Autism Spectrum Disorder
Conditions
Keywords
Consultation, Autism Spectrum Disorder, Medicaid, Parent-mediated intervention, Parent Training
Brief summary
Parent-mediated interventions are considered best practice for treating children with autism spectrum disorder, but these interventions are underutilized in community settings. Implementation strategies like consultation can improve the implementation of these interventions, but little is known about the active ingredients of consultation. This study uses an experimental design (ABCD single-case design with multiple baselines) to identify the active ingredients of a consultation model designed to support the implementation of a parent-mediated intervention for autism spectrum disorder in a low-resourced community mental health system.
Detailed description
There are multiple evidence-based practices (EBPs) to treat autism spectrum disorder (ASD), yet the gap from when EBPs are developed to when they reach community settings is 17 years. EBPs are consistently underused in community settings despite their well-studied effectiveness. One such EBP for treating ASD in young children is parent-mediated intervention. Consultation is one method of supporting implementation that involves providing clinicians with support and feedback from intervention experts. For this study, consultation on an evidence-based parent-mediated intervention, Project ImPACT, will be the focus. Understanding the active ingredients that go into consultation is important to understand how consultation works so that it can be tailored to best meet the needs of community settings. This single-case experimental design (SCED) will manipulate three potential ingredients of consultation: feedback on taped sessions, case support, and skill rehearsal. Groups of 3-5 providers per agency will be given 2 weeks to complete a 6-hour self-directed online tutorial on Project ImPACT utilized regularly by Project ImPACT consultants. Next, each agency will be randomly assigned to baselines lasting 3-6 weeks, followed by 4 weeks of each consultation component (total of 12 weeks). All agencies will receive consultation. The order of the consultation components will be randomized using a random number generator such that each agency has an equal chance of receiving one of the predetermined permutations of phases which are labeled in alphabetical order (e.g., equally as likely to be randomized to ABCD order as ADBC order). Across each phase, providers will record one session per week with their enrolled family and submit it via a HIPAA-compliant Drop-box link. Providers will complete weekly online questionnaires on implementation outcomes, with time reserved during consultation sessions to complete them. After consultation, providers will submit a final recorded session and questionnaire 8-weeks post-consultation. Caregivers will complete a measure of social communication for their child via online questionnaire at baseline, twice during consultation, and after 8 weeks post-consultation. The feedback phase will involve the consultant and peers responding to the 5-minute clips of recorded telehealth sessions with praise and constructive feedback. The case support phase will be a time for the consultant and peers to assist in any challenges faced; for example, this could include issues with telehealth, caregiver coaching, or family/child needs. The skill rehearsal phase will allow for consultees to practice their clinical skills via role play. This study will have 4 aims: Specific Aim 1: Identify the potential active ingredients of the consultation model by evaluating its effects on providers' treatment adherence and parent-mediated intervention competence. The investigators predict that the feedback component will improve adherence and competence over and above improvements from the case support and skill rehearsal components. Specific Aim 2: Examine the relative feasibility, acceptability, and appropriateness of each consultation component using a SCED component analysis. Feasibility is the extent to which a practice can be successfully carried out within a setting. Acceptability is the extent to which a practice is agreeable and satisfactory. Appropriateness is the perceived fit or relevance of a practice to address a problem. The investigators predict that providers will perceive the case support component to be the most feasible, acceptable, and appropriate of all components. Specific Aim 3: Examine the effects of the consultation model on case penetration and the feasibility, acceptability, and appropriateness of the EBP (Project ImPACT). The investigators predict case penetration (i.e., total number of Project ImPACT cases on a provider's caseload divided by the total number of eligible clients) and EBP feasibility, acceptability, and appropriateness to increase over time. Exploratory Aim 4: Demonstrate associated social communication outcomes for Medicaid-enrolled children with ASD from baseline to post-consultation. Given that consultation leads to improved adherence and child outcomes and Project ImPACT results in improved child social communication outcomes, the investigators predict that our consultation model will be associated with improvements in child social communication skills.
Interventions
OTHERConsultee-centered administrative consultation
The consultee-centered administrative consultation model expressly focuses on supporting providers to increase EBP implementation within their specific setting.
Sponsors
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Groups of 3-5 providers will be recruited from four applied behavior analysis (ABA) agencies (\ 20 providers in total) that contract with regional community mental health agencies to provide ABA services to Medicaid-enrolled children with autism spectrum disorder (ASD). Families on the providers' caseloads will be enrolled. Inclusion Criteria for Providers: • Have at least one caregiver on their caseload who would be appropriate for Project ImPACT and who agrees to enroll in the study and have their sessions recorded.
Exclusion criteria
for Providers: * Not qualified to bill for ABA services through the Medicaid Autism Benefit. * Under age 18 Inclusion Criteria for Caregivers: * Parent or guardian of a child who has a community diagnosis of ASD established using the Autism Diagnostic Observation Schedule (a gold standard ASD assessment), receives services through the Medicaid Autism Benefit (requires a household income at or below 133% of the federal poverty line), is between the ages of 18 months and 6 years, which is the age range targeted for Project ImPACT, and has at least 1 session per week with the provider. * Child's provider is enrolled in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Adherence | 23-26 weeks | 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. |
| Parent-mediated Intervention Competence | 23-26 weeks | 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. |
| Case Penetration | 23-26 weeks | 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. |
| Ratings of the Usability of Each Consultation Component | 23-26 weeks | 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. |
| Ratings of Perceptions of Project ImPACT | 23-26 weeks | 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. |
| Child Social Communication Skills | 23-26 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 21 |
| Total | 41 |
Baseline characteristics
| Characteristic | Provider Treatment (Consultation) | Family Treatment (Project ImPACT) | Total |
|---|---|---|---|
| Age, Continuous | 32 years | 36 years | 35 years |
| Autism Impact Measure | — | 234.76 units on a scale | 234.76 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 19 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| PEACE Parent Coaching Competency Fidelity | 2.87 units on a scale | — | 2.87 units on a scale |
| Project ImPACT Coaching Fidelity | 62.51 units on a scale | — | 62.51 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 20 Participants | 14 Participants | 34 Participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Case Penetration
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Providers | Case Penetration | 24.37 percentage of caseload | Standard Error 4.48 |
p-value: <0.05multilevel modeling
Primary
Child Social Communication Skills
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Providers | Child Social Communication Skills | 40.09 score on a scale | Standard Error 2.7 |
p-value: <0.05multilevel model
Primary
Parent-mediated Intervention Competence
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.
Time frame: 23-26 weeks
Population: This measure is only collected from the provider arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Providers | Parent-mediated Intervention Competence | 2.87 score on a scale | Standard Error 0.11 |
p-value: <0.05multilevel model
Primary
Ratings of Perceptions of Project ImPACT
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.
Time frame: 23-26 weeks
Population: This measure is only collected from the provider arm. 286 surveys from 18 clinicians with sufficient data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Providers | Ratings of Perceptions of Project ImPACT | 3.38 score on a scale | Standard Error 0.18 |
p-value: <0.05multilevel model
Primary
Ratings of the 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.
Time frame: 23-26 weeks
Population: This measure is only collected from the provider arm. 20 clinicians reported on usability of each consultation component.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Providers | Ratings of the Usability of Each Consultation Component | Case Support | 76.78 score on a scale | Standard Deviation 14.12 |
| Providers | Ratings of the Usability of Each Consultation Component | Skill Rehearsal | 60.71 score on a scale | Standard Deviation 15.99 |
| Providers | Ratings of the Usability of Each Consultation Component | Feedback on Videotaped Sessions | 72.01 score on a scale | Standard Deviation 15.37 |
p-value: <0.05ANOVA
Primary
Treatment Adherence
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.
Time frame: 23-26 weeks
Population: This measure is only collected from the provider arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Providers | Treatment Adherence | 62.51 score on a scale | Standard Error 5.08 |
p-value: <0.05multilevel model