AutismBALANCEDNCT07748780
Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers
A study testing Blended Intervention (Project ImPACT + Pyramid Model), Project ImPACT and Pyramid Model Universal Practices in people with Autism and Social Emotional Development Delays, run by Baylor University.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism, Social Emotional Development Delays
- What is being tested?
- Blended Intervention (Project ImPACT + Pyramid Model), Project ImPACT and Pyramid Model Universal Practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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).
Who cannot join
- 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>
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Autism, Social Emotional Development Delays
- Being tested
- Blended Intervention (Project ImPACT + Pyramid Model), Project ImPACT, Pyramid Model Universal Practices
- Keywords
- Autism, Social Communication, Social Emotional, Early Intervention, Project ImPACT, Pyramid Model, Community-Partnered Research
- Medical subject headings
- Autistic Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended Intervention (Project ImPACT + Pyramid Model)Behavioural
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.
Project ImPACTBehavioural
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.
Pyramid Model Universal PracticesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Blended Intervention (Project ImPACT + Pyramid Model) | Experimental | 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. Receives: Behavioral: Blended Intervention (Project ImPACT + Pyramid Model) |
| Project ImPACT Only | Active comparator | 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. Receives: Behavioral: Project ImPACT |
| Pyramid Model Only | Active comparator | 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. Receives: Behavioral: Pyramid Model Universal Practices |
| Waitlist Control (Usual Care) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Behavior Checklist for Ages 1.5-5 Internalizing Problems T-Score
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.
Measured: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Change in Brief Observation of Social Communication Change-Minimally Verbal Total Score
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.
Measured: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Change in Frequency of Child Challenging Behavior During Caregiver-Child Routines
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.
Measured: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Change in Child Behavior Checklist for Ages 1.5-5 Externalizing Problems Raw Score
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.
Measured: 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
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.
Measured: Baseline, 12 weeks (post-intervention), and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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 randomly assigned to one of four arms: (1) blended intervention (Project ImPACT + Pyramid Model practices), (2) Project ImPACT only, (3) Pyramid Model only, or (4) waitlist control. Randomization occurs at the provider level to reduce contamination, with each provider assigned to two caregiver-toddler dyads.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gospel Kim, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748780
- Sponsor's protocol ID
- 2343845-1
- Acronym
- BALANCED
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers
- ClinicalTrials.gov ID
- NCT07748780
- Acronym / sponsor ID
- BALANCED / 2343845-1
- Conditions
- Autism, Social Emotional Development Delays
- Keywords
- Autism, Social Communication, Social Emotional, Early Intervention, Project ImPACT, Pyramid Model, Community-Partnered Research
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Aug 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of four arms: (1) blended intervention (Project ImPACT + Pyramid Model practices), (2) Project ImPACT only, (3) Pyramid Model only, or (4) waitlist control. Randomization occurs at the provider level to reduce contamination, with each provider assigned to two caregiver-toddler dyads.
| Arm | Type | Receives |
|---|---|---|
| Blended Intervention (Project ImPACT + Pyramid Model) | Experimental | Behavioral: 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. |
| Project ImPACT Only | Active comparator | Behavioral: Project ImPACTCaregiver-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. |
| Pyramid Model Only | Active comparator | Behavioral: Pyramid Model Universal PracticesCaregiver-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. |
| Waitlist Control (Usual Care) | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- At least one primary caregiver is available and willing to participate in weekly coaching sessions for 12 weeks.
Key exclusion criteria (7 listed)
- 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>
- Unable to commit to the 12-week intervention schedule or 3-month follow-up.
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 |
|---|---|---|
| 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. | Behavioural | Blended Intervention (Project ImPACT + Pyramid Model) |
| Project ImPACTAn 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. | Behavioural | Project ImPACT Only |
| Pyramid Model Universal PracticesA 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. | Behavioural | Pyramid Model Only |
Primary outcome
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.
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.
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.
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.
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.
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 6 Aug 2026.
- Individual participant dataSharing planned: Undecided. 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Blended Intervention (Project ImPACT + Pyramid Model), Project ImPACT and Pyramid Model Universal Practices in people with Autism and Social Emotional Development Delays, run by Baylor University.
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 7 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Gospel Y Kim, Ph.D. (16263296989, gospel_kim@baylor.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.