Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder
2 de septiembre de 2020 actualizado por: University of California, Davis
Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder- Infant TeleHelp Study
Caregiver coaching will be provided using telehealth technology, in order to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Ideally, all caregivers with an infant identified with concern for ASD would have immediate access to good quality caregiver coaching provided in the most natural environment possible.
However, this is currently not the case for the majority of families.
There are no empirically validated treatment programs for infants showing ASD risk.
The proposed research project will use Applied Behavior Analysis-based single-subject experimental designs to further develop a promising caregiver-mediated intervention designed for infants showing early signs of ASD.
Caregiver coaching will be provided using telehealth technology, in order to maximize recruitment opportunities and to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
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.
Ubicaciones de estudio
-
-
California
-
Sacramento, California, Estados Unidos, 95834
- MIND institute
-
-
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
Edades elegibles para estudiar
5 meses a 1 año (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Infants must exhibit early symptoms of ASD as indicated by a combination of Autism Observation Scale for Infants (AOSI) scores of 7 or higher
- and Infant Toddler Checklist (ITC) scores in the autism concern range
- Expression of clinical concern about ASD risk by the assessor and caregiver
- Caregivers must be identified as the infants' primary caregivers
- Caregivers be English speaking
- Caregivers must have access to wired or wireless network technology to access the internet in their homes.
Exclusion Criteria:
- Infants may not have had significant abnormalities in the pre-, peri-, and postnatal period or gestational age younger than 34 weeks
- Infants may not have serious medical conditions involving repeated or lengthy hospitalizations, head injuries, seizures, cerebral palsy or impaired hand use
- Infants may not have multiple daily administrations of medical treatment (e.g., nebulizers daily)
- Infants may not have known genetic syndrome associated with ASD (e.g., fragile X syndrome) Infants may not have moderate to severe visual, auditory, or motor impairments
- A caregiver may be excluded from participation if the caregiver is engaging in the majority of all possible caregiver treatment target behaviors at therapeutic levels during intake (Fidelity of Implementation scores of 80% or higher on each caregiver target behavior).
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: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: infant telehelp condition
caregiver coaching to improve infant behaviors that indicate they are at risk for autism spectrum disorder
|
Adapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Child Behaviors Targeted by Intervention
Periodo de tiempo: 7 months
|
Treatment-targeted child behaviors (e.g., visual fixations on objects, abnormal repetitive behaviors, lack of age-appropriate phonemic development, lack of coordination of gaze, affect, and voice in reciprocal, turn-taking interactions) will be coded from 10-minute caregiver-infant dyad intervention video probes taken throughout all phases of the study.
|
7 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Autism Observation Scale for Infants
Periodo de tiempo: 7 months
|
(AOSI; Bryson et al., 2006) The AOSI will be administered by caregivers at intake and exit.
During the AOSI, infants are engaged in semi-structured play and systematic presses are designed to assess various target behaviors, including visual tracking and attention disengagement, coordination of eye gaze and action, imitation, affective responses, early social-communicative behaviors, behavioral reactivity, and sensory-motor development.
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7 months
|
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Ages and Stages Questionnaires, 3rd Edition
Periodo de tiempo: 7 months
|
(ASQ-3; Squires & Bricker, 2015) The ASQ-3 are a series of questionnaires completed by a child's caregiver designed to assess the developmental performance of infants and children ages 1-66 months across five developmental areas: communication, gross motor, fine motor, problem solving, and personal-social.
The ASQ-3 takes approximately 15 minutes to be completed.
|
7 months
|
|
Individual Growth and Development Indices
Periodo de tiempo: 7 months
|
(IGDIs; Carta et al., 2010) IGDIs were developed to gather very frequent assessment of child developmental progress.
We will use the Early Communication Index, ECI, and the Early Problem Solving Index, EPSI, domains appropriate for ages 5 to 50 mos.
Two 6-minute semi-structured and video recorded play procedures will be carried out at intake and exit.
|
7 months
|
|
Vineland Adaptive Behavior Scales, 2nd edition
Periodo de tiempo: 7 months
|
(VABS-II; Sparrow et al., 2005) The VABS-II consists of four domains of adaptive behavior: communication, self-care, social, and motor skills.
The VABS-II is a semi-standardized caregiver questionnaire or interview designed to assess children's behavior in real life, everyday settings.
|
7 months
|
|
Parent Satisfaction Rating
Periodo de tiempo: 7 months
|
(Charlop-Christy & Carpenter, 2000) This is a measure of social validity, or acceptability, of the experimental treatment, to caregivers.
This scale will be administered to the caregivers at intake and exit.
This tool allows caregivers to rate the ease of implementation in the home and their opinions concerning treatment utility.
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7 months
|
|
Working Alliance Scale for Interventions with Children
Periodo de tiempo: 7 months
|
(Davis et al., 2006).
These measures will be administered to the caregivers at intake and exit and will be used to describe the response of the families to the experimental intervention, and thus constitutes another measure of social validity.
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7 months
|
|
Caregiver Fidelity of Treatment Implementation
Periodo de tiempo: 7 months
|
Caregiver fidelity of implementation (FI) of the Infant Start intervention will be coded from 10-minute caregiver-child dyad intervention video probes to determine caregivers' FI of intervention techniques over the course of the study.
The fidelity tool involves having experts in Infant Start rate caregiver use of each of the intervention strategies on a 1-5 Likert rating scale, with a code of "1" meaning the caregiver did not implement the technique throughout the session and a code of "5" meaning the caregiver implemented the technique correctly throughout the session.
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7 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sarah Dufek, PhD, UC Davis
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 (Actual)
1 de julio de 2018
Finalización primaria (Actual)
18 de septiembre de 2019
Finalización del estudio (Actual)
1 de octubre de 2019
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2018
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2018
Publicado por primera vez (Actual)
19 de julio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1249018
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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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