This study is in progress, not accepting new patients

Pilot Study: a Telehealth Intervention for Caregivers of Infants with Early Signs of ADHD

a study on Infant Behavior Child Development Self-Control Self-Regulation, Emotion Attention-Deficit/Hyperactivity Disorder Caregivers

Summary

Eligibility
for people ages 12 months to 18 months (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Meghan Miller, Ph.D. (ucdavis)

Description

Summary

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.

Details

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.

Primary aims of this study include:

  1. Develop and test a telehealth-delivered, parent-mediated intervention targeting infant/toddler self-regulation in natural contexts, to aid both infant and caregiver learning.
  2. Identify, develop, and test measures/observations that can be gathered via telehealth contacts to assess ongoing change in infant and caregiver behavior over the course of the study.
  3. Test acceptability and satisfaction of the intervention and the telehealth delivery for families receiving the intervention.

Keywords

Infant Behavior, Infant Development, Self-Control, Self-Regulation, Emotion, Early Self-Regulation Intervention

Eligibility

For people ages 12 months to 18 months

Inclusion Critera:

Infants must be enrolled in UC Davis IRB protocol #1077801 and

  • Be between the ages of 12-18 months at the time of intake assessment,
  • Have a first-degree relative with ADHD (parent or sibling),
  • Exhibit early symptoms of ADHD based on examiner observation as indicated by at least 1 subscale on the Behavior Rating Inventory for Children (BRIC) rated 4 or higher,
  • Expression of at least 1 concern about the child's behavior/development by the caregiver.

Caregivers must:

  • Be identified as the infants' primary caregivers,
  • Be English-speaking,
  • Have access to wired or wireless network technology to access the internet in their homes.

Exclusion Criteria:

  • Birth before 33 weeks' gestation,
  • Known genetic disorders (e.g., fragile X syndrome, Tuberous Sclerosis),
  • History of traumatic brain injury,
  • Severe visual, hearing, or motor impairment or fragile health condition that would prevent the child from validly participating in the assessment procedures, and
  • A caregiver may be excluded from participation if the caregiver is already 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).

Location

  • UC Davis MIND Institute
    Sacramento California 95817 United States

Lead Scientist at University of California Health

  • Meghan Miller, Ph.D. (ucdavis)
    Associate Professor, MED: Psychiatry & Behav Sci, School of Medicine. Authored (or co-authored) 32 research publications. Research interests: Autism spectrum disorder · ADHD · Infancy · Early childhood · Early identification

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT05903053
Study Type
Interventional
Participants
Expecting 8 study participants
Last Updated