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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592654
• Other study ID #: 1249018
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: September 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 1, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 12 Months

Eligibility

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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Delay

Intervention

Behavioral:
• infant telehelp
Adapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention

Locations

Country	Name	City	State
United States	MIND institute	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Behaviors Targeted by Intervention	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
Secondary	Autism Observation Scale for Infants	(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
Secondary	Ages and Stages Questionnaires, 3rd Edition	(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
Secondary	Individual Growth and Development Indices	(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
Secondary	Vineland Adaptive Behavior Scales, 2nd edition	(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
Secondary	Parent Satisfaction Rating	(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
Secondary	Working Alliance Scale for Interventions with Children	(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
Secondary	Caregiver Fidelity of Treatment Implementation	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