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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following session #8 (end of week 4)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Caregiver Fidelity of Implementation

Child attention regulation

Child emotion regulation

+4 more

Secondary study objectives

Infant/Early Childhood Behavior Questionnaire (IBQ/ECBQ) - Effortful control

Parent concerns interview

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

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