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Telehealth Intervention for Infant Emotional Regulation

N/A
Waitlist Available
Led By Meghan Miller, Ph.D.
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following session #8 (end of week 4)
Awards & highlights

Summary

This trial will create an intervention to help early identify and help infants/toddlers with self-regulation difficulties using telehealth.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is a behavioral intervention delivered via telehealth, there are no direct medical side effects like those associated with medications or surgical procedures. However, participants may experience stress or fatigue due to involvement in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following session #8 (end of week 4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following session #8 (end of week 4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Caregiver Fidelity of Implementation
Child attention regulation
Child emotion regulation
+4 more
Secondary outcome measures
Infant/Early Childhood Behavior Questionnaire (IBQ/ECBQ) - Effortful control
Parent concerns interview

Trial Design

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).

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
919 Previous Clinical Trials
4,720,884 Total Patients Enrolled
1 Trials studying Infant Development
102 Patients Enrolled for Infant Development
Meghan Miller, Ph.D.Principal InvestigatorUniversity of California, Davis

Media Library

Early Self-Regulation Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05903053 — N/A
Infant Development Research Study Groups: Telehealth Intervention
Infant Development Clinical Trial 2023: Early Self-Regulation Intervention Highlights & Side Effects. Trial Name: NCT05903053 — N/A
Early Self-Regulation Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05903053 — N/A
~4 spots leftby Jul 2025