Opt-In Early Pilot Study

NCT06908187 | Not Yet Recruiting

• 3 other identifiers: STUDY00025956R34MH132712no number
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Social Interaction Rating Scale (SIRS)

  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.

  It is administered pre- and post-six months of intervention to both groups.

Secondary Outcomes (4)

• Autism Impact Measure (AIM)

  Once at baseline evaluation and a 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.

• 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.

• Parenting Stress Index (PSI-4)

  It is administered at the baseline evaluation and at the six month post-treatment evaluation.

Other Outcomes (8)

• Treatment Evaluation Inventory - Short Form (TEI-SF)

  It will be administered to parents in the intervention group after they have 6-month access to the material.

• System Usability Scale (SUS)

  Completed at the end of the intervention.

• Intervention Uptake via Usage Diary

  Multiple times throughout intervention.

Study Arms (3)

Intervention Now - Latinx

EXPERIMENTAL

Families assigned to the Intervention Now group will receive the Opt-in Early online curriculum/website in their preferred language(s). Opt-in Early is a self-directed parent-training program targeting cognitive, language, social, and adaptive behaviors in children with new or suspected autism diagnoses. It is a mobile-device compatible website that can be accessed on any smart phone, tablet, or PC. The program is designed to bridge the time between when autism is first identified and when a child accesses more definitive services. It can also be used by parents who do not desire, or who cannot access in-person services. The program is publicly available and has 6 core modules and 6 optional modules, each of which takes \~1 hour to complete, as well as a detailed resource guide. It can be offered by primary care practices, autism specialty clinics, and educational programs, and requires minimal family support.

Other: Opt-In Early Latinx intervention

Intervention Later (Control)

NO INTERVENTION

Families randomized to Intervention Later (control arm) will be offered (a) viewing of a 7-minute English or Spanish Youtube video about autism evaluation and treatment options (b) print educational materials (5th-grade reading level) about developmental delays, the meaning of screening positive for possible autism, and how to navigate the Early Intervention system in their state (Oregon or Connecticut), and (c) English or Spanish versions of the Autism Speaks First Concerns to Action Kit.

Intervention Now - Rural

EXPERIMENTAL

Families assigned to the Intervention Now group will receive the Opt-in Early online curriculum/website in their preferred language(s). Opt-in Early is a self-directed parent-training program targeting cognitive, language, social, and adaptive behaviors in children with new or suspected autism diagnoses. It is a mobile-device compatible website that can be accessed on any smart phone, tablet, or PC. The program is designed to bridge the time between when autism is first identified and when a child accesses more definitive services. It can also be used by parents who do not desire, or who cannot access in-person services. The program is publicly available and has 6 core modules and 6 optional modules, each of which takes \~1 hour to complete, as well as a detailed resource guide. It can be offered by primary care practices, autism specialty clinics, and educational programs, and requires minimal family support.

Other: Opt-In Early Rural Intervention

Interventions

Opt-In Early Latinx intervention OTHER

Participants will access to the Opt-In Early training program website, but will be able to access the Spanish language version as well. Families will fill out a usage diary to record their experience.

Intervention Now - Latinx

Opt-In Early Rural Intervention OTHER

Participants will access to the Opt-In Early training program website. Parents will be able to interact with the rural community-oriented aspects of the program. Families will fill out a usage diary to record their experience.

Intervention Now - Rural

Eligibility Criteria

• Age: 15 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute of Mental Health (NIMH): collaborator
• Connecticut Children's Medical Center: collaborator
• University of Connecticut: collaborator
• University of Texas at Austin: collaborator

Study Sites (2)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (15)

• Ruble, L., McDuffie, A., King, A. S., & Lorenz, D. (2008). Caregiver responsiveness and social interaction behaviors of young children with autism. Topics in Early Childhood Special Education, 28(3), 158-170

  BACKGROUND

• Nielsen J. Usability Engineering. San Diego, CA: Academic Press; 1993.

  BACKGROUND

• Mazurek MO, Carlson C, Baker-Ericzen M, Butter E, Norris M, Kanne S. Construct Validity of the Autism Impact Measure (AIM). J Autism Dev Disord. 2020 Jul;50(7):2307-2319. doi: 10.1007/s10803-018-3462-8.

  PMID: 29344761 BACKGROUND

• Mazurek MO, Carlson C, Baker-Ericzen M, Butter E, Norris M, Barr C, Kanne S. The Autism Impact Measure (AIM): Examination of Sensitivity to Change. Autism Res. 2020 Nov;13(11):1867-1879. doi: 10.1002/aur.2397. Epub 2020 Oct 1.

  PMID: 33001561 BACKGROUND

• Kelley, M. L., Hefer, R. W., Gresham, F. M., & Elliott, S. N. (1989). Development of a modified treatment evaluation inventory. Journal of Psychopathology and Behavioral Assessment, 11(3), 235-247.

  BACKGROUND

• Kanne SM, Mazurek MO, Sikora D, Bellando J, Branum-Martin L, Handen B, Katz T, Freedman B, Powell MP, Warren Z. The Autism Impact Measure (AIM): initial development of a new tool for treatment outcome measurement. J Autism Dev Disord. 2014 Jan;44(1):168-79. doi: 10.1007/s10803-013-1862-3.

  PMID: 23748386 BACKGROUND

• Herlihy L, Knoch K, Vibert B, Fein D. Parents' first concerns about toddlers with autism spectrum disorder: effect of sibling status. Autism. 2015 Jan;19(1):20-8. doi: 10.1177/1362361313509731. Epub 2013 Nov 11.

  PMID: 24216070 BACKGROUND

• Guimond, A. B., Wilcox, M. J., & Lamorey, S. G. (2008). The Early Intervention Parenting SelfEfficacy Scale (EIPSES) scale construction and initial psychometric evidence. Journal of Early Intervention, 30(4), 295-320

  BACKGROUND

• Grzadzinski R, Lord C. Commentary: Insights into the Development of the Brief Observation of Social Communication Change (BOSCC). J Ment Health Clin Psychol. 2018;2(5):15-18. doi: 10.29245/2578-2959/2018/5.1166. Epub 2018 Oct 9. No abstract available.

  PMID: 30854524 BACKGROUND

• Grzadzinski R, Carr T, Colombi C, McGuire K, Dufek S, Pickles A, Lord C. Measuring Changes in Social Communication Behaviors: Preliminary Development of the Brief Observation of Social Communication Change (BOSCC). J Autism Dev Disord. 2016 Jul;46(7):2464-79. doi: 10.1007/s10803-016-2782-9.

  PMID: 27062034 BACKGROUND

• Dai YG, Thomas RP, Brennan L, Luu ML, Hughes-Lika J, Reilly M, Moreno P, Obe B, Ahmed KB, Berry LN, Goin-Kochel RP, Helt MS, Barton ML, Dumont-Mathieu T, Robins DL, Fein DA. An initial trial of OPT-In-Early: An online training program for caregivers of autistic children. Autism. 2023 Aug;27(6):1601-1615. doi: 10.1177/13623613221142408. Epub 2022 Dec 15.

  PMID: 36519775 BACKGROUND

• Dai YG, Thomas RP, Brennan L, Helt MS, Barton ML, Dumont-Mathieu T, Fein DA. Development and Acceptability of a New Program for Caregivers of Children with Autism Spectrum Disorder: Online Parent Training in Early Behavioral Intervention. J Autism Dev Disord. 2021 Nov;51(11):4166-4185. doi: 10.1007/s10803-020-04863-z. Epub 2021 Feb 2.

  PMID: 33527164 BACKGROUND

• Dai YG, Brennan L, Como A, Hughes-Lika J, Dumont-Mathieu T, Rathwell IC, Minxhozi O, Aliaj B, Fein DA. A Video Parent-Training Program for Families of Children with Autism Spectrum Disorder in Albania. Res Autism Spectr Disord. 2018 Dec;56:36-49. doi: 10.1016/j.rasd.2018.08.008. Epub 2018 Sep 10.

  PMID: 31275428 BACKGROUND

• Birdsong, D., Gertken, L. M., & Amengual, M. (2012). Bilingual language profile: An easy-to-use instrument to assess bilingualism. COERLL, University of Texas at Austin.

  BACKGROUND

• Abidin, R. (2012). Parenting Stress Index™, Fourth Edition Short Form. Lutz, Florida: Psychological Assessment Resources.

  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Katharine Zuckerman, MD MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine Zuckerman, MD MPH

CONTACT

503-494-6513; zuckerma@ohsu.edu

Luis A Rivas Vazquez, B.S.

CONTACT

503-494-5745; rivasvaz@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

US (2)