Opt-In Early Pilot Study

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT06908187
• Lead Sponsor: Oregon Health and Science University

Brief Summary

Latinx and Rural-living children with diagnosed or suspected autism have especially long wait times for diagnoses and intervention, up to a year or even more. This delayed access to intervention is likely to prevent children from reaching their full potential in skills and adaptive functioning. A comprehensive, online mobile device-based, free intervention that can be used by parents while on these wait lists may optimize their child's development. The investigators have developed such a program, the Online Parent Training in Early Intervention (OPT-In-Early) program. It teaches parents the fundamental principles of both applied behavior analysis and naturalistic interventions, uses non-technical language, video demonstrations, guidance in selecting appropriate skills to teach, embedding teaching into daily routines, and reducing interfering behaviors. It is a self-paced, individualized platform giving parents strategies to strengthen the parent-child relationship, to teach basic skills, such as simple communication, to reduce interfering behaviors, and to establish helpful routines. In pilot the RCT, parents (half of whom were self-identified as Latinx) rated the program very highly and showed positive changes in behavior and knowledge. The goal of the current project is to develop, and pilot test a bilingual Spanish/English culturally tailored version of OPT-In-Early for Latinx families in the US, as well as tailoring and testing the program for rural communities of Oregon. First, the investigators will obtain detailed, iterative feedback from bilingual Latinx parents with an autistic child regarding OPT-In-Early. Similar feedback will also be obtained from participants from rural communities of Oregon who also have an autistic child. The investigators will use this feedback to culturally adapt the program content and format. Next, the adapted program will be modified via user testing with Spanish speaking parents and English speaking parents. Finally, the bilingual version will be tested in a six-month pilot RCT, in preparation for a fully powered R01 trial. The investigators will use a wait-list control design: the Intervention Now arm will be given the online program and the Intervention Later arm (controls) will be given educational material about autism. All children will receive a baseline and 6-month follow-up assessment, which will measure parent fidelity in using the intervention principles (the primary outcome), child social communication, level of autism symptoms, impact of autism symptoms, and degree of developmental delays. The Intervention Now group will have two subgroups. One will test the online program with an emphasis placed on the Spanish version, while the other will focus on the English version and complete the program through a rural lens. At the conclusion of this research, the investigators will have developed an evidence-based, comprehensive, freely available, parent-delivered intervention that can be used by US Latinx and rural families on their mobile devices as they await diagnosis and intervention. This will increase parent efficacy and reduce their stress, accelerate children's skills, reduce interfering behavior, and enhance PCPs' willingness to implement universal autism screening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-14
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Study Start: 2025-12
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Parent-child dyads where the child has a definitive or provisional diagnosis of autism
• Children must be aged 15 - 42 months
• Latinx arm parents must be primarily Spanish-speaking or balanced bilinguals
• Rural arm participants would ideally reside in primarily rural communities (identified with RUCA codes; RUCA score >5)

Exclusion Criteria

• Diagnosed with another major developmental condition (e.g., Down Syndrome, Hearing Impairment)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Social Interaction Rating Scale (SIRS)	It is administered pre- and post-six months of intervention to both groups.	It is a measure of observed parent use of intervention strategies, to assess Parent Fidelity. This is observational measure is videotaped and coded by a trained rater blind to group. Parents are asked to do 4 activities with their child, keeping the child as engaged as possible: (1) Work on a puzzle (2) Teach your child to imitate you doing a simple behavior that you haven't already taught them to imitate; (3) Play with your child using bubbles. (4) Feed your child a snack. Each activity is recorded for 3 minutes. Parents' responsivity to the child based on behavioral and affective principles emphasized throughout OPT-In- Early are coded: positive affect, contingent reinforcement, appropriate directiveness, promotion of eye contact, and appropriate level of prompting. Each item is scored on a 5-point Likert scale Scores on the 5 items are also summed to yield a total score. OPT-In-Early pilot data demonstrated good-to-excellent ICC's for between-rater reliability for these SIRS items.

Secondary Outcome Measures

Name	Time	Method
Autism Impact Measure (AIM)	Once at baseline evaluation and a second at the end of the six months of intervention.	It is a parent rating of core autism symptom. The AIM is one of few autism measures designed specifically to assess change in core symptoms due to treatment, and is sensitive to change over short-term treatment. For each symptom or developmental milestone listed, the parent indicates the frequency of the behavior and the impact that the parent thinks it has on the child's everyday functioning Western Psychological Services (the publisher) has already translated this instrument into Spanish. We are applying for permission to use this as a research instrument to WPS. . Improvement in child core autism symptoms will be assessed via changes in parent ratings of frequency and impact on functioning between the two administrations, the first at the baseline evaluation and the second at the end of the six months of intervention
Brief Observation of Social Communication Change (BOSCC)	It is administered at the baseline evaluation and after the six months of intervention or psycho-education.	Change in child social communication is assessed via direct observation with the BOSCC, which detects subtle and short term changes in child social communication, unlike instruments that were primarily designed for diagnosis and may not be sensitive to short term or smaller changes (e.g., ADOS-2, BOSA, Tele-ASD-Peds). Furthermore, it can be administered by parents with RA instruction (not requiring a research reliable clinician) with a standard toy set. It is being used with guidance from the authors, in our just concluded NIH-funded ACE Connect the Dots study (Robins, PI, NICHD: 1R01MH115715); we are ready to have the RAs instruct the parents in the simple social presses and to bring a sanitized toy set to the assessment sessions. The authors have outlined procedures by which the very general parent instructions can be translated into parents' first language. BOSCC sessions, which are about 12 minutes long, are videotaped and coded by a trained RA blind to group.
Early Intervention Parenting Self-Efficacy Scale (EIPSES)	Responses are averaged across items to produce a single parenting self-efficacy score at the baseline evaluation and at the six month post-treatment evaluation.	This a brief self-report measure of parents' perceptions of their parenting competence, and their ability to contribute to intervention outcomes for their children. The EIPSES has good internal consistency and adequate convergent validity (Guimond et al., 2008). A few Items were modified slightly by study investigators to be applicable to an intervention delivered to young children by caregivers. Senior author of the scale (Jeanne Wilcox, Prof. Emerita, ASU) gave us permission to translate the scale into Spanish.
Parenting Stress Index (PSI-4)	It is administered at the baseline evaluation and at the six month post-treatment evaluation.	This index assesses parent stress; it is composed of 36 items, over 3 domains: Parental Distress, Parent Child Dysfunctional Interaction, and Difficult Child, which combine to form a Total Stress scale. The publisher has made the PSI available in Spanish.

Trial Locations

Locations (2)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States