Clinical trial NCT05903053: Pilot Study: a Telehealth Intervention for Caregivers of Infants with Early Signs of ADHD
Official title: Pilot Study: a Telehealth Intervention for Caregivers of Infants with Early Signs of ADHD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant Behavior
Infant Development
Self-Control
Self-Regulation, Emotion
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: Child attention regulation
timeFrame: Change from baseline at intervention session #8 (end of week 4)
measure: Child inhibitory control
timeFrame: Change from baseline at intervention session #8 (end of week 4)
measure: Child emotion regulation
timeFrame: Change from baseline at intervention session #8 (end of week 4)
measure: Caregiver Fidelity of Implementation
timeFrame: Change from baseline at intervention session #8 (end of week 4)
measure: Parent Satisfaction Rating
timeFrame: Immediately following session #8 (end of week 4)
measure: Working Alliance Scale for Interventions with Children
timeFrame: Immediately following session #8 (end of week 4)
measure: Lab-TAB Toy Retraction Task
timeFrame: Change from baseline at intervention session #8 (end of week 4)
Secondary outcomes:
measure: Parent concerns interview
timeFrame: Change from baseline at intervention session #8 (end of week 4)
measure: Infant/Early Childhood Behavior Questionnaire (IBQ/ECBQ) - Effortful control
timeFrame: Change from baseline at intervention session #8 (end of week 4)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis MIND Institute
state: California
Study officials:
affiliation: University of California, Davis
name: Meghan Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: