Testing a Blended Social-Communication and Social-Emotional Intervention for Autistic Toddlers (BALANCED)
31 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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 de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
40
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Gospel Y Kim, Ph.D.
- Número de teléfono: 16263296989
- Correo electrónico: gospel_kim@baylor.edu
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
<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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
4
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
Comparador activo: 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.
|
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.
|
|
Comparador activo: 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.
|
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.
|
|
Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Child Behavior Checklist for Ages 1.5-5 Internalizing Problems T-Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Provider Coaching Fidelity Percentage
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
1 de septiembre de 2026
Finalización primaria (Estimado)
Finalización primaria
30 de septiembre de 2026
Finalización del estudio (Estimado)
Finalización del estudio
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
13 de septiembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
6 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2026
Última verificación
Última verificación
1 de septiembre de 2025
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2343845-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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