Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers (BALANCED)

July 31, 2026 updated by: Gospel Kim, Baylor University

Autistic toddlers often need support to develop both social-communication and social-emotional skills. Social communication (such as making requests or sharing attention) is usually addressed in early intervention, but social-emotional needs (such as expressing feelings or learning to cope with frustration) are often overlooked. Both are important for children's development and for preventing challenging behaviors.

This study is testing a blended intervention designed to support both areas at the same time. The program combines Project ImPACT, a caregiver-mediated social communication intervention, with universal practices from the Pyramid Model, a national framework for promoting young children's social-emotional development.

Caregivers of autistic toddlers will be coached by early intervention providers to use strategies during everyday routines and play. The study will enroll 40 caregiver-toddler pairs, randomly assigning them to one of four study conditions. Families assigned to the waitlist control group will receive the intervention after a delay.

The goal is to understand whether this blended approach improves toddlers' communication and emotional development, and whether caregivers find it helpful and practical in daily life. Because many states and early intervention systems already use the Pyramid Model, this study could provide a way to make those programs more inclusive of autistic children and their families.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Supporting social communication in autistic children is essential, but their social-emotional needs are often overlooked even though both are critical for early development and for preventing challenging behavior. National efforts such as the Pyramid Model aim to promote social-emotional skills for all young children, yet autistic children are often excluded in practice.

This community-partnered study, shaped by autistic voices and family input, addresses that gap by testing a blended intervention that integrates:

Project ImPACT, an evidence-based intervention to support social communication, and Pyramid Model universal practices, strategies that promote social-emotional development.

The study will use a randomized controlled trial with a waitlist control group to evaluate outcomes for 40 caregiver-toddler dyads. Families will be assigned to one of four conditions. Early intervention providers will coach caregivers to embed strategies into daily routines, helping children learn in natural settings.

With nearly 40 states having adopted the Pyramid Model, this study offers a timely opportunity to collaborate with Part C early intervention programs to strengthen their focus on both social communication and social-emotional skills. By supporting integration across these developmental domains, the project aims to enhance the quality and inclusivity of early intervention services for autistic toddlers and their families.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

<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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Blended Intervention (Project ImPACT + Pyramid Model)
Caregiver-toddler dyads will receive a blended intervention that integrates Project ImPACT strategies to support social communication with Pyramid Model universal practices to promote social-emotional development. Early intervention providers will coach caregivers during weekly sessions across 12 weeks, focusing on embedding strategies into daily routines and play.
Behavioral: Blended Intervention (Project ImPACT + Pyramid Model)
A caregiver-mediated intervention that integrates Project ImPACT strategies for social communication with Pyramid Model universal practices to promote social-emotional development. Early intervention providers will coach caregivers across 12 weekly sessions to embed blended strategies into daily routines and play.
Active Comparator: Project ImPACT Only
Caregiver-toddler dyads will receive Project ImPACT, a parent-mediated intervention that targets social communication skills such as language, joint attention, and reciprocity. Early intervention providers will coach caregivers during weekly sessions across 12 weeks, focusing on embedding Project ImPACT strategies into daily routines.
Behavioral: Project ImPACT
An evidence-based parent-mediated intervention designed to improve social communication, language, and reciprocity in young autistic children. Early intervention providers will coach caregivers in Project ImPACT strategies across 12 weekly sessions, focusing on embedding practices into natural routines.
Active Comparator: Pyramid Model Only
Caregiver-toddler dyads will receive Pyramid Model universal practices (Tier 1), which promote nurturing relationships, supportive environments, and emotional literacy. Early intervention providers will coach caregivers during weekly sessions across 12 weeks, helping families embed these social-emotional promotion strategies into daily routines.
Behavioral: Pyramid Model Universal Practices
A framework for promoting social-emotional development and preventing challenging behaviors through universal practices (Tier 1). Providers will coach caregivers across 12 weekly sessions to embed practices such as nurturing relationships, supportive environments, and emotional literacy into daily routines.
No Intervention: Waitlist Control (Usual Care)
Caregiver-toddler dyads will continue receiving their usual early intervention services during the 12-week study period. Following post-intervention data collection, families assigned to this arm will be offered the blended intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Child Behavior Checklist for Ages 1.5-5 Internalizing Problems T-Score
Time Frame: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
The Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5) is a caregiver-report measure of child emotional and behavioral problems. The Internalizing Problems raw score is calculated by summing relevant items from the Emotionally Reactive, Anxious/Depressed, Somatic Complaints, and Withdrawn syndrome scales. Scores range from 0 to 72, with higher scores indicating greater internalizing behavior problems and therefore a worse outcome.
Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Change in Brief Observation of Social Communication Change-Minimally Verbal Total Score
Time Frame: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Social communication and related autism characteristics will be measured using the Brief Observation of Social Communication Change-Minimally Verbal version (BOSCC-MV), coded from recorded caregiver-child interactions. The total score ranges from 0 to 75, with higher scores indicating greater social-communication and autism-related impairment and therefore a worse outcome.
Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Change in Frequency of Child Challenging Behavior During Caregiver-Child Routines
Time Frame: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Trained observers will code the frequency of operationally defined child challenging behaviors during recorded caregiver-child routines. The reported value will be the number of challenging behavior episodes observed during each session. The minimum possible value is 0 episodes; there is no fixed maximum. Higher values indicate more frequent challenging behavior and therefore a worse outcome.
Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Change in Child Behavior Checklist for Ages 1.5-5 Externalizing Problems Raw Score
Time Frame: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
The Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5) is a caregiver-report measure of child emotional and behavioral problems. The Externalizing Problems raw score is calculated by summing relevant items from the Attention Problems and Aggressive Behavior syndrome scales. Scores range from 0 to 48, with higher scores indicating greater externalizing behavior problems and therefore a worse outcome.
Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Change in Devereux Early Childhood Assessment for Infants and Toddlers Total Protective Factors T-Score
Time Frame: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Caregiver-reported social-emotional competence will be measured using the Devereux Early Childhood Assessment for Infants and Toddlers (DECA-I/T). The age-appropriate Infant Form (DECA-I; ages 1 month to 18 months) or Toddler Form (DECA-T; ages 18 months to 36 months) will be administered. The Total Protective Factors T-score summarizes initiative and attachment/relationships for infants and initiative, attachment/relationships, and self-regulation for toddlers. T-scores range from 28 to 72, with higher scores indicating greater social-emotional competence and therefore a better outcome.
Baseline, 12 weeks (post-intervention), and 3-month follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Provider Coaching Fidelity Percentage
Time Frame: During the 12-week intervention period, with sessions sampled across the intervention.
Provider adherence to the coaching procedures will be assessed from recorded coaching sessions using a study-developed provider coaching fidelity rubric. The fidelity score is calculated as the percentage of applicable coaching components implemented correctly. Scores range from 0% to 100%, with higher percentages indicating greater provider coaching fidelity and therefore a better outcome. Approximately 33% of recorded coaching sessions will be randomly selected for fidelity coding.
During the 12-week intervention period, with sessions sampled across the intervention.
Caregiver-Rated Intervention Acceptability Mean Score
Time Frame: 12 weeks (post-intervention).
Caregiver perceptions of intervention acceptability and usefulness will be measured using a study-developed social validity survey. The acceptability score is calculated as the mean of the acceptability items, each rated from 1 to 5. Mean scores range from 1 to 5, with higher scores indicating greater intervention acceptability and therefore a better outcome.
12 weeks (post-intervention).
Caregiver-Rated Intervention Feasibility Mean Score
Time Frame: 12 weeks (post-intervention).
Caregiver perceptions of intervention feasibility will be measured using a study-developed social validity survey. The feasibility score is calculated as the mean of the feasibility items, each rated from 1 to 5. Mean scores range from 1 to 5, with higher scores indicating greater perceived feasibility and therefore a better outcome.
12 weeks (post-intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2343845-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The research team has not yet determined whether de-identified individual participant data (IPD) will be shared. Decisions will depend on IRB guidance, funding agency requirements, and feasibility of preparing anonymized datasets while maintaining participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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