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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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).
UC Davis MIND Institute
Sacramento, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline at intervention session #8 (end of week 4)
Parent concerns interview
The total number of parent concerns about child behavior and development will be examined. Fewer concerns reflects more positive outcomes.
Time frame: Change from baseline at intervention session #8 (end of week 4)
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).
Time frame: Change from baseline at intervention session #8 (end of week 4)
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