Trial Outcomes & Findings for Examining the Active Ingredients of Consultation of a Parent-mediated Intervention for Autism (NCT NCT04654117)

Last Updated: 2025-04-03

Results Overview

The Project ImPACT Coaching Fidelity Checklist is a measure of treatment adherence. It uses a 3-point scale -- Observed (1), Partially Observed (.5), and Not Observed (0). Higher scores indicate higher treatment adherence. Based on scoring guidelines for this measure, scores for each item are multiplied by an item-specific weight value. Scores for each item are then summed and divided by the total number of items scored, yielding a score ranging from 0 to 100.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

23-26 weeks

Results posted on

2025-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Provider Treatment (Consultation) All providers received consultation. Consultation was conducted in 4-week phases that correspond to the three consultation components: Case Support, Feedback, and Skill Rehearsal. The phases will occur in a randomized order. During a given phase, no components of any other phases were provided. Feedback phase. Consultees submitted 5-minute clips of session recordings of their Project ImPACT session with their enrolled family for feedback. Oral feedback was provided by the consultant and peers. Case support phase. The consultant led the group in problem-solving common barriers that providers experience with their cases. Skill rehearsal phase. The consultant led skill rehearsal practices in which providers role played elements of a Project ImPACT session.	Family Treatment (Project ImPACT) All families received Project ImPACT. Project ImPACT is an evidence-based manualized parent coaching program that is designed to teach caregivers strategies to support social communication development in young children with autism or social communication delays. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI), which is a newer class of autism intervention that blends principles of developmental science and applied behavior analysis (Schreibman et al., 2015). Clinicians were instructed to deliver the Project ImPACT program once per week via a telehealth platform supported by their agency (e.g., Zoom, HIPAA-compliant Google Meet), for a total of 24 sessions, with a session length of 60 minutes per session.
Overall Study STARTED	20	21
Overall Study COMPLETED	16	13
Overall Study NOT COMPLETED	4	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 caregivers had missing data for sex.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 23-26 weeks

Population: This measure is only collected from the provider arm.

Outcome measures

Outcome measures
Measure	Providers n=12 Participants Al providers in the study submitted telehealth sessions and a series of questionnaires.
Treatment Adherence	62.51 score on a scale Standard Error 5.08

PRIMARY outcome

Timeframe: 23-26 weeks

Population: This measure is only collected from the provider arm.

Parent-mediated intervention competence will be assessed via Parent Empowerment and Coaching in Early Intervention (PEACE) coding which utilizes a 5-point scale to assess for competency in delivering collaborative coaching techniques used in parent-mediated interventions. The scale used is: Never (1), Rarely (2), Sometimes (3), Often (4), and Almost Always (5). The minimum value on the scale is 1 and the maximum is 5. Higher scores indicate higher parent-mediated intervention competence.

Outcome measures

Outcome measures
Measure	Providers n=12 Participants Al providers in the study submitted telehealth sessions and a series of questionnaires.
Parent-mediated Intervention Competence	2.87 score on a scale Standard Error 0.11

PRIMARY outcome

Timeframe: 23-26 weeks

Population: This measure is only collected from the provider arm. 288 observations (i.e., surveys) across 20 clinicians from 6 agencies were included in the models.

Case penetration will be measured weekly using the Penetrability Formula and will be expressed using provider report of the total number of Project ImPACT cases on their caseload divided by the total number of eligible clients with ASD on their Medicaid Autism Benefit caseload. This is expressed as a percentage. Higher percentage values indicate higher case penetration.

Outcome measures

Outcome measures
Measure	Providers n=20 Participants Al providers in the study submitted telehealth sessions and a series of questionnaires.
Case Penetration	24.37 percentage of caseload Standard Error 4.48

PRIMARY outcome

Timeframe: 23-26 weeks

Population: This measure is only collected from the provider arm. 20 clinicians reported on usability of each consultation component.

Clinicians reported on the usability of each consultation component weekly across the 4 weeks of each consultation condition using the Implementation Strategy Usability Scale (Lyon et al., 2021). This 10-item questionnaire uses a 5-point Likert scale to examine clinician perceptions about the complexity of using an implementation strategy. The scale is unidimensional and has no subscales. Based on scoring guidelines, a formula is used to calculate the total usability score, which ranges from 0-100. Higher scores indicate higher usability; higher scores indicate higher ratings of the participant's ability to use the strategy with ease. The formula involves the following: for each odd numbered item, subtract 1 from the Likert rating value to get the new value; for each even numbered item, subtract the Likert rating value from 5 to get a new value; then sum all new values and multiply by 2.5.

Outcome measures

Outcome measures
Measure	Providers n=20 Participants Al providers in the study submitted telehealth sessions and a series of questionnaires.
Ratings of the Usability of Each Consultation Component Case Support	76.78 score on a scale Standard Deviation 14.12
Ratings of the Usability of Each Consultation Component Skill Rehearsal	60.71 score on a scale Standard Deviation 15.99
Ratings of the Usability of Each Consultation Component Feedback on Videotaped Sessions	72.01 score on a scale Standard Deviation 15.37

PRIMARY outcome

Timeframe: 23-26 weeks

Population: This measure is only collected from the provider arm. 286 surveys from 18 clinicians with sufficient data.

Providers completed the Perceived Characteristics of Intervention Scale (PCIS; Cook et al., 2015) weekly about their perceptions of Project ImPACT. This 18-item questionnaire includes items related to various constructs from Rogers' Diffusions of Innovation theory (Rogers, 2010). All items are rated on a 7-point Likert scale and the overall PCIS score is established by computing the mean of all items. The minimum score is 1.00 and maximum is 7.00. Higher values indicate more positive perceptions of the intervention.

Outcome measures

Outcome measures
Measure	Providers n=18 Participants Al providers in the study submitted telehealth sessions and a series of questionnaires.
Ratings of Perceptions of Project ImPACT	3.38 score on a scale Standard Error 0.18

PRIMARY outcome

Timeframe: 23-26 weeks

Population: This measure is only collected from the caregiver arm (caregivers reporting on child skills). Models included 62 surveys across 17 children from 5 agencies.

The Autism Impact Measure has 41 items rated on a 5-point scale ranging from Never (1) to Always (5). The overall score is calculated by summing the scores on two scales (frequency and impact). Higher values indicate a higher frequency and impact of autism-related concerns child functioning. The minimum value is 82 and the maximum value is 410.

Outcome measures

Outcome measures
Measure	Providers n=17 Participants Al providers in the study submitted telehealth sessions and a series of questionnaires.
Child Social Communication Skills	40.09 score on a scale Standard Error 2.70

Adverse Events

Provider Treatment (Consultation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Family Treatment (Project ImPACT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brooke Ingersoll, Professor

Department of Psychology, Michigan State University

Phone: 517-432-8412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Provider Treatment (Consultation) n=20 Participants All providers received consultation. Consultation was conducted in 4-week phases that correspond to the three consultation components: Case Support, Feedback, and Skill Rehearsal. The phases will occur in a randomized order. During a given phase, no components of any other phases were provided. Feedback phase. Consultees submitted 5-minute clips of session recordings of their Project ImPACT session with their enrolled family for feedback. Oral feedback was provided by the consultant and peers. Case support phase. The consultant led the group in problem-solving common barriers that providers experience with their cases. Skill rehearsal phase. The consultant led skill rehearsal practices in which providers role played elements of a Project ImPACT session.	Family Treatment (Project ImPACT) n=21 Participants All families received Project ImPACT. Project ImPACT is an evidence-based manualized parent coaching program that is designed to teach caregivers strategies to support social communication development in young children with autism or social communication delays. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI), which is a newer class of autism intervention that blends principles of developmental science and applied behavior analysis (Schreibman et al., 2015). Clinicians were instructed to deliver the Project ImPACT program once per week via a telehealth platform supported by their agency (e.g., Zoom, HIPAA-compliant Google Meet), for a total of 24 sessions, with a session length of 60 minutes per session.	Total n=41 Participants Total of all reporting groups
Age, Continuous	32 years n=20 Participants	36 years n=21 Participants	35 years n=41 Participants
Sex: Female, Male Female	18 Participants n=20 Participants • 2 caregivers had missing data for sex.	17 Participants n=19 Participants • 2 caregivers had missing data for sex.	35 Participants n=39 Participants • 2 caregivers had missing data for sex.
Sex: Female, Male Male	2 Participants n=20 Participants • 2 caregivers had missing data for sex.	2 Participants n=19 Participants • 2 caregivers had missing data for sex.	4 Participants n=39 Participants • 2 caregivers had missing data for sex.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants • 2 caregivers had missing data for ethnicity.	0 Participants n=21 Participants • 2 caregivers had missing data for ethnicity.	0 Participants n=41 Participants • 2 caregivers had missing data for ethnicity.
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=20 Participants • 2 caregivers had missing data for ethnicity.	19 Participants n=21 Participants • 2 caregivers had missing data for ethnicity.	39 Participants n=41 Participants • 2 caregivers had missing data for ethnicity.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants • 2 caregivers had missing data for ethnicity.	2 Participants n=21 Participants • 2 caregivers had missing data for ethnicity.	2 Participants n=41 Participants • 2 caregivers had missing data for ethnicity.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants • 2 caregivers had missing data for race.	0 Participants n=21 Participants • 2 caregivers had missing data for race.	0 Participants n=41 Participants • 2 caregivers had missing data for race.
Race (NIH/OMB) Asian	0 Participants n=20 Participants • 2 caregivers had missing data for race.	0 Participants n=21 Participants • 2 caregivers had missing data for race.	0 Participants n=41 Participants • 2 caregivers had missing data for race.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants • 2 caregivers had missing data for race.	0 Participants n=21 Participants • 2 caregivers had missing data for race.	0 Participants n=41 Participants • 2 caregivers had missing data for race.
Race (NIH/OMB) Black or African American	0 Participants n=20 Participants • 2 caregivers had missing data for race.	4 Participants n=21 Participants • 2 caregivers had missing data for race.	4 Participants n=41 Participants • 2 caregivers had missing data for race.
Race (NIH/OMB) White	20 Participants n=20 Participants • 2 caregivers had missing data for race.	14 Participants n=21 Participants • 2 caregivers had missing data for race.	34 Participants n=41 Participants • 2 caregivers had missing data for race.
Race (NIH/OMB) More than one race	0 Participants n=20 Participants • 2 caregivers had missing data for race.	1 Participants n=21 Participants • 2 caregivers had missing data for race.	1 Participants n=41 Participants • 2 caregivers had missing data for race.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants • 2 caregivers had missing data for race.	2 Participants n=21 Participants • 2 caregivers had missing data for race.	2 Participants n=41 Participants • 2 caregivers had missing data for race.
Project ImPACT Coaching Fidelity	62.51 units on a scale n=20 Participants • This measure is only for providers and refers to their fidelity to using Project ImPACT.	—	62.51 units on a scale n=20 Participants • This measure is only for providers and refers to their fidelity to using Project ImPACT.
PEACE Parent Coaching Competency Fidelity	2.87 units on a scale n=20 Participants • This measure is only completed for providers, as it is a measure of competency in delivering parent coaching interventions.	—	2.87 units on a scale n=20 Participants • This measure is only completed for providers, as it is a measure of competency in delivering parent coaching interventions.
Autism Impact Measure	—	234.76 units on a scale n=21 Participants • This measure was only for caregivers as it is a caregiver-report questionnaire of child skills.	234.76 units on a scale n=21 Participants • This measure was only for caregivers as it is a caregiver-report questionnaire of child skills.