Autism Spectrum DisorderNCT06374381
PEACE for ImPACT Study
A study testing PEACE Online Resources, PEACE Weekly Group Facilitation and PEACE Weekly Individual Facilitation in people with Autism Spectrum Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- PEACE Online Resources, PEACE Weekly Group Facilitation and PEACE Weekly Individual Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to Nov 2027
- 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 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Provider is employed by a Philadelphia EI agency
- Provider has > 5 children with/at risk for ASD on their caseload.
- Child is receiving EI services from a participating provider.
- Child has a classification of ASD or high ASD risk as determined by the EI system.
- Child is not transitioning from EI services for at least 6 months.
- Caregiver speaks English or Spanish (Project ImPACT materials are available in Spanish).
- Caregiver is willing to participate in weekly coaching sessions.
Who cannot join
- 1. Participants will be excluded if they do not speak English or Spanish, as the published intervention materials are currently available in English and Spanish and the research team is able to communicate with participants in English or Spanish only.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Center for Mental Health
Philadelphia, Pennsylvania, 19104
About this study
Official title: Adaptive Trial of Parent Empowerment and Coaching in Early Intervention: PEACE for ImPACT Study
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.
Read the detailed description
Investigators are partnering with the two early intervention systems and their respective agencies in Philadelphia that serve young children receiving early intervention services under the age of 5. Investigators will enroll 200 early intervention providers who deliver services to young children in Philadelphia. All providers will receive training on Project ImPACT. The investigators will also recruit 400 parent-child dyads from participating providers' caseloads and follow them over a 6 month period. Providers will be given access to the PEACE Implementation Toolkit to aid their implementation of Project ImPACT with enrolled families. At week 8, providers caregiver coaching fidelity with enrolled families will be assessed. Non-adherent providers will be randomized to either 1) continue using the PEACE Online Resources or 2) receive added support through 8 weeks of group facilitation with an EI consultant. The fidelity assessment will occur again at week 16 of the intervention. Non-adherent providers will be re-randomized to either 1) continue using the PEACE Online Resources, 2) receive 8 weeks of group facilitation with an EI consultant or 3) receive 8 weeks of individual facilitation with an EI consultant. At week 24 investigators will assess implementation fidelity for a final time. Secondary outcomes related to caregiver and child outcomes will be assessed at baseline and week 24. Planned analyses for all research questions can be found in the research study protocol available for review.
Completion of this project could radically transform the Philadelphia EI system's capacity to implement caregiver coaching with families of young children with ASD by providing critical supports to historically marginalized families, thereby improving learning trajectories for many young children with ASD. Data gathered through this project will be directly generalizable to EI systems across the country and inform the large-scale implementation of caregiver-mediated interventions for ASD within other publicly funded EI systems.
- Conditions
- Autism Spectrum Disorder
- Being tested
- PEACE Online Resources, PEACE Weekly Group Facilitation, PEACE Weekly Individual Facilitation
- Keywords
- Early Intervention, Caregiver Mediated Interventions, Caregiver or Parent Coaching
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEACE Online ResourcesBehavioural
The PEACE online resource includes self-paced training modules that cover the foundations of caregiver coaching, caregiver perspectives towards coaching, strategies for aligning with caregivers and gaining buy-in for coaching, evidence-based strategies to empower caregivers from marginalized backgrounds, and strategies to improve collaboration and cohesion among providers working with the same child. Each module includes brief example videos, easy-to read infographics, tip sheets, and checklists to guide implementation. A virtual communication application, Slack, facilitates frequent communication, enhances social networks among providers, and creates social norms related to the use of caregiver coaching. Providers can post questions or suggestions, share resources, and receive updates about other providers' accomplishments. Consultants frequently post encouraging messages and progress updates to increase motivation and shared norms for coaching.
PEACE Weekly Group FacilitationBehavioural
Facilitation comprises interactive problem solving and support, a shared understanding of need for improvement, and a supportive interpersonal relationship. Providers participate in 12 weekly group facilitation meetings for one hour virtually with an expert consultant focused on auditing providers' fidelity to caregiver coaching through role-play and performance feedback. Each group meeting aligns with content from the PEACE online resource library modules.
PEACE Weekly Individual FacilitationBehavioural
Individual facilitation is delivered virtually for one hour each week for eight weeks with a consultant focused on reflection and problem solving any identified implementation barriers, as well as practice and performance feedback.
| Study group | Role | What they receive |
|---|---|---|
| Adherent: Continue Online Resources | No 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. |
| Non Adherent: Continue Online Resources | Placebo comparator | 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. Receives: Behavioral: PEACE Online Resources |
| Non Adherent: Group Facilitation | Experimental | After 8 and 16 weeks, providers with low coaching adherence could be randomized to receive weekly group facilitation. Receives: Behavioral: PEACE Weekly Group Facilitation |
| Non Adherent: Individual Facilitation | Experimental | 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. Receives: Behavioral: PEACE Weekly Individual Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool
The tool consists of 25 items, rated on a 5-point scale with a rating of 4 or 5 indicating acceptable adherence. A score of 80% indicates adherence on the overall measure (i.e., 80% of the items rated at 4 or 5).
Measured: Weeks 8, 16, and 24 weeks of intervention
Secondary outcomes (6)
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)
The PICCOLO is a checklist of 29 observable, developmentally supportive parenting behaviors with children ages 10-47 months. The PICCOLO has four domains: Affection, Responsiveness, Encouragement, and Teaching. Total scores on each domain are used to monitor change in parenting behaviors. The minimum score is a 0 and a maximum score is 58. Higher scores indicate higher occurrences of supportive behaviors.
Measured: 6 months (Baseline and Week 24)
Autism Impact Measure (AIM)
A 41-item parent report questionnaire designed to track incremental change in frequency and impact of core ASD symptoms. The frequency and impact of symptoms are determined by a 5-point scale. Higher scores on the measure indicate greater symptom severity.
Measured: 6 months (Baseline and Week 24)
Social Communication Checklist (SCC)
A 47-item parent report checklist that is used as part of the Project ImPACT program to help parents set their child's social communication goals and assess child progress. An initial psychometric evaluation suggests that it is reliable, sensitive to change after intervention, and strongly related to well-established measures of social-communication functioning. Respondents indicate whether a child uses a specific skill on a 3-point scale. Scores are summed for domain scores (Social Engagement, Expressive Communication, Receptive Communication, and Imitation/Play) and a Total Score. Higher scores indicate that skills are being used more frequently.
Measured: 6 months (Baseline and Week 24)
Confusion, Hubbub, and Order Scale (CHAOS)
A validated parent-report measure of disorder and chaos in the home will be used to measure home environmental factors that may interfere with the use of caregiver coaching. Responses are formatted as a True/False or Yes/No format. Once completed, the 15 items are summed for a Total Score. A higher score indicates more chaotic, disorganized, and hurried characteristics of the home.
Measured: Baseline
Acceptability, Appropriateness, and Adoption measure
A measure that specifically queries for respondents views about the usefulness, acceptability, and the extent to which they used the components of the toolkit. Respondents rate the toolkit's acceptability, appropriateness, and their use of the components on a 5-point scale. Higher scores indicate higher levels of acceptability, appropriateness, and adoption.
Measured: 6 months (Week 24)
Qualitative Interview
We will conduct qualitative interviews with 20% of the early intervention providers in each cohort. We will interview them using an interview guide with questions eliciting feedback on the PEACE Implementation Toolkit and the implementation supports that were provided.
Measured: 6 months (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Dec 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Education Sciences, Michigan State University
- Responsible party
- Principal investigator, Melanie Pellecchia, PhD, University of Pennsylvania
- Investigators
- Melanie Pellecchia, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374381
- Sponsor's protocol ID
- 854990
- Status last verified
- May 2026
- First submitted
- 19 Mar 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Trial of Parent Empowerment and Coaching in Early Intervention: PEACE for ImPACT Study
- ClinicalTrials.gov ID
- NCT06374381
- Acronym / sponsor ID
- 854990
- Conditions
- Autism Spectrum Disorder
- Keywords
- Early Intervention, Caregiver Mediated Interventions, Caregiver or Parent Coaching
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Institute of Education Sciences, Michigan State University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Apr 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.
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.
Detailed description
Investigators are partnering with the two early intervention systems and their respective agencies in Philadelphia that serve young children receiving early intervention services under the age of 5. Investigators will enroll 200 early intervention providers who deliver services to young children in Philadelphia. All providers will receive training on Project ImPACT. The investigators will also recruit 400 parent-child dyads from participating providers' caseloads and follow them over a 6 month period. Providers will be given access to the PEACE Implementation Toolkit to aid their implementation of Project ImPACT with enrolled families. At week 8, providers caregiver coaching fidelity with enrolled families will be assessed. Non-adherent providers will be randomized to either 1) continue using the PEACE Online Resources or 2) receive added support through 8 weeks of group facilitation with an EI consultant. The fidelity assessment will occur again at week 16 of the intervention. Non-adherent providers will be re-randomized to either 1) continue using the PEACE Online Resources, 2) receive 8 weeks of group facilitation with an EI consultant or 3) receive 8 weeks of individual facilitation with an EI consultant. At week 24 investigators will assess implementation fidelity for a final time. Secondary outcomes related to caregiver and child outcomes will be assessed at baseline and week 24. Planned analyses for all research questions can be found in the research study protocol available for review.
Completion of this project could radically transform the Philadelphia EI system's capacity to implement caregiver coaching with families of young children with ASD by providing critical supports to historically marginalized families, thereby improving learning trajectories for many young children with ASD. Data gathered through this project will be directly generalizable to EI systems across the country and inform the large-scale implementation of caregiver-mediated interventions for ASD within other publicly funded EI systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adherent: Continue Online Resources | No 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. |
| Non Adherent: Continue Online Resources | Placebo comparator | Behavioral: PEACE Online ResourcesAfter 8 and 16 weeks, providers with low coaching adherence could be randomized to continue using the PEACE online resources with no further implementation supports. |
| Non Adherent: Group Facilitation | Experimental | Behavioral: PEACE Weekly Group FacilitationAfter 8 and 16 weeks, providers with low coaching adherence could be randomized to receive weekly group facilitation. |
| Non Adherent: Individual Facilitation | Experimental | Behavioral: PEACE Weekly Individual FacilitationAfter 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. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Provider is employed by a Philadelphia EI agency
- Provider has > 5 children with/at risk for ASD on their caseload.
- Child is receiving EI services from a participating provider.
- Child has a classification of ASD or high ASD risk as determined by the EI system.
- Child is not transitioning from EI services for at least 6 months.
Key exclusion criteria (1 listed)
- 1. Participants will be excluded if they do not speak English or Spanish, as the published intervention materials are currently available in English and Spanish and the research team is able to communicate with participants in English or Spanish only.
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 |
|---|---|---|
| PEACE Online ResourcesThe PEACE online resource includes self-paced training modules that cover the foundations of caregiver coaching, caregiver perspectives towards coaching, strategies for aligning with caregivers and gaining buy-in for coaching, evidence-based strategies to empower caregivers from marginalized backgrounds, and strategies to improve collaboration and cohesion among providers working with the same child. Each module includes brief example videos, easy-to read infographics, tip sheets, and checklists to guide implementation. A virtual communication application, Slack, facilitates frequent communication, enhances social networks among providers, and creates social norms related to the use of caregiver coaching. Providers can post questions or suggestions, share resources, and receive updates about other providers' accomplishments. Consultants frequently post encouraging messages and progress updates to increase motivation and shared norms for coaching. | Behavioural | Non Adherent: Continue Online Resources |
| PEACE Weekly Group FacilitationFacilitation comprises interactive problem solving and support, a shared understanding of need for improvement, and a supportive interpersonal relationship. Providers participate in 12 weekly group facilitation meetings for one hour virtually with an expert consultant focused on auditing providers' fidelity to caregiver coaching through role-play and performance feedback. Each group meeting aligns with content from the PEACE online resource library modules. | Behavioural | Non Adherent: Group Facilitation |
| PEACE Weekly Individual FacilitationIndividual facilitation is delivered virtually for one hour each week for eight weeks with a consultant focused on reflection and problem solving any identified implementation barriers, as well as practice and performance feedback. | Behavioural | Non Adherent: Individual Facilitation |
Primary outcome
Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool
Time frame: Weeks 8, 16, and 24 weeks of intervention
The tool consists of 25 items, rated on a 5-point scale with a rating of 4 or 5 indicating acceptable adherence. A score of 80% indicates adherence on the overall measure (i.e., 80% of the items rated at 4 or 5).
6 secondary outcomes
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)
Time frame: 6 months (Baseline and Week 24)
Autism Impact Measure (AIM)
Time frame: 6 months (Baseline and Week 24)
Social Communication Checklist (SCC)
Time frame: 6 months (Baseline and Week 24)
Confusion, Hubbub, and Order Scale (CHAOS)
Time frame: Baseline
Acceptability, Appropriateness, and Adoption measure
Time frame: 6 months (Week 24)
Qualitative Interview
Time frame: 6 months (Week 24)
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 12 May 2026.
Related trials for Autism Spectrum Disorder
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
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.
Melanie Pellecchia, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEACE Online Resources, PEACE Weekly Group Facilitation and PEACE Weekly Individual Facilitation in people with Autism Spectrum Disorder, run by University of Pennsylvania at 1 site in United States.
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 1 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool (time frame: Weeks 8, 16, and 24 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.