Telehealth Intervention for Infant Emotional Regulation

Recruiting in Palo Alto (17 mi)

Overseen ByMeghan Miller, Ph.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Davis

No Placebo Group

Trial Summary

What is the purpose of this trial?This project will build on the investigators' work focused on early identification of ADHD, expanding to the development of a feasibility/pilot intervention involving early intervention for such infants. The investigators will evaluate the effectiveness of a telehealth-delivered, caregiver-implemented supportive intervention for infants/toddlers show early self-regulation difficulties.

Eligibility Criteria

This trial is for caregivers of infants aged 12-18 months who show early signs of ADHD and have a relative with ADHD. Infants must exhibit certain behaviors indicating potential ADHD, and caregivers need to express concerns about the child's behavior. Participants must speak English and have internet access at home.

Inclusion Criteria

My infant has a parent or sibling with ADHD.

Caregivers must have access to wired or wireless network technology to access the internet in their homes

Infants must have at least 1 concern about the child's behavior/development expressed by the caregiver

+5 more

Exclusion Criteria

My infant has a genetic disorder like fragile X or Tuberous Sclerosis.

My infant has had a traumatic brain injury.

My baby was born before reaching 33 weeks of pregnancy.

+2 more

Participant Groups

The study tests a telehealth-delivered intervention aimed at supporting caregivers in managing infants with early self-regulation difficulties that may indicate signs of ADHD. The effectiveness of this caregiver-implemented program will be evaluated remotely.

1Treatment groups

Experimental Treatment

Group I: Telehealth InterventionExperimental Treatment1 Intervention

A multiple baseline design across subjects will be used with varying introduction of treatment elements. Baseline periods will be 3, 5, and 7 sessions with the baseline period of 3 and 5 sessions repeated twice for subsequent participants. An intense intervention phase will follow the baseline phase in which 45-60 minute treatment sessions will occur twice per week over the course of 4-6 weeks for a total of 8 sessions. Each week during the intense intervention phase, caregiver coaches will introduce a new treatment technique to the caregiver and allow for caregiver practice with immediate feedback. At the conclusion of the intense intervention phase, coaches will provide "booster" sessions with the caregivers once weekly for 1 month (4 sessions total).