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Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder

2. september 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95834
        • MIND institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 måneder til 1 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: infant telehelp condition
caregiver coaching to improve infant behaviors that indicate they are at risk for autism spectrum disorder
Adfærdsmæssigt: infant telehelp
Adapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child Behaviors Targeted by Intervention
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Autism Observation Scale for Infants
Tidsramme: 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.
7 months
Ages and Stages Questionnaires, 3rd Edition
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
7 months
Working Alliance Scale for Interventions with Children
Tidsramme: 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.
7 months
Caregiver Fidelity of Treatment Implementation
Tidsramme: 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.
7 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Davis

Efterforskere

  • Ledende efterforsker: Sarah Dufek, PhD, UC Davis

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2018

Primær færdiggørelse (Faktiske)

18. september 2019

Studieafslutning (Faktiske)

1. oktober 2019

Datoer for studieregistrering

Først indsendt

25. juni 2018

Først indsendt, der opfyldte QC-kriterier

17. juli 2018

Først opslået (Faktiske)

19. juli 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1249018

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Autismespektrumforstyrrelse

Kliniske forsøg med infant telehelp

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner