Autism Spectrum DisorderNCT07551752
A Digital Health Parent-Training Intervention for Children With Social Communication Delays
A study testing Online Parent Training in Early Behavioral Intervention (OPT-In-Early) in people with Autism Spectrum Disorder and Social Communication Delay, run by Florida International University at 1 site in United States.
Trial summary
Early intervention, during a time of optimal brain plasticity, is critical for autistic children to develop functional skills such as communication and daily living abilities. However, many families face barriers to accessing timely autism-specific services due to delays in autism diagnosis (which is often a… Read more about this study
- Who is it for?
- Ages 14 months and older
- Conditions the study is for
- Autism Spectrum Disorder, Social Communication Delay
- What is being tested?
- Online Parent Training in Early Behavioral Intervention (OPT-In-Early)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2026to May 2027
- 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 14 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children:
- aged 14 - 48 months
- screen positive on the M-CHAT-R/F or already have a diagnosis of autism
- Parents:
- Fluent in English
- Agree to complete both study visits and review OPT-In-Early if randomized to the intervention group
- At least 18 years old
- Have access to an internet-connected device
Who cannot join
- Children:
- Have a neurological condition that would preclude engagement in the intervention or testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida International University
Miami, Florida, 33199
Yael Dr. Yael Dai, PhD, 917-596-4459, ydai@fiu.edu
Julia M Grobman, B.S., 9547322143, jgrobman@fiu.edu
About this study
Early intervention, during a time of optimal brain plasticity, is critical for autistic children to develop functional skills such as communication and daily living abilities. However, many families face barriers to accessing timely autism-specific services due to delays in autism diagnosis (which is often a prerequisite to autism-specific intervention), long waitlists, high costs, and the necessity to travel far distances to service providers. Self-directed parent-mediated digital health interventions (i.e., programs that parents complete online without provider coaching or feedback) offer a scalable solution to reduce challenges accessing intervention by providing evidence-based strategies that parents can implement without relying on traditional service pathways. The proposed pilot randomized controlled trial (RCT) will test a revised self-directed parent-training program, that teaches parents naturalistic developmental behavioral intervention (NDBI) strategies, which have proven effective for young children with autism. The study will include young children who have already been diagnosed with autism and those who screen positive on an autism screener but have not yet been evaluated, enabling earlier intervention before a formal diagnosis. The study will also explore parents' willingness to engage in the intervention. The specific research aims are: (1) test the preliminary efficacy of the parent-training program vs. treatment as usual (TAU) for 50 children with autism traits and their parents; (2) examine parent engagement in the intervention; and (3) explore predictors of engagement.
- Being tested
- Online Parent Training in Early Behavioral Intervention (OPT-In-Early)
- Keywords
- Early intervention, Naturalistic Developmental Behavioral Intervention, Autism Spectrum Disorder, Social Communication Delay, parent training
- 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.
Online Parent Training in Early Behavioral Intervention (OPT-In-Early)Behavioural
OPT-In-Early is an online 14-module self-directed naturalistic developmental behavioral intervention (NDBI) that uses simple text, narration, and interspersed videos to teach parents how to increase their children's social engagement, communication, adaptive behaviors, and reduce challenging behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | This arm will complete treatment as usual during the 4 months of the study. Specifically, if the family is receiving any intervention, they will continue to receive it. Once the post-treatment study visit is completed, they will be granted access to the intervention being studied (OPT-In-Early) |
| Treatment (OPT-In-Early) group | Experimental | The intervention group will receive access to OPT-In-Early. OPT-In-Early is an online 14-module self-directed parent-training program that uses simple text, narration, and interspersed videos to teach parents how to increase their children's social engagement, communication, adaptive behaviors, and reduce challenging behaviors. Receives: Behavioral: Online Parent Training in Early Behavioral Intervention (OPT-In-Early) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Imitation Scale
We will administer a revised Motor Imitation Scale (MIS), a standardized, structured observational measure that assesses a child's ability to imitate familiar and novel motor actions. Children will see 5 actions modeled and then will be prompted to imitate the action using a matching toy. Children are given up to three opportunities to imitate each action. MIS scores range from 0 to 10, with higher scores indicating greater imitation.
Measured: Baseline and 4 months
Vineland Scales of Adaptive Behavior-3
The Vineland Scales of Adaptive Behavior-3 (Vineland-3) is a standardized parent interview measuring adaptive functioning. It will be administered to all participants at pre- and post-treatment to evaluate change occurring in adaptive behavior across groups. Previous research has documented that this measure has robust psychometric properties, is sensitive to change in response to early intervention, and captures dimensions that are highly valued by stakeholders. Higher scores in the Vineland indicate more advanced adaptive skills.
Measured: Baseline and 4 months
MacArthur-Bates Communicative Development Inventories (MCDI)
The MacArthur Bates Communication Development Inventory (MCDI) is a parent-report measure that assesses nonverbal communication (gestures) and verbal communication (words). The Words and Gestures form will be used. The MCDI is widely used, standardized, and validated. It is particularly well-suited for large-scale research due to ease of administration, strong psychometric properties, and sensitivity to individual differences in early language development. Higher scores indicate greater communication.
Measured: Baseline and 4 months
Secondary outcomes (3)
Goal Attainment Scaling
The Goal Attainment Scaling (GAS) is used to evaluate a participant's progress toward a specific, individualized goal. It follows standardized procedures that allow outcomes to be measured on a common metric, making it possible to compare intervention-related change across participants with different goals. Scores ranger from -2 to +2, with higher scores indicating better functioning.
Measured: Baseline and 4 months
OPT-In-Early Quiz
Parent gains in knowledge of OPT-In-Early strategies will be assessed with the OPT-In-Early Quiz, a 30-item multiple-choice quiz that assesses knowledge of NDBI content covered in the OPT-In-Early program. Scores will be based on the percentage of questions that parents answer correctly, with higher scores indicating greater knowledge of intervention content.
Measured: Baseline and 4 months
Treatment Evaluation Inventory Short-Form
The Treatment Evaluation Inventory Short-Form is a 9-item questionnaire, in which parents rate their acceptability of an intervention on a 5-point Likert scale. Scores are averaged and higher scores represent greater acceptability of the intervention. Parents randomized to the intervention condition will complete this measure at post-treatment.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start11 Apr 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be matched on child age and then randomized to intervention or treatment as usual using block randomization. Allocation will be concealed from the assessor completing post-treatment visits to prevent bias.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551752
- Sponsor's protocol ID
- IRB-25-0140
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 36519775Dai 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Health Parent-Training Intervention for Children With Social Communication Delays
- ClinicalTrials.gov ID
- NCT07551752
- Acronym / sponsor ID
- IRB-25-0140
- Keywords
- Early intervention, Naturalistic Developmental Behavioral Intervention, Autism Spectrum Disorder, Social Communication Delay, parent training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early intervention, during a time of optimal brain plasticity, is critical for autistic children to develop functional skills such as communication and daily living abilities. However, many families face barriers to accessing timely autism-specific services due to delays in autism diagnosis (which is often a prerequisite to autism-specific intervention), long waitlists, high costs, and the necessity to travel far distances to service providers. Self-directed parent-mediated digital health interventions (i.e., programs that parents complete online without provider coaching or feedback) offer a scalable solution to reduce challenges accessing intervention by providing evidence-based strategies that parents can implement without relying on traditional service pathways. The proposed pilot randomized controlled trial (RCT) will test a revised self-directed parent-training program, that teaches parents naturalistic developmental behavioral intervention (NDBI) strategies, which have proven effective for young children with autism. The study will include young children who have already been diagnosed with autism and those who screen positive on an autism screener but have not yet been evaluated, enabling earlier intervention before a formal diagnosis. The study will also explore parents' willingness to engage in the intervention. The specific research aims are: (1) test the preliminary efficacy of the parent-training program vs. treatment as usual (TAU) for 50 children with autism traits and their parents; (2) examine parent engagement in the intervention; and (3) explore predictors of engagement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be matched on child age and then randomized to intervention or treatment as usual using block randomization. Allocation will be concealed from the assessor completing post-treatment visits to prevent bias.
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | No intervention | –This arm will complete treatment as usual during the 4 months of the study. Specifically, if the family is receiving any intervention, they will continue to receive it. Once the post-treatment study visit is completed, they will be granted access to the intervention being studied (OPT-In-Early) |
| Treatment (OPT-In-Early) group | Experimental | Behavioral: Online Parent Training in Early Behavioral Intervention (OPT-In-Early)The intervention group will receive access to OPT-In-Early. OPT-In-Early is an online 14-module self-directed parent-training program that uses simple text, narration, and interspersed videos to teach parents how to increase their children's social engagement, communication, adaptive behaviors, and reduce challenging behaviors. |
Who may qualify
- Ages
- 14 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Children:
- aged 14 - 48 months
- screen positive on the M-CHAT-R/F or already have a diagnosis of autism
- Parents:
- Fluent in English
Key exclusion criteria (2 listed)
- Children:
- Have a neurological condition that would preclude engagement in the intervention or testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Parent Training in Early Behavioral Intervention (OPT-In-Early)OPT-In-Early is an online 14-module self-directed naturalistic developmental behavioral intervention (NDBI) that uses simple text, narration, and interspersed videos to teach parents how to increase their children's social engagement, communication, adaptive behaviors, and reduce challenging behaviors. | Behavioural | Treatment (OPT-In-Early) group |
Primary outcome
Motor Imitation Scale
Time frame: Baseline and 4 months
We will administer a revised Motor Imitation Scale (MIS), a standardized, structured observational measure that assesses a child's ability to imitate familiar and novel motor actions. Children will see 5 actions modeled and then will be prompted to imitate the action using a matching toy. Children are given up to three opportunities to imitate each action. MIS scores range from 0 to 10, with higher scores indicating greater imitation.
Vineland Scales of Adaptive Behavior-3
Time frame: Baseline and 4 months
The Vineland Scales of Adaptive Behavior-3 (Vineland-3) is a standardized parent interview measuring adaptive functioning. It will be administered to all participants at pre- and post-treatment to evaluate change occurring in adaptive behavior across groups. Previous research has documented that this measure has robust psychometric properties, is sensitive to change in response to early intervention, and captures dimensions that are highly valued by stakeholders. Higher scores in the Vineland indicate more advanced adaptive skills.
MacArthur-Bates Communicative Development Inventories (MCDI)
Time frame: Baseline and 4 months
The MacArthur Bates Communication Development Inventory (MCDI) is a parent-report measure that assesses nonverbal communication (gestures) and verbal communication (words). The Words and Gestures form will be used. The MCDI is widely used, standardized, and validated. It is particularly well-suited for large-scale research due to ease of administration, strong psychometric properties, and sensitivity to individual differences in early language development. Higher scores indicate greater communication.
3 secondary outcomes
Goal Attainment Scaling
Time frame: Baseline and 4 months
OPT-In-Early Quiz
Time frame: Baseline and 4 months
Treatment Evaluation Inventory Short-Form
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Results publication: PubMed 36519775Dai 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.
- Results publication: PubMed 33527164Dai 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Parent Training in Early Behavioral Intervention (OPT-In-Early) in people with Autism Spectrum Disorder and Social Communication Delay, run by Florida International University at 1 site 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yael Dai Dr. Yael Dai, PhD (305-348-1034, ydai@fiu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Imitation Scale (time frame: Baseline and 4 months). The study lists 3 primary outcomes in all. 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 NCT07551752, which also lists 2 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 27 Apr 2026.