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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05903053
• Other study ID #: 2003351
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 18 Months

Eligibility

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).

Related Conditions & MeSH terms

• Infant Behavior
• Infant Development
• Self-Control

Intervention

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).

Locations

Country	Name	City	State
United States	UC Davis MIND Institute	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Parent concerns interview	The total number of parent concerns about child behavior and development will be examined. Fewer concerns reflects more positive outcomes.	Change from baseline at intervention session #8 (end of week 4)
Secondary	Infant/Early Childhood Behavior Questionnaire (IBQ/ECBQ) - Effortful control	The effortful control composite scores derived from these temperament rating scales will be examined. Higher scores reflect greater effortful control (i.e., more positive outcome).	Change from baseline at intervention session #8 (end of week 4)