NCT05903053

Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of ADHD

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Infant Behavior
• Infant Development
• Self-Control
• Self-Regulation, Emotion

Interventions

Type	Name	Description
BEHAVIORAL	Early Self-Regulation Intervention	Participants enrolled in a separate protocol (UC Davis IRB ID#1077801) will be invited to participate upon meeting eligibility criteria. All participants will receive the intake and exit assessment battery, with the intake assessment battery being completed as part of IRBNet ID#1077801. A multiple baseline design across participants will be used with varying introduction of treatment elements for a subset of enrolled intervention participants. An intense intervention phase will follow the baseline phase in which 45-60 minute intervention sessions will occur two times per week for approximately 4-6 weeks for a total of 8 sessions. At the conclusion of the intense intervention phase, coaches will provide "booster" sessions once weekly for a month (4 sessions total).

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2023-06-15
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States