Improving the Part C Early Intervention Service Delivery System for Children With ASD

Autism Spectrum Disorder Clinical Trial

Official title:

Improving the Part C Early Intervention Service Delivery System for Children With ASD: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114538
• Other study ID #: STUDY00009835
• Secondary ID: 1R01MH122727-01
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: January 2023
• Source: University of Washington
• Contact: Carol A Schubert, MPH
• Phone: 206-543-2823
• Email: schubca[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the critical first three years of life by capitalizing on the existing infrastructure of the Part C Early Intervention (EI) system, which is publicly funded and available in all U.S. States. This project will train EI providers to use an evidence-based, inexpensive, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.

Description:

The long-term goal of this study is to improve services and outcomes for children with early signs of ASD by increasing the capacity to provide appropriately specialized treatment within an existing infrastructure: the Part C Early Intervention (EI) service delivery system. Part C is publicly funded, available throughout the United States, and serves children under age 3 who have developmental delays or disabilities. Currently, the effectiveness of EI services is limited by high practice variation and infrequent use of evidence-based interventions. We are conducting a randomized controlled trial (RCT) to examine the effectiveness of training EI providers to deliver Reciprocal Imitation Training (RIT) to children showing early signs of ASD. RIT is a naturalistic developmental behavioral intervention (NDBI) that is ideally suited for EI settings because it is low intensity, play-based, easy to learn and implement, and can be taught to families for their independent use, thus increasing intervention dosage. This RCT will employ a hybrid type 1 effectiveness/ implementation design and will use a unique mixed methods approach to gather evidence that will be essential for implementing RIT at scale, pending positive trial results. The sample includes 20 EI agencies across 4 U.S. States and comprises a total of 160 EI providers and 440 families of children with early symptoms of ASD, which not only provides a robust sample size, but also affords the opportunity to assess the generalizability of this approach across regions that vary in their implementation of Part C services. EI providers will be randomly assigned to the RIT training group (n=80) or treatment as usual (TAU; n=80). Providers in both groups will identify 2-5 children in their caseload who are 16-30 months old with early symptoms of ASD (n=220 children per group). Intensive, state-of-the art, multimethod assessment technology will be used to measure the impact of the intervention. Child and family assessments will be conducted at baseline, 4 months after enrollment, and 9 months after enrollment. Importantly, this study will examine putative mechanisms through which RIT improves clinically-relevant outcomes. In sum, this study will generate the evidence necessary to implement RIT at scale, thereby increasing the capacity of the existing EI system to deliver effective, evidence-based intervention to the rapidly growing population of children who show early signs of ASD.

Hypotheses:

1. Compared to TAU, children assigned to the RIT group will show more growth from baseline (T1) to the 9-month follow-up (T3) on language and social communication.

2. The impact of RIT on children's social communication and language outcomes at T3 will be mediated by gains in: (a) child joint attention; (b) child motor imitation; (c) parent contingent responsivity, and (d) caregiver fidelity of RIT strategies from baseline (T1) to the 4-month follow-up (T2).

3. Compared to TAU, caregivers assigned to the RIT group will show more improvement in parenting efficacy and family quality of life from baseline (T1) to the 9-month follow-up (T3).

4. The impact of RIT on parenting efficacy and family quality of life at T3 will be mediated by gains in parent contingent responsivity from baseline (T1) to the 4-month follow-up (T2).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Months to 30 Months

Eligibility

Inclusion Criteria:

• parents are biological parents or custodial guardians

• parents are at least 18 years of age

• parents speak either English or Spanish

• the child has a diagnosis of ASD or displays social communication impairments

• The child attends at minimum 1x/week sessions with the enrolled provider

Exclusion Criteria

• the parent or child has previously received RIT or coaching in another NDBI

• the child has visual, hearing, or motor conditions that would compromise his/her ability to participate in RIT or assessments

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Reciprocal Imitation Training
RIT is a relatively straightforward, brief NDBI. It employs four simple strategies to target motor imitation and IJA during play: (1) contingent imitation of the child's verbal and nonverbal behavior, (2) linguistic mapping, (3) direct elicitation of object and gesture imitation following the child's interest, and (4) contingent reinforcement. It has been used at low intensities (e.g., 1-3 hours per week) over short periods of time (e.g., 10-12 weeks) to produce robust changes in pivotal skills. It is easy to learn and can be implemented with fidelity by undergraduate-level therapists with limited backgrounds in ASD, as well as by parents and siblings.

Locations

Country	Name	City	State
United States	University of Massachusetts Boston	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	Michigan State University	East Lansing	Michigan
United States	Carol A Schubert	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
University of Washington	Michigan State University, National Institute of Mental Health (NIMH), Rush University Medical Center, University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parenting Stress Index-Short Form	Parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF) [Moderator]	Baseline
Other	Developmental Play Assessment (DPA	Total number of differentiated acts on toys will be assessed using a virtually-administered version of the Developmental Play Assessment (DPA) [Moderator]	Baseline
Other	Vineland-3	The Adaptive Behavior Composite score will be used to measure child developmental level [Moderator]	Baseline
Primary	Weighted Frequency of Intentional Communication	The Weighted Frequency of Intentional Communication coding protocol will be used to measure expressive communication during a virtual administration of an adapted version of the Communication Play Protocol (CPP; Adamson et al., 2004). [Hypothesis 1]	Change from baseline to 9 months
Primary	Vineland-3	The Communication and Social Domain standard scores from the Vineland-3 will be used to measure child social communication [Hypothesis 1]	Change from baseline to 9 months
Primary	Parenting Efficacy Scale (PES)	The PES Total Score will be used to measure parenting efficacy. [Hypothesis 3]	Change from baseline to 9 months
Primary	Initiation of Joint Attention	An adapted version of the ESCS coding protocol (Roos et al., 2008) will be used to measure initiation of joint attention within a virtual administration of an adapted version of the Communication Play Protocol (CPP; Adamson et al., 2004). [Hypotheses 2; Putative Mechanism/Mediator]	Change from baseline to 4 months
Primary	Unstructured Imitation	An adapted version of the UIA coding protocol (Ingersoll, 2012) will be used to measure spontaneous motor imitation within a virtual administration of an adapted version of the Communication Play Protocol (CPP; Adamson et al., 2004). [Hypotheses 2; Putative Mechanism/Mediator]	Change from baseline to 4 months
Primary	Adapted Motor Imitation Scale (MIS)	Elicited motor imitation will be assessed using a virtually-administered version of the Motor Imitation Scale (MIS). [Hypotheses 2; Putative Mechanism/Mediator]	Change from baseline to 4 months
Primary	The Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)	The PICOOLO coding protocol will be used to measure parent responsivity from parent child interaction videos. [Hypotheses 2 & 4; Putative Mechanism/Mediator]	Change from baseline to 4 months
Primary	RIT Fidelity Form (RIT-FF)	The RIT-FF will be used to measure parent fidelity of the RIT strategies from parent child interaction videos. [Hypothesis 2; Putative Mechanism/Mediator]	Change from baseline to 4 months
Secondary	MacArthur Bates Communicative Development Inventory (MCDI)	The total number of words said on the MCDI will be used to measure expressive vocabulary. [Hypothesis 1]	Change from baseline to 9 months
Secondary	Language Environment Analysis (LENA) Vocal Complexity	Child vocal complexity will be based on recorded language using LENA Software. [Hypothesis 1]	Change from baseline to 9 months
Secondary	Language Environment Analysis (LENA) Vocal Contingency	Child reciprocal vocal contingency will be based on recorded language using the LENA software. [Hypothesis 1]	Change from baseline to 9 months
Secondary	Parent Interview for Autism-Clinical Version (PIA-CV)	Social Communication domains from the PIA-CV will be used to measure child social communication. [Hypothesis 1]	Change from baseline to 9 months
Secondary	Family Life Impairment Scale (FLIS)	The FLIS Total Impairment Score will be used to measure family well-being. [Hypothesis 3]	Change from baseline to 9 months