers tools and support, which are typically safe for participants. The absence of negative reports in past uses further supports its safety. Participants can feel confident that the toolkit is designed to support and enhance their current care with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PEACE Toolkit for Autism because it aims to enhance how providers coach parents of children with autism, which is crucial for effective intervention. Unlike traditional methods that often rely on static, one-size-fits-all resources, the PEACE approach offers personalized support. Providers struggling with adherence to coaching strategies can benefit from targeted group and individual facilitation, potentially improving their ability to help parents engage with and support their children. This adaptive support model could lead to more consistent and effective outcomes for families, addressing a key challenge in autism care.

What evidence suggests that the PEACE toolkit is effective for improving caregiver coaching in early intervention for autism?

Research shows that the PEACE Toolkit, initially designed to prevent suicide, is now being adapted to support families with young children who have autism. Although direct proof of its effectiveness for autism is not yet available, the PEACE approach has shown promise in enhancing social connections and involvement in mental health settings. In this trial, some providers who do not adhere to parent coaching strategies will receive additional support through group or individual facilitation, while others will continue using the PEACE online resources without further support. The toolkit focuses on coaching caregivers to improve their skills and provide better support for parents. Early results from using PEACE in similar situations suggest it might enhance communication and relationships, which are crucial in autism care. This study will examine these potential benefits for autism more closely. ^{1 2 4 5 6}

Who Is on the Research Team?

Melanie Pellecchia, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for early intervention providers and families with young children diagnosed with Autism Spectrum Disorder. It aims to enroll 200 providers and 400 parent-child pairs, focusing on those who are currently receiving or can benefit from early intervention services.

Inclusion Criteria

Provider has more than 5 children with/at risk for ASD on their caseload

Child has a classification of ASD or high ASD risk as determined by the EI system

Child is receiving EI services from a participating provider

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Initial Implementation

Early intervention providers receive training on Project ImPACT and begin using the PEACE Implementation Toolkit with families.

8 weeks

Weekly sessions

Intervention and Assessment

Providers' caregiver coaching fidelity is assessed, and non-adherent providers are randomized to different support strategies.

8 weeks

Bi-weekly assessments

Continued Intervention and Final Assessment

Providers continue with assigned support strategies, and final fidelity assessment is conducted.

8 weeks

Final assessment at week 24

Follow-up

Participants are monitored for caregiver and child outcomes, and qualitative interviews are conducted.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PEACE

Trial Overview The study tests the PEACE implementation toolkit which includes weekly individual facilitation, online resources, and group sessions. The goal is to see if this support improves how caregivers coach families of autistic children in early interventions.

How Is the Trial Designed?

Group I: Non Adherent: Individual Facilitation Experimental Treatment 1 Intervention

After 16 weeks, providers may be randomized to receive individual facilitation with an expert coach if they continue to be non adherent to the use of parent coaching strategies.

Group II: Non Adherent: Group Facilitation Experimental Treatment 1 Intervention

After 8 and 16 weeks, providers with low coaching adherence could be randomized to receive weekly group facilitation.

Group III: Adherent: Continue Online Resources Active Control 1 Intervention

Providers who are adherent to parent coaching strategies during the 8 and 16 week timepoints will not be randomized and continue to use the PEACE Online Resources. They will not receive further implementation supports.

Group IV: Non Adherent: Continue Online Resources Placebo Group 1 Intervention

After 8 and 16 weeks, providers with low coaching adherence could be randomized to continue using the PEACE online resources with no further implementation supports.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

Institute of Education Sciences

Collaborator

Trials

10

Recruited

3,200+

Published Research Related to This Trial

Out of 69 assessed depression and suicide prevention apps, only 5 (7%) included all six recommended suicide prevention strategies, highlighting a significant gap in adherence to evidence-based guidelines.

Several popular apps provided incorrect crisis helpline numbers, raising concerns about the safety and reliability of mental health resources available to users, particularly given that some apps had over a million downloads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention and depression apps' suicide risk assessment and management: a systematic assessment of adherence to clinical guidelines. Martinengo, L., Van Galen, L., Lum, E., et al.[2022]

The U.S. Department of Veterans Affairs Home-Based Primary Care (HBPC) program has developed an online suicide prevention toolkit specifically for mental health providers and their teams, addressing the unique needs of Veterans with multiple health conditions.

A needs assessment involving focus groups and surveys of 109 HBPC program directors and mental health providers revealed a demand for targeted training and additional resources for managing mental health issues, highlighting the importance of integrated care teams in suicide prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Suicide Prevention Toolkit for VA Home-Based Primary Care Teams. Mlinac, ME., Smith, RW., Siffert, KJ., et al.[2023]

The Autism Adapted Safety Plan (AASP) is the first safety plan specifically designed for autistic adults at risk of self-harm and suicidal behavior, aiming to provide structured support during crises.

This pilot study will assess the feasibility and acceptability of the AASP among 90 participants, focusing on their experiences and the effectiveness of recruitment methods, which could inform larger future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapted suicide safety plans to address self-harm, suicidal ideation, and suicide behaviours in autistic adults: protocol for a pilot randomised controlled trial. Rodgers, J., Goodwin, J., Nielsen, E., et al.[2023]

Suicide is a major public health crisis, with over 44,000 deaths in the US alone in 2015, highlighting the urgent need for effective suicide prevention strategies that integrate research into practice.

The article introduces the Assess, Intervene and Monitor for Suicide Prevention (AIM-SP) model, which provides a structured approach to implementing evidence-based practices in clinical settings, focusing on ongoing risk assessment and support for individuals at high risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Zero Suicide Model: Applying Evidence-Based Suicide Prevention Practices to Clinical Care. Brodsky, BS., Spruch-Feiner, A., Stanley, B.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/search/I_bJWIRR_0Kb3TKRVha0zw/project-details/10975924

Prevention of Suicide in Veterans Through Brief ... In response, we developed a promising suicide prevention strategy called Prevention of suicide: Education, Awareness, Connection, and Engagement (PEACE), which ...

2. withpower.com withpower.com/trial/phase-suicide-2-2021-b5286

PEACE App Intervention for Suicide Prevention in Veterans ... Trial Overview The study tests the PEACE intervention, which includes a mental health app and the VA-BIC program aimed at improving social connections and care ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04536935

Mobile Mental Health Apps for Suicide Prevention Results from this trial will be quickly disseminated through several avenues: (1) the UWAC website and ALACRITY Centers network; (2) through CREATIV Lab's ...

4. clinconnect.io clinconnect.io/trials/NCT04446468

Suicide Prevention Study of VA-BIC in the Veteran - ClinConnect To address this, the study is testing a new program called PEACE, which includes a mobile app designed to help Veterans stay connected with others and a program ...

5. hsrd.research.va.gov hsrd.research.va.gov/publications/vets_perspectives/July-Aug23-Peers-Aid-Veterans-Engagement-with-Mental-Health-Self-Care-Mobile-Apps.cfm

Peers Aid Veterans' Engagement with Mental Health Self ... Peers and Mental Health Apps: Veterans with lived experience are ideal for supporting the use of mobile apps for mental health self-management.

6. mentalhealth.va.gov mentalhealth.va.gov/suicide_prevention/docs/Toolkit_National_Guard_and_Reserve_Members_CLEARED_2-21-19.pdf

Mental Health and Suicide Prevention Resource Toolkit It highlights a variety of mental health and suicide prevention resources available through VA and in the community. Resources for Former Guard and Reserve ...