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

University of California (UC) Davis

Status: Active, not recruiting

Conditions: Self-Regulation, Emotion; Infant Behavior; Infant Development; Self-Control

Treatments: Behavioral: Early Self-Regulation Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05903053

2003351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Telehealth Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Early Self-Regulation Intervention