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Can a remote parenting program tame toddler tantrums? new study investigates.

NCT ID NCT04594902

Prevention Sponsor: Florida International University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

The PANTHERS study tests a remote, home-based program called the Infant Behavior Program (IBP) to reduce behavior problems in infants aged 12-18 months from high-risk families. 288 families will receive either IBP or standard pediatric care, all conducted remotely. The goal is to see if this early intervention can prevent future behavior issues.

What this could mean

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

Active substance
Infant Behavior Program (IBP) - a remote, home-based behavioral intervention for parents and infants
What this could lead to
If successful, this could provide an effective, scalable way to prevent behavior problems in at-risk infants using remote sessions.
What could go wrong
This is a relatively small study (288 participants) and results may not apply to all families. The intervention is behavioral, so benefits depend on consistent participation.

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 288 people

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

Started

Mar 2021

Expected to finish

Sep 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 Criteria: * Infants ages 12 to 18 months and at least one primary caretaker, who is at least 18-years-old and in most cases will be the mother * Elevated score (\> 75th percentile) on the problem scale of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan et al., 2004) * An English-speaking or Spanish-speaking primary caregiver. Exclusion Criteria: * Infants with major sensory impairment (e.g., deafness blindness) or several problems that impair mobility (e.g., cerebral palsy) * Significant cognitive delay in the primary caregiver (i.e., estimated IQ score \< 70 on the vocabulary subtest of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) for those speaking English or an average standard score \< 4 on the vocabulary subtest of the Escala de Inteligencia Wechsler Para Adultos - Third Edition (EIWA-III) for those speaking Spanish) * Families involved with child protection services, which is expected to be low based on our pilot trials

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Conditions

The condition(s) this trial relates to.

psychiatric disorder

As listed by the trial registrant

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

Behavior problems Early childhood development

Contacts and locations

Locations

  • Nicklaus Children's Hospital

    Miami, Florida, 33155, United States

  • South Miami Children's Clinic

    Miami, Florida, 33143, United States

More trials for these conditions

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