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

NCT05903053 | Active Not Recruiting

• 1 other identifier: 2003351
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Child attention regulation

  Child duration of orienting during the intervention sessions will be coded from video using a standardized behavioral coding paradigms developed within the investigators' lab.

  Change from baseline at intervention session #8 (end of week 4)

• Child inhibitory control

  Child frequency of grabbing behavior during the intervention sessions will be coded from video using a standardized behavioral coding paradigms developed within the investigators' lab.

  Change from baseline at intervention session #8 (end of week 4)

• Child emotion regulation

  Child frequency of negative affect during the intervention sessions will be coded from video using a standardized behavioral coding paradigms from the Lab-TAB. Higher levels equate to more negative affect.

  Change from baseline at intervention session #8 (end of week 4)

• Caregiver Fidelity of Implementation

  Caregiver fidelity of implementation (FI) of the intervention will be coded from 3-minute caregiver-child dyad intervention video probes to determine caregivers' FI of intervention techniques over the course of the study. This involves having experts in the intervention rate caregiver use of each of the intervention strategies on a 1-5 Likert rating scale, with a code of "1" meaning the caregiver did not implement the technique throughout the session and a code of "5" meaning the caregiver implemented the technique correctly throughout the session. An FI score of 80% (determined by total caregiver points out of the maximum possible points multiplied by 100) or higher for the entire intervention session indicates success in caregivers' FI of intervention techniques. Higher values represent greater fidelity.

  Change from baseline at intervention session #8 (end of week 4)

• Parent Satisfaction Rating

  This is a measure of social validity, or acceptability, of the experimental treatment, to caregivers. This tool allows caregivers to rate the ease of implementation in the home and their opinions concerning treatment utility. Higher scores indicate greater satisfaction with the intervention.

  Immediately following session #8 (end of week 4)

• Working Alliance Scale for Interventions with Children

  This will be used to describe the response of the families to the intervention in terms of perceived alliance with the coach. Higher scores equate to more positive working alliance.

  Immediately following session #8 (end of week 4)

• Lab-TAB Toy Retraction Task

  This task involves a standardized press for negative affect. The duration of negative affect during the task will be coded from video. Higher levels equate to more negative affect.

  Change from baseline at intervention session #8 (end of week 4)

Secondary Outcomes (2)

• Parent concerns interview

  Change from baseline at intervention session #8 (end of week 4)

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

  Change from baseline at intervention session #8 (end of week 4)

Study Arms (1)

Telehealth Intervention

EXPERIMENTAL

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).

Behavioral: Early Self-Regulation Intervention

Interventions

Early Self-Regulation Intervention BEHAVIORAL

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).

Telehealth Intervention

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis MIND Institute

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Infant Behavior; Self-Control; Emotional Regulation

Condition Hierarchy (Ancestors)

Child Behavior; Behavior; Social Behavior

Study Officials

• Meghan Miller, Ph.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: June 15, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)