Community-based Adaptive Autism Intervention for Toddlers
Autism Spectrum Disorder
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 24 meses - 36 meses
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 201 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The proposed study (CAIT: Community-based Adaptive Autism Intervention for Toddlers) aims to determine the most optimal sequence of interventions for improving the social- communicative, language and cognitive outcomes of toddlers with autism spectrum disorder (ASD). The target population consists of 2-3 year-old children with ASD who receive community based, publicly funded early intervention in two authentic educational settings in East Harlem and the Bronx, NY known as New York Center for Infants \& Toddlers (NYCIT). An expected 300 toddlers with ASD will participate with their community-recruited paraprofessional teaching assistants (TAs) and group leaders (GLs). The study aims to construct the most effective one-year, two-phase, adaptive intervention, in which intervention is individualized based on a child's initial response to intervention. Phase 1, from program entry to either 6 or 12 weeks (randomized), involves 60 minutes daily of an evidence based social communication intervention, JASPER (Joint Attention, Symbolic Play, Engagement \& Regulation) delivered 1-on-1 to the child by the trained TA. At end of Phase 1, response to intervention is rated by the GLs for slow or fast improvements of joint engagement (a core deficit in the early development of children with ASD, and a significant indicator of good progress toward improving social communication and language). In Phase 2 (to week 24), toddlers responding slowly are re-randomized to continue with JASPER for 60 minutes per day or augment treatment with direct, structured teaching of social communication targets for 30 minutes and JASPER for another 30 minutes per day. Toddlers responding quickly are given 30 minutes of JASPER and 30 minutes of jasPEER (JASPER with a peer) to further improve socialization and social communication.
Leer la descripción completa
This study will use a Sequential Multiple Assignment Randomized Trial (SMART) design to assess when to examine initial response to treatment, as well as whether and how best to augment the current first line, standard of care intervention for children demonstrating a slower response.
First, at program entry, the investigators will assess all toddlers using both standardized and experimental assessments as they enroll in the NYCIT program. After entry assessments, the investigators will randomize each child with equal probability to early response assessment at either six weeks or 12 weeks (timing). This early response assessment will be used to determine whether children are considered fast or slow responders to treatment. Children who are considered early responders will continue to receive JASPER. Children responding slowly to the initial intervention will be randomized to continue JASPER or to add JASPER Plus+ to their JASPER sessions. Approximately 200-300 toddlers (24-36 months) with a diagnosis of ASD, as confirmed by clinical evaluation records required for placement at the NYCIT will participate. Children will be assessed prior to intervention, immediately after Stage 1(early response) at either six or twelve weeks, exit Stage 2 intervention, and follow up.
If teacher/paraprofessional withdraws from the study, all reasonable efforts will be made to place the child with another consenting teacher/paraprofessional. Based on the first two years of trials working with this center, no teacher withdrew mid study. However, a small number of teachers did change positions or took leave (e.g., maternity leave, move for job in another district). In these cases, the child was transferred to another consenting teacher.
SMART Design:
Initial Randomize to Stage 1 Treatment
Stage 1: JASPER (6 weeks)
Early Responders/Slow Responders determined
Stage 2: JASPER (Early Responders only)-A
Slow Responders randomized to Stage 2: JASPER Plus+ + JASPER -B or Stage 2: JASPER (Randomized for slow responders)-C A, B, and C options occur during the following 18 weeks
Exit assessments and Follow up assessments at 3 months post exit
Initial Randomized to Stage 1 Treatment
Stage 1: JASPER (12 weeks)
Early Responders/Slow Responders determined
Stage 2: JASPER (Early Responders only)- D Slow Responders randomized to Stage 2: JASPER Plus+ + JASPER - E or Stage 2: JASPER (Randomized for slow responders)- F D, E, and F options occur during the following 12 weeks
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Child Inclusion Criteria:
- diagnosis of ASD based on clinical report or ADOS-2 if needed
- chronological age less than 36 months
- caregiver consent to learn intervention strategies if randomized to either parent condition.
Exclusion Criteria:
- Child has co-morbid disorders such as cerebral palsy or down syndrome.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
JASPER (6 Weeks) + Responder + JASPER
Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 6 weeks. If child is an early responder, he/she will continue to do JASPER daily, 5 times a week, for the remaining 18 weeks of the study.
Behavioral: JASPER
JASPER (6 Weeks) + Slow Responder + JASPER
Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 6 weeks.
If child is a slow responder, he/she will continue to do JASPER daily, 5 times a week, for the remaining 18 weeks of the study.
Behavioral: JASPER
JASPER (6 Weeks) + Slow Responder + JASPER Plus
Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 6 weeks.
If child is a slow responder, he/she can get randomized to receive 30 minutes of JASPER Plus+ and 30 minutes of JASPER with a TA daily, 5 days a week for the remaining 18 weeks of the study.
Behavioral: JASPER · Behavioral: JASPER Plus+
JASPER (12 Weeks) + Responder + JASPER
Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 12 weeks. If child is an early responder, he/she will do JASPER for 60 minutes with TA, 5 times a week, for the remaining 12 weeks of the study.
Behavioral: JASPER
JASPER (12 Weeks) + Slow Responder + JASPER
Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 12 weeks.
If child is a slow responder, he/she can get randomized to continue his/her daily sessions of JASPER with the TA for an hour each day, 5 days a week for the following 12 weeks of the study.
Behavioral: JASPER
JASPER (12 Weeks) + Slow Responder + JASPER Plus
Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 12 weeks.
If child is a slow responder, he/she can get randomized to receive 30 minutes of JASPER Plus+ and 30 minutes of JASPER with a TA daily, 5 days a week for the remaining 12 weeks of the study.
Behavioral: JASPER · Behavioral: JASPER Plus+
JASPER BEHAVIORAL
JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the TA.
JASPER Plus+ BEHAVIORAL
JASPER Plus+ refers to direct instruction of social communication targets of pointing to share, showing gesures, and give to share gestures, and play targets at the child's target play level.
JASPER Plus+ will occur at a table top with repeated trials of instruction until the child can produce the desired behavior on their own.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Social Communicative Utterances (SCU)
Plazo: Baseline, Week 6, Week 12, and Week 24
SCUs are unprompted, generative (nonscripted) verbal utterances that are directed to a partner for the purpose of sharing information (comment) or making a request during a 15 minute assessment
Medidas secundarias
Play Levels/Types Using the Short Play and Communication Evaluation (SPACE)-Longitudinal
Plazo: baseline, exit
The total number of play types were coded from the 16 levels of play that ranged from indiscriminate to thematic play.
Joint Engagement-longitudinal
Plazo: baseline, exit
Proportion of time children and adult actively focus on shared objects/events
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
New York Center for Infants and Toddlers, Inc.New York, New York, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- University of California, Los Angeles
- Inicio del estudio
- 3 dic 2020 Real
- Finalización primaria
- 31 dic 2024 Real
- Finalización del estudio
- 31 dic 2024 Real
- Primera publicación
- 25 feb 2020 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Community-based Adaptive Autism Intervention for Toddlers
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026
