AzTrials
AzTrials

Autism Spectrum DisorderNCT06908187

Opt-In Early Pilot Study

A study testing Opt-In Early Latinx intervention and Opt-In Early Rural Intervention in people with Autism Spectrum Disorder, run by Oregon Health and Science University at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 months and older
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Opt-In Early Latinx intervention and Opt-In Early Rural Intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesUnited States
Study dates
Dec 2025to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Katharine Zuckerman, MD MPH contact

503-494-6513

zuckerma@ohsu.edu

Luis A Rivas Vazquez, B.S. contact

503-494-5745

rivasvaz@ohsu.edu

United States2 sites

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

    Thyde Dumont-Mathieu, MD, 860-837-5758, TDumont@connecticutchildrens.org

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Katharine E Zuckerman, MD MPH, 503-494-6726, zuckerma@ohsu.edu

    Luis Rivas Vazquez, 503-494-5745

Other trials in United States

About this study

Official title: Parent Training for Autistic Toddlers: Development and Preliminary Testing

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.

Being tested
Opt-In Early Latinx intervention, Opt-In Early Rural Intervention
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opt-In Early Latinx interventionOther

    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.

  • Opt-In Early Rural InterventionOther

    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.

Study groups in NCT06908187
Study groupRoleWhat they receive
Intervention Now - LatinxExperimentalFamilies 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.
Receives: Other: Opt-In Early Latinx intervention
Intervention Later (Control)No interventionFamilies 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 - RuralExperimentalFamilies 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.
Receives: Other: Opt-In Early Rural Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Autism Impact Measure (AIM)

    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

    Measured: Once at baseline evaluation and a second at the end of the six months of intervention.

  2. Brief Observation of Social Communication Change (BOSCC)

    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.

    Measured: It is administered at the baseline evaluation and after the six months of intervention or psycho-education.

  3. Early Intervention Parenting Self-Efficacy Scale (EIPSES)

    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.

    Measured: 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.

  4. Parenting Stress Index (PSI-4)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06908187
Sponsor's protocol ID
STUDY00025956
Other IDs
R34MH132712, no number
Status last verified
Apr 2025
First submitted
14 Mar 2025
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We will be submitting data to NIMH NDA archive as required by the funder

Publications

  • 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

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

  • 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.

    PubMed 29344761

  • 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.

    PubMed 33001561

  • 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.

  • 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.

    PubMed 23748386

  • 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.

    PubMed 24216070

  • 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

  • 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.

    PubMed 30854524

  • 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.

    PubMed 27062034

  • 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.

    PubMed 36519775

  • 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.

    PubMed 33527164

  • 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.

    PubMed 31275428

  • 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Opt-In Early Latinx intervention and Opt-In Early Rural Intervention in people with Autism Spectrum Disorder, run by Oregon Health and Science University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katharine Zuckerman, MD MPH (503-494-6513, zuckerma@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Interaction Rating Scale (SIRS) (time frame: It is administered pre- and post-six months of intervention to both groups.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06908187, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in