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Smartphone app may boost parenting skills for child outbursts

NCT ID NCT07764536

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Sep 18, 2026 · Updated 24 times

Summary

This trial tests whether a smartphone app can enhance parent management training (PMT) for children aged 8 to 13 with disruptive behavior disorders, such as conduct disorder or ADHD. Parents receive 12 weekly PMT sessions, and half also use a digital tool with videos, a resource library, and alerts to help practice skills. The study compares dropout rates and measures of irritability and outbursts to see if the app makes training more effective.

What this could mean

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

Active substance
A smartphone app used alongside parent management training to help parents practice skills for managing child temper outbursts.
What this could lead to
If it works, this could point toward a practical, low-cost way to boost the effectiveness of parent training for children with disruptive behavior disorders.
What could go wrong
This is a mid-sized trial, and the app may not improve outcomes or reduce dropout. Success depends on parents actually using the app consistently.

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.

Participants

About 200 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2037

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Who is studied

This study is for children 8-13 years old with irritability as a primary clinical concern and no more than minimal response to current treatment. At least one parent/guardian must be willing to enroll and have the cognitive ability to consent, and the child must be able to understand and willing to sign a written assent document. The enrolled, consented parent must be willing to attend 12 parent management training sessions and use the study s digital tool. Both parent and child must be fluent in English. Exclusion criteria for children are active major depression or history of psychosis, bipolar I disorder, level 2 or 3 autism spectrum disorder, active severe substance use, active suicidal intent or plan, IQ below 70, or medical or neurological conditions that may interfere with study participation. Exclusion criteria for parents are IQ below 70, medical/mental health conditions that interfere with participation, or current substance or alcohol problems requiring separate treatment.

Ages

8 to 13 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Inclusion Criteria for Youth: To be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria: * Enrollment into protocol 01-M-0254 for screening purposes * Age 8-13 years (8 years 0 months through 13 years 11 months) * Parent/guardian and/or child reports irritability as a primary clinical concern. Specifically, compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property. This criterion is assessed based on the clinical interview conducted with parent/guardian and child after consenting into protocol 01-M-0254 for screening. * On the basis of record review and interviews with child and parent or guardian, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e., CGI-S of 3 or more). This criterion is assessed based on the clinical interview conducted with parent/guardian and child after consenting into protocol 01-M-0254 for screening. * Patients must be fluent in (speaking, reading) English after consenting into protocol 01-M-0254 as determined through clinical judgement. --This study uses English-language manualized PMT. The PMT intervention materials, digital tool, therapist and rater training and supervision procedures, fidelity ratings, and outcome measures are currently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Enrolling non-English speakers can introduce a confound to our research objectives around feasibility, symptom and behavior change, and acceptability and fidelity. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors. * At least one parent or guardian of the minor subject must be willing to enroll in the protocol and have the cognitive ability to consent. * The minor subject must be able understand a written assent document as determined through clinical judgement, as well as be willing to sign a written assent document. Inclusion Criteria for Parent or Guardian: To be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria: * Enrollment into 01-M-0254 for screening purposes * Parent or guardian of a child eligible for this protocol that can attend 12 PMT sessions and is willing to use the digital tool * Fluent in English after consenting into protocol 01-M-0254 as determined through clinical judgement * Ability of parent or guardian to understand the consent form and the willingness to sign a written informed consent document EXCLUSION CRITERIA: Exclusion Criteria for Youth: All screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation. * Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments * IQ \< 70 * Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data. Exclusion Criteria for Parent or Guardian: All screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation. * IQ \< 70 as assessed via a neuropsychological assessment or via assessment by trained clinical staff * Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis. * Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment but not including self-help groups).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

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