An interventional study of Early Self-Regulation Intervention in Infant Behavior, Infant Development and Self-Control, sponsored by University of California, Davis. Active, not recruiting at 1 site in United States. Open to participants aged 12 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
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:
545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.
This study's planned enrollment of 8 is below the median of 79 across 498 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
Compared within Emotional Regulation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infant Behavior. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Infants must be enrolled in UC Davis IRB protocol #1077801 and
Caregivers must:
Exclusion Criteria:
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
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).
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)
Plan to share: No
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This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of California, Davis →