Clinical trial Recruiting at 1 site Observational Ages 8 to 13

Augmenting Parent Management Training with a Smartphone Tool

Official title: Augmenting Parent Management Training With Naturalistic Skills for Child Temper Outbursts Using a Digital Tool

Run by National Institutes of Health Clinical Center (CC) · NCT07764536 · Data updated 2026-11-12

This study tests whether adding a smartphone app to parent management training helps reduce irritability and temper outbursts in kids aged 8–13 with disruptive behavior disorders.

Quick facts

Study typeObservational
Ages8 Years to 13 Years
SexAll
Enrollment200 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedNovember 15, 2026
Main results expectedDecember 31, 2036
Study endsDecember 31, 2037
Registry record updatedNovember 10, 2026
Trial IDNCT07764536 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 8–13 with disruptive behavior disorders whose parents are willing to participate and have access to a smartphone.

Probably not a fit

Children whose families do not engage with PMT or the app may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study compares PMT plus a digital tool to PMT without the digital tool in 60 parent-child pairs. All participants receive 12 weekly PMT sessions, either in person or by video, with sessions recorded for fidelity. The digital tool is designed to help parents practice PMT skills in real life and during daily routines. The study uses EMA to track parenting behaviors and child irritability, aiming to see if the app enhances active ignoring and reduces outbursts. Primary outcomes focus on feasibility and changes in irritability and functioning, with secondary and tertiary aims exploring symptom changes and acceptability.

Why it matters

Potential benefit: If successful, the digital tool could help parents apply PMT more consistently and improve child behavior.

How similar studies have gone: Previous PMT studies show benefit for child behavior; adding a digital augmentation is a newer approach with potential but remains exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
* 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).

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.