Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT03592654|
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Developmental Delay||Behavioral: infant telehelp||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||single subject multiple baseline design|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder- Infant TeleHelp Study|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
Experimental: infant telehelp condition
caregiver coaching to improve infant behaviors that indicate they are at risk for autism spectrum disorder
Behavioral: infant telehelp
Adapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention
- Child Behaviors Targeted by Intervention [ Time Frame: 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.
- Autism Observation Scale for Infants [ Time Frame: 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.
- Ages and Stages Questionnaires, 3rd Edition [ Time Frame: 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.
- Individual Growth and Development Indices [ Time Frame: 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.
- Vineland Adaptive Behavior Scales, 2nd edition [ Time Frame: 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.
- Parent Satisfaction Rating [ Time Frame: 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.
- Working Alliance Scale for Interventions with Children [ Time Frame: 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.
- Caregiver Fidelity of Treatment Implementation [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592654
|Contact: Sarah Dufek, PhDemail@example.com|
|United States, California|
|Sacramento, California, United States, 95834|
|Contact: Sarah Dufek, PhD, BCBA-D 916-703-0239 firstname.lastname@example.org|
|Principal Investigator: Sarah Dufek, PhD, BCBA-D|
|Principal Investigator:||Sarah Dufek, PhD||UC Davis|