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

NCT07081724 | Recruiting DMC

• 2 other identifiers: 2401010296A0031R01HD114761-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Autism

Keywords

randomized controlled trial; autism early intervention

Outcome Measures

Primary Outcomes (1)

• Goal Attainment Scaling

  The Goal Attainment Scaling (GAS) is a proximal measure of intervention response, i.e., a measure that captures changes in the specific goals selected for each participant. The GAS is designed to assess an individual's progress on a goal in relation to their baseline performance. The GAS includes standardized procedures to generate a common metric of intervention change across participants who have different intervention goals. For each participant, goals are developed based on areas in which the child is experiencing difficulties (e.g., picky eating, toilet training, self-injurious behavior) that caregivers want to address by teaching specific skills. Videos provided by the caregivers at pre- and post- intervention are rated according to the GAS standard procedures on a 5-point scale, whereby positive changes in score from baseline indicating increasingly positive benchmarks of improvement from the baseline to post-intervention.

  Within 30 days from consent

Secondary Outcomes (3)

• Vineland Scales of Adaptive Behavior-3

  Within 30 days from consent

• Parenting Stress Index-4, Short-Form

  Within 30 days from consent

• Autism Impact Measure (AIM)

  Within 30 days from consent

Other Outcomes (2)

• Acceptability of Intervention Measure

  Within 14 days of intervention completion (approximately 6 months from intervention start)

• Feasibility of Intervention Measure

  Within 14 days of intervention completion within 14 days of intervention completion (approximately 6 months from intervention start)

Study Arms (2)

OPT-IN intervention

EXPERIMENTAL

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.

Behavioral: Online Parent Training in Early Behavioral Intervention (OPT-In-Early)

Waitlist

NO INTERVENTION

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.

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.

OPT-IN intervention

Eligibility Criteria

• Age: 16 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 16-48 months,
• parental consent
• being on a waitlist to receive a formal diagnostic evaluation at the time of parent consent due to autism concerns
• parents speak English
• an initial score of 8 or greater or Follow-Up score of 2 or greater on the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (M-CHAT-R/F; Robins et al., 2014) as an indication of autism likelihood.

You may not qualify if:

• having already received a formal diagnosis of autism
• enrollment in early intervention programs delivering more than 5 h per week of evidence-based autism-specific interventions at the time of consent
• child has a gestational age less than 36 weeks associated with a birth weight less than 2500 g
• the child is not yet walking, or has severe hearing and/or vision impairment that is uncorrected with aids, or known neurological disorder or genetic syndrome (e.g., Down syndrome).

Sponsors & Collaborators

• Drexel University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

A.J. Drexel Autism Institute

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• Ruble L, McGrew JH, Toland MD. Goal attainment scaling as an outcome measure in randomized controlled trials of psychosocial interventions in autism. J Autism Dev Disord. 2012 Sep;42(9):1974-83. doi: 10.1007/s10803-012-1446-7.

  PMID: 22271197 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: post-intervention outcomes will be assessed by clinicians who will be blind to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 23, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)