"Opt-In" Early Intervention Program for Children Waiting to Receive an Autism Diagnosis

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Drexel University
Study ID
NCT07081724
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Months - 48 Months
Healthy Volunteers
Not accepted

Interventions

  • Online Parent Training in Early Behavioral Intervention (OPT-In-Early) — BEHAVIORAL
    the "Online Parent Training in Early Behavioral Intervention" (OPT-In-Early; Dai et al., 2018, 2021,2022) is a self-directed online resource for caregivers of children with autism or high likelihood of autism. The OPT-In-Early program includes 14 modules (6 mandatory, 8 optional) comprising text and video demonstrations to teach caregivers effective methods for improving their children's language, social, and adaptive skills (e.g., using utensils, toilet training), and reducing their children's disruptive behavior. Parents are taught how to facilitate joint attention, imitation, pretend play, language, sharing, emotional engagement, social play, and self-help skills such as feeding and dressing in their child using behavioral principles (e.g. prompting, shaping and fading) during play and naturalistic daily routines. The optional modules cover such topics as picky eating and toilet training.

Study Details

A growing body of literature documents the benefits of parent-mediated interventions for autism starting early in life . However, the median age of diagnosis in the US continues to be 49 months. Even following formal diagnosis, services often do not begin for another 9 months on average. Such harmful delays in accessing autism-specific early interventions are potentially avoidable, as caregivers of children later diagnosed with autism identify concerns about their child's development by 13 months on average - including difficulties that can be successfully addressed through evidence-based intervention practices. Wait times to receive a formal diagnosis of autism are such a significant barrier that they have been referred to as a "crisis" in the field, with parents reporting an average wait time of 1.2 years in the US. The current proposal focuses on circumventing the roadblock of delayed access to diagnosis and intervention by empowering caregivers to address their children's needs before a diagnosis is established. This will be accomplished through the implementation and evaluation of the "Online Parent Training in Early Behavioral Intervention (OPT-In-Early)", a self-directed online resource for caregivers of autistic children which will be made available during their enrollment in waitlists for a diagnostic evaluation. Key features of OPT-In-Early include: (a) a comprehensive scope (i.e., multiple developmental domains are addressed), (b) a focus on evidence-based Naturalistic Developmental Behavioral Intervention strategies, (c) a combination of required and optional modules, so that caregivers can focus on areas most relevant to their child's needs, and (d) access to online materials designed for self-directed implementation, as well as access to remote consultation with a clinician for advice, clarification and support (including on selection of appropriate modules). Following an alternative approach to the current "parental concerns - then enrollment in waitlist - then clinical diagnosis - then intervention", the program is designed to counteract the harmful and frustrating inaction that characterizes the waitlist time with timely action designed to address areas of concern that caregivers have already identified and should be empowered to address. This has the potential to capitalize on the window of opportunity of early brain plasticity, thus maximizing outcomes, and to reduce the anxiety associated with the lack of services that characterizes the period of "passive waiting" for a formal diagnosis. To evaluate the utility of this innovative resource, the following specific aims will be addressed: 1. Comparing outcomes for 120 toddlers aged 16-48 months whose caregivers are on a waitlist to receive a formal autism diagnosis, randomly assigned to receive either OPT-In-Early or no intervention during a six-month period. The investigators predict that (a) children randomized to the OPT-In-Early condition will have superior gains as reflected in the Goal Attainment Scaling, changes in adaptive behavior and social communication standardized measures, and (b) their families will experience superior improvements in their well-being. 2. Examining implementation outcomes of feasibility and acceptability of the intervention. The investigators predict high acceptability and feasibility for the OPT-In-Early content and format, as indicated by end-users' responses to standardized measures reflecting 80%+ agreement on the feasibility and acceptability of the program. 3. As an exploratory aim, investigators will examine theoretically- and empirically- motivated factors associated with intervention uptake and child outcomes, including demographic profiles and child clinical presentation. Examining whether accessing and using OPT-In-Early during waitlist time is a viable alternative to the current "first diagnosis then intervention" format (for all children, or for children with specific profiles and needs) is a critical step toward promoting a more efficient intervention delivery model, bridging the gap between onset of parental concerns and availability of intervention practices designed to target such concerns.

Key Dates

Start date
Aug 25, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OPT-IN intervention
    Participants randomized to the experimental condition will be given access to the the "Online Parent Training in Early Behavioral Intervention" (OPT-In-Early; Dai et al., 2018, 2021,2022), a self-directed online resource for caregivers of children with autism or high likelihood of autism. The OPT-In-Early program includes 14 modules (6 mandatory, 8 optional) comprising text and video demonstrations to teach caregivers effective methods for improving their children's language, social, and adaptive skills (e.g., using utensils, toilet training), and reducing their children's disruptive behavior. Parents in the OPT-In-Early condition will be also offered the option to schedule brief support calls with a clinician for the duration of the 6-month trial, with a limit of three calls per week. These optional support calls are designed to provide parents with clarification and guidance on how to navigate the website materials, including selection of the appropriate modules.
  • No Intervention: Waitlist
    Child-parent dyads randomly assigned to the waitlist group will not receive immediate access to the OPT-In intervention or any other intervention. However, after 6 month (equivalent to the the 6-month intervention period) they will be given access to the OPT-In intervention. However, outcomes will not be measured for these participants.

Primary Outcome Measure

Goal Attainment Scaling [ Time Frame: Within 30 days from consent ]

Locations (1)

FacilityCityStateZIPSite coordinators
A.J. Drexel Autism InstitutePhiladelphiaPennsylvania19104
Giacomo Vivanti, PhD
[email protected]
215-571-3202

Find similar trials in Philadelphia, PA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
A.J. Drexel Autism Institute· Philadelphia, PA

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