Communication Disorder, ChildhoodNCT07148258
Evaluating Georgia Part C Implementation Outcomes
A study testing Project ImPACT Training As Usual, Project ImPACT Training Plus Co-Production and Routine Project ImPACT in people with Communication Disorder, Childhood and Autism, run by Emory University at 1 site in United States.
Trial summary
This study aims to answer the question: What is the best way to help Early Intervention (EI) providers deliver high-quality services to children with communication delays for autism? The primary goal of this project is to examine the outcomes associated with delivering Project ImPACT, an evidence-based autism… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Communication Disorder, Childhood, Autism
- What is being tested?
- Project ImPACT Training As Usual, Project ImPACT Training Plus Co-Production and Routine Project ImPACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to Sep 2028
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently employed or contracted by Georgia's EI system
- Maintain an active therapy caseload
- Fluent in English.
- Have a child under 36 months currently enrolled in services through Georgia's Early Intervention system
- Are being seen by a provider participating in Project ImPACT training and research
- Fluent in English.
Who cannot join
- Not meeting the eligibility criteria.
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, 1 recruiting
- Recruiting
Marcus Autism Center
Atlanta, Georgia, 30329
About this study
This study aims to answer the question: What is the best way to help Early Intervention (EI) providers deliver high-quality services to children with communication delays for autism?
The primary goal of this project is to examine the outcomes associated with delivering Project ImPACT, an evidence-based autism intervention that is delivered as part of routine training within Georgia's EI system. Providers in the study will receive one of two Project ImPACT training models to help us understand which training model helps providers learn Project ImPACT better. Specifically, this study will examine the: 1) the process and quality by which Project ImPACT is implemented and adapted by EI providers across the two training conditions; 2) factors that impact how well Project ImPACT is implemented; and 3) the child (i.e., social communication) and family (i.e., parent empowerment and fidelity) outcomes associated with receiving Project ImPACT.
Read the detailed description
This study aims to determine the: 1) implementation outcomes; and 2) preliminary parent and child outcomes associated with Project ImPACT when implemented within the Georgia Early Intervention (EI) system. Twenty EI providers will be trained in one of two Project ImPACT training models. Training will include the option for group consultation. This training is part of standard training requirements, so it is not considered research.
Participating caregivers who receive Project ImPACT will receive the program as part of their routine EI services. They will have two options to participate in this research: 1) complete surveys before and after participation in Project ImPACT (each set will take 20-30 minutes), as well as an exit interview; or 2) complete a confidential survey only after participating in Project ImPACT, which will take 20-30 minutes. All research activities will be conducted at the Marcus Autism Center.
- Conditions
- Communication Disorder, Childhood, Autism
- Being tested
- Project ImPACT Training As Usual, Project ImPACT Training Plus Co-Production, Routine Project ImPACT
- Keywords
- Caregivers, Early Intervention (EI) Providers, Early Intervention System, Project ImPACT, Social communication delays
- Medical subject headings
- Communication Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project ImPACT Training As UsualOther
Also called Usual ImPACT
Project ImPACT is an evidence-based autism intervention that teaches parents to use a blend of developmental and naturalistic behavioral intervention techniques across a variety of daily routines to enhance their child's social engagement, language, imitation, and play skills.
The typical training model for Project ImPACT includes a 6-hour, interactive online tutorial that walks providers through the core Project ImPACT intervention strategies. After completing the online tutorial, providers attend a live interactive workshop virtually that is spread across 4, 3.5-hour days (14 hours total). Providers receive 1 hour of consultation once every other week for an hour from a trained Project ImPACT consultant (research staff member) following training.
Project ImPACT Training Plus Co-ProductionOther
Also called Usual ImPACT + Supplements
Project ImPACT is an evidence-based autism intervention that teaches parents to use a blend of developmental and naturalistic behavioral intervention techniques across a variety of daily routines to enhance their child's social engagement, language, imitation, and play skills.
The second cohort for Project ImPACT training is a model in which providers receive the same typical Project ImPACT training activities, in addition to three supplemental modules on other common areas of concern for families and how best to integrate other topics within Project ImPACT to meet the diverse needs of families.
Routine Project ImPACTBehavioural
Project ImPACT is an evidence-based autism intervention that teaches parents to use a blend of developmental and naturalistic behavioral intervention techniques across a variety of daily routines to enhance their child's social engagement, language, imitation, and play skills. Project ImPACT is delivered with parents meeting once or twice each week for one hour over 12- 16 weeks. In each session, parents receive: 1) didactic instruction in intervention strategies; 2) modeling of the intervention techniques by the therapist; 3) live coaching from the therapist while practicing the strategies with their child; and 4) homework to practice the strategies at home with their child, 20 minutes each day across meaningful home routines.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention (EI) providers | Other | Early Intervention (EI) providers who serve young children with social communication delays and/or autism will report on their experiences delivering Project ImPACT via one of two training models. Providers will have the option of consenting to share videos of their Project ImPACT sessions to help us understand the quality of Project ImPACT delivery. Receives: Other: Project ImPACT Training As Usual; Other: Project ImPACT Training Plus Co-Production |
| Caregivers | Other | Caregivers of children under 36 months of age in the Georgia EI system who are receiving services within the EI system will report on their experiences with the providers who have been trained in one of the two Project ImPACT models.
Caregivers will either: 1) complete surveys before and after they receive Project ImPACT, or 2) complete a confidential survey after receiving Project ImPACT from their provider. Caregivers will have the option of consenting to share videos of their Project ImPACT sessions to help us understand the quality of Project ImPACT delivery. Receives: Behavioral: Routine Project ImPACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Project ImPACT Coaching Fidelity
Providers' Project ImPACT therapy sessions will be video recorded and will be scored retrospectively for use of core Project ImPACT strategies. The research team will measure the project fidelity by watching recorded videos of the sessions, which will allow the team to capture how effectively the adult implements a strategy. This will be scored using the Project ImPACT fidelity checklist. Provider fidelity for each intervention strategy will be rated by a trained coder using a 5-point Likert scale, with scores of 4 or greater indicating appropriate fidelity. An average score of 4 or higher on all of the strategies indicates that fidelity has been met for Project ImPACT.
Measured: Biweekly up to 20 weeks
Provider Co-Production Quality
Following each therapy session, providers will complete a brief 20-item survey in which they will be asked what their session looked like and the rationale for any adaptations described. Providers will first indicate how long in minutes their Project ImPACT session was. They will also indicate which Project ImPACT coaching activities they completed in their session (yes/no). Providers will then be asked to indicate which of 10 additional non-Project ImPACT topics they covered in their session and subsequently how long in minutes they spent covering the additional topics. The following information will then be calculated for each session: 1) Percent of possible coaching elements delivered; 2) Percent of time spent covering additional topics; 3) Percent of time delivering other topics.
Measured: Baseline; Weekly up to 12 weeks, and 6-months
Secondary outcomes (7)
Project ImPACT Self-Efficacy.
Providers will rate their self-efficacy using a 7-item measure that asks about their perceived skills delivering Project ImPACT core strategies. Providers will rate each item using a 10-point Likert scale (1 = not at all confident, 5 = somewhat confident, and 10 = completely confident). An increase in the mean score indicates that the intervention has successfully enhanced self-efficacy.
Measured: Baseline, 1-month after baseline (post-Project ImPACT training), and 12 months
Perceived Characteristics of the Intervention Scale (Project ImPACT Perceptions)
All providers will complete the Perceived Characteristics of the Intervention Scale (PCIS). The PCIS is a 12-item questionnaire that measures the perceived characteristics of an intervention that are thought to impact its uptake and use. The current study will use an abbreviated measure that includes the following dimensions: Relative Advantage (e.g., "Project ImPACT is more effective than other therapies I have used"), Compatibility (e.g., "Project ImPACT is aligned with my clinical judgement"), Complexity (e.g., "Project ImPACT is easy to use"), and Potential for Reinvention (e.g., "Project ImPACT can be adapted to meet the needs of my patients"). Participants will rate each item on a 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree). Higher scores generally indicate more positive perceptions of the intervention.
Measured: Study completion (on average 12 months)
The Family Outcome Survey (caregivers)
The Family Outcome Survey (FOS) measures family outcomes expected to change through participation in early intervention programs for children with disabilities and their caregivers. The FOS includes five outcomes: understanding your child's strengths, needs, and abilities; knowing your rights and advocating for your child; helping your child develop and learn; having support systems; and accessing the community. The FOS comprises 24 items, with four to six items per outcome. Responses range from not at all (1) to completely (5). To get overall scores, all the responses are summed for the items within each of the five outcome areas and the three helpfulness indicators.
The Early Childhood Technical Assistance (ECTA) Center recommends that scores of 5 or greater on the family outcome items be considered an indicator of outcome attainment. Scores below 5 may indicate areas requiring further improvement
Measured: Baseline and study completion (on average 6 months)
Parent Observation of Social Interaction
Parent Observation of Social Interaction (POSI). The POSI is a 7-item measure that asks caregivers to rate their child's use of social communication skills, including communication, gesturing, and play, with each question scored as either 0 or 1. A score of 3 or more indicates a positive screen, suggesting the child may be at risk and warrants further evaluation.
Measured: Baseline
Social Communication Checklist (caregivers)
Social Communication Checklist (SCC). The SCC was developed as part of the Project ImPACT curriculum. The SCC is a 70-item checklist; respondents indicate if a child uses each skill, "Rarely/Not Yet (1)," "Sometimes, but not consistently (2)," or "Usually, at least 75% of the time (3)." Items correspond with the social communication domains targeted in Project ImPACT: 10 social engagement items, 24 language/ communication items, and 13 imitation/play items, and were summed for domain scores and a Total Score. Each item reflecting abnormal behavior scores 1 point; others score 0.
Total Scores: Range from 0 to 39 for verbal children and 0-33 for nonverbal children. Higher scores indicate greater social communication impairment.
Measured: Baseline and study completion (on average 6 months)
Project ImPACT Fidelity for Parents.
The project fidelity for Parent behavior will be scored for correct use of the Project ImPACT intervention techniques during the first and final Project ImPACT sessions using the Project ImPACT fidelity checklist. Parent fidelity for each intervention strategy will be rated by a trained coder using a 5-point Likert scale, with scores of 4 or greater indicating appropriate fidelity.
Measured: Baseline and study completion (on average 6 months)
Project ImPACT Satisfaction.
All parents will complete a 16-item survey examining: 1) treatment acceptability; 2) perceived child social communication gains; 3) burden of the treatment on the family; and 4) frequency of program use. Parents will rate their agreement with statements reflecting these domains on a 7-point Likert scale (ranging from "Completely dissatisfied" to "Completely satisfied," with a neutral midpoint and intermediate options in between). A higher score indicates a higher level of satisfaction.
Measured: Study completion (on average 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start3 Sep 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication Disorder, ChildhoodStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Georgia Department of Public Health
- Responsible party
- Principal investigator, Katherine E. Pickard, Emory University
- Investigators
- Katherine E. Pickard, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148258
- Sponsor's protocol ID
- STUDY00010098
- Other IDs
- 1K23MH130651-01A1, 2025P013101
- Status last verified
- May 2026
- First submitted
- 22 Aug 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share the data related to the primary study outcomes and study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Georgia Part C Implementation Outcomes
- ClinicalTrials.gov ID
- NCT07148258
- Acronym / sponsor ID
- STUDY00010098
- Conditions
- Communication Disorder, Childhood, Autism
- Keywords
- Caregivers, Early Intervention (EI) Providers, Early Intervention System, Project ImPACT, Social communication delays
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Georgia Department of Public Health
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Aug 2025 (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.
This study aims to answer the question: What is the best way to help Early Intervention (EI) providers deliver high-quality services to children with communication delays for autism?
The primary goal of this project is to examine the outcomes associated with delivering Project ImPACT, an evidence-based autism intervention that is delivered as part of routine training within Georgia's EI system. Providers in the study will receive one of two Project ImPACT training models to help us understand which training model helps providers learn Project ImPACT better. Specifically, this study will examine the: 1) the process and quality by which Project ImPACT is implemented and adapted by EI providers across the two training conditions; 2) factors that impact how well Project ImPACT is implemented; and 3) the child (i.e., social communication) and family (i.e., parent empowerment and fidelity) outcomes associated with receiving Project ImPACT.
Detailed description
This study aims to determine the: 1) implementation outcomes; and 2) preliminary parent and child outcomes associated with Project ImPACT when implemented within the Georgia Early Intervention (EI) system. Twenty EI providers will be trained in one of two Project ImPACT training models. Training will include the option for group consultation. This training is part of standard training requirements, so it is not considered research.
Participating caregivers who receive Project ImPACT will receive the program as part of their routine EI services. They will have two options to participate in this research: 1) complete surveys before and after participation in Project ImPACT (each set will take 20-30 minutes), as well as an exit interview; or 2) complete a confidential survey only after participating in Project ImPACT, which will take 20-30 minutes. All research activities will be conducted at the Marcus Autism Center.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention (EI) providers | Other | Other: Project ImPACT Training As Usual, Other: Project ImPACT Training Plus Co-ProductionEarly Intervention (EI) providers who serve young children with social communication delays and/or autism will report on their experiences delivering Project ImPACT via one of two training models. Providers will have the option of consenting to share videos of their Project ImPACT sessions to help us understand the quality of Project ImPACT delivery. |
| Caregivers | Other | Behavioral: Routine Project ImPACTCaregivers of children under 36 months of age in the Georgia EI system who are receiving services within the EI system will report on their experiences with the providers who have been trained in one of the two Project ImPACT models. Caregivers will either: 1) complete surveys before and after they receive Project ImPACT, or 2) complete a confidential survey after receiving Project ImPACT from their provider. Caregivers will have the option of consenting to share videos of their Project ImPACT sessions to help us understand the quality of Project ImPACT delivery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Currently employed or contracted by Georgia's EI system
- Maintain an active therapy caseload
- Fluent in English.
- Have a child under 36 months currently enrolled in services through Georgia's Early Intervention system
- Are being seen by a provider participating in Project ImPACT training and research
Key exclusion criteria (1 listed)
- Not meeting the eligibility criteria.
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 |
|---|---|---|
| Project ImPACT Training As UsualAlso: Usual ImPACTProject ImPACT is an evidence-based autism intervention that teaches parents to use a blend of developmental and naturalistic behavioral intervention techniques across a variety of daily routines to enhance their child's social engagement, language, imitation, and play skills. The typical training model for Project ImPACT includes a 6-hour, interactive online tutorial that walks providers through the core Project ImPACT intervention strategies. After completing the online tutorial, providers attend a live interactive workshop virtually that is spread across 4, 3.5-hour days (14 hours total). Providers receive 1 hour of consultation once every other week for an hour from a trained Project ImPACT consultant (research staff member) following training. | Other | Early Intervention (EI) providers |
| Project ImPACT Training Plus Co-ProductionAlso: Usual ImPACT + SupplementsProject ImPACT is an evidence-based autism intervention that teaches parents to use a blend of developmental and naturalistic behavioral intervention techniques across a variety of daily routines to enhance their child's social engagement, language, imitation, and play skills. The second cohort for Project ImPACT training is a model in which providers receive the same typical Project ImPACT training activities, in addition to three supplemental modules on other common areas of concern for families and how best to integrate other topics within Project ImPACT to meet the diverse needs of families. | Other | Early Intervention (EI) providers |
| Routine Project ImPACTProject ImPACT is an evidence-based autism intervention that teaches parents to use a blend of developmental and naturalistic behavioral intervention techniques across a variety of daily routines to enhance their child's social engagement, language, imitation, and play skills. Project ImPACT is delivered with parents meeting once or twice each week for one hour over 12- 16 weeks. In each session, parents receive: 1) didactic instruction in intervention strategies; 2) modeling of the intervention techniques by the therapist; 3) live coaching from the therapist while practicing the strategies with their child; and 4) homework to practice the strategies at home with their child, 20 minutes each day across meaningful home routines. | Behavioural | Caregivers |
Primary outcome
Project ImPACT Coaching Fidelity
Time frame: Biweekly up to 20 weeks
Providers' Project ImPACT therapy sessions will be video recorded and will be scored retrospectively for use of core Project ImPACT strategies. The research team will measure the project fidelity by watching recorded videos of the sessions, which will allow the team to capture how effectively the adult implements a strategy. This will be scored using the Project ImPACT fidelity checklist. Provider fidelity for each intervention strategy will be rated by a trained coder using a 5-point Likert scale, with scores of 4 or greater indicating appropriate fidelity. An average score of 4 or higher on all of the strategies indicates that fidelity has been met for Project ImPACT.
Provider Co-Production Quality
Time frame: Baseline; Weekly up to 12 weeks, and 6-months
Following each therapy session, providers will complete a brief 20-item survey in which they will be asked what their session looked like and the rationale for any adaptations described. Providers will first indicate how long in minutes their Project ImPACT session was. They will also indicate which Project ImPACT coaching activities they completed in their session (yes/no). Providers will then be asked to indicate which of 10 additional non-Project ImPACT topics they covered in their session and subsequently how long in minutes they spent covering the additional topics. The following information will then be calculated for each session: 1) Percent of possible coaching elements delivered; 2) Percent of time spent covering additional topics; 3) Percent of time delivering other topics.
7 secondary outcomes
Project ImPACT Self-Efficacy.
Time frame: Baseline, 1-month after baseline (post-Project ImPACT training), and 12 months
Perceived Characteristics of the Intervention Scale (Project ImPACT Perceptions)
Time frame: Study completion (on average 12 months)
The Family Outcome Survey (caregivers)
Time frame: Baseline and study completion (on average 6 months)
Parent Observation of Social Interaction
Time frame: Baseline
Social Communication Checklist (caregivers)
Time frame: Baseline and study completion (on average 6 months)
Project ImPACT Fidelity for Parents.
Time frame: Baseline and study completion (on average 6 months)
Project ImPACT Satisfaction.
Time frame: Study completion (on average 6 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 19 May 2026.
- Individual participant dataSharing planned: Yes. The research team will share the data related to the primary study outcomes and study protocol.
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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.
Katherine E. Pickard, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project ImPACT Training As Usual, Project ImPACT Training Plus Co-Production and Routine Project ImPACT in people with Communication Disorder, Childhood and Autism, run by Emory University 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 6 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: looking for participants now, as of the sponsor's last update on 19 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. 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?
Contact Katherine E. Pickard, PhD (404-7859491, katherine.e.pickard@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Project ImPACT Coaching Fidelity (time frame: Biweekly up to 20 weeks). The study lists 2 primary outcomes in all. 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 19 May 2026.