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

31 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

<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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Child Behavior Checklist for Ages 1.5-5 Internalizing Problems T-Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Provider Coaching Fidelity Percentage
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Baylor University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

13 settembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

31 luglio 2026

Primo Inserito (Effettivo)

6 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 luglio 2026

Ultimo verificato

1 settembre 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2343845-1

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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