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Can a Dual-Pronged play therapy boost autistic Toddlers' social and emotional growth?

NCT ID NCT07748780

Disease control Sponsor: Baylor University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests a blended caregiver-led intervention for autistic toddlers under 3, combining social-communication strategies with social-emotional support. Caregivers are coached over 12 weekly sessions to embed these techniques into daily routines and play. The study aims to see if this approach improves toddlers' communication, emotional development, and reduces challenging behaviors, while also being practical for families.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A blended caregiver-mediated behavioral intervention combining Project ImPACT (social communication) with Pyramid Model practices (social-emotional development), delivered via 12 weekly coaching sessions.
What this could lead to
If successful, this could offer a practical way for early intervention programs to support both communication and emotional development in autistic toddlers, potentially reducing challenging behaviors.
What could go wrong
This is a small early-stage trial (40 participants), so results may not apply broadly. The intervention requires significant caregiver time and may not work for every child.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

\<Child Participant\> Inclusion Criteria: * Under 36 months of age at enrollment. * Has a clinical diagnosis of autism. * Is currently receiving services through Part C Early Intervention (EI). * Able to participate in natural caregiver-child routines and play activities. Exclusion Criteria: * Has a co-occurring medical condition (e.g., uncontrolled seizures, significant sensory or motor impairment) that would prevent participation in caregiver-child interaction sessions. * Not currently eligible for or receiving Part C services. * Previously participated in pilot testing of the blended intervention. \<Caregiver Participant\> Inclusion Criteria: * At least one primary caregiver is available and willing to participate in weekly coaching sessions for 12 weeks. * Caregiver agrees to participate in baseline, post-intervention, and follow-up assessments. * Caregiver consents to allow video recording of some sessions for fidelity monitoring and research purposes. * Caregiver has sufficient English proficiency to engage in intervention and assessment procedures (Spanish adaptation to follow in future phases). Exclusion Criteria * Unable to commit to the 12-week intervention schedule or 3-month follow-up. * Does not consent to video recording required for fidelity monitoring. * Insufficient English proficiency for participation in intervention sessions at this time.

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Conditions

The condition(s) this trial relates to.

autism Communication

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism Social emotional development delays

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.