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Can a video call help parents of fussy babies at risk for ADHD?

NCT ID NCT05903053

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This pilot study tests a telehealth-delivered training program for caregivers of infants (12-18 months old) who show early signs of ADHD, such as trouble with self-control or emotion regulation. The program teaches caregivers strategies to support their child's development through video coaching sessions. Only 8 families are enrolled, and the study focuses on whether the program is feasible and acceptable, not on curing ADHD.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Early Self-Regulation Intervention (behavioral training for caregivers delivered via telehealth)
What this could lead to
If successful, this could point toward a practical, home-based way to help caregivers support infants with early self-regulation difficulties, potentially reducing later ADHD symptoms.
What could go wrong
This is a very small pilot study (8 participants) with no control group, so results may not apply broadly. The intervention is still in early testing and may not show clear benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 18 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

attention deficit-hyperactivity disorder Emotional Regulation Infant Behavior Self-Control

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UC Davis MIND Institute

    Sacramento, California, 95817, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.