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

600 Participants Needed

Trial Summary

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 data supports the effectiveness of the PEACE treatment for suicide prevention in autism?

Research shows that mobile apps can help manage suicide risk by tracking mood and thoughts, creating safety plans, and providing access to support networks. Additionally, training programs for frontline individuals have been effective in helping at-risk people get mental health treatment, and comprehensive approaches like the Zero Suicide Model have been successful in clinical settings. ^{1 2 3 4 5}

How is the PEACE Toolkit for Autism treatment different from other treatments for autism?

The PEACE Toolkit for Autism is unique because it combines a mobile mental health app with a focus on suicide prevention through education, awareness, connection, and engagement, specifically tailored for autistic adults who are at higher risk of suicidality. This approach is novel as it integrates technology with personalized support to address a critical gap in existing autism treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

Investigators will test the impact of the PEACE implementation toolkit and determine the level of implementation support needed to improve early intervention providers use of caregiver coaching with families of young children with autism who receive early intervention services. The study will also assess caregiver and child outcomes for families receiving caregiver coaching and the cost effectiveness of the PEACE implementation toolkit. The investigators will enroll 200 early intervention providers, and 400 parent-child dyads.

Research Team

Melanie Pellecchia, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Suicide prevention and depression apps' suicide risk assessment and management: a systematic assessment of adherence to clinical guidelines. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Brief gatekeeper training for suicide prevention in an ethnic minority population: a controlled intervention. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Development of a Suicide Prevention Toolkit for VA Home-Based Primary Care Teams. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Online suicide risk screening and intervention with college students: a pilot randomized controlled trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Zero Suicide Model: Applying Evidence-Based Suicide Prevention Practices to Clinical Care. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Measurement properties of tools used to assess suicidality in autistic and general population adults: A systematic review. [2019]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Measurement Properties of the Suicidal Behaviour Questionnaire-Revised in Autistic Adults. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

What do we know about suicidality in autism spectrum disorders? A systematic review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Suicidal Ideation and Self-inflicted Injury in Medicare Enrolled Autistic Adults With and Without Co-occurring Intellectual Disability. [2020]