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RecruitingNCT07469215

Behavioral Parent Training With and Without AI Support for Children With Disruptive Behaviors

A Pilot Randomized Controlled Trial of Behavioral Parent Training (BPT) With or Without AI Support in Children With Disruptive Behaviors

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Fundació Sant Joan de Déu · Academic / Other
Sex
All
Age
5 Years – 12 Years
Healthy volunteers
Not accepted

Summary

The goal of this clinical trial is to learn if adding an artificial intelligence (AI) application called to standard Behavioral Parent Training (BPT) helps families with children who have disruptive behavior problems. It will also help researchers understand if the app is easy to use and helpful for parents. The main question it aims to answer is: \- Is it feasible and acceptable for parents to use the AI app alongside their therapy sessions? The secondary questions it aims to answer are: * Does the app help reduce children's disruptive behaviors and irritability more than therapy alone? * Does using the app help lower stress, anxiety, and depression levels for the parents? Researchers will compare: 1. Standard BPT: Parents receive 8 weekly group training sessions (online). 2. BPT plus ParenteAI: Parents receive the same 8 weekly sessions plus 24/7 access to an AI virtual assistant for personalized support. Participants will: * Attend 8 weekly group training sessions. * Complete surveys about their child's behavior and their own well-being at baseline, after group training sessions 4 and 8, and 3 and 6 months after finalizing the group training. * If in the experimental group, use the ParenteAI app to get real-time coaching and support for managing their child's behavior at home. * Provide feedback on their experience and satisfaction with the program.

Detailed description

This study seeks to evaluate new ways to support families with children exhibiting disruptive behavior problems, one of the leading causes of referral to mental health services. Although Behavioral Parent Training (BPT) has proven to be a highly effective treatment, many children do not receive adequate care due to a lack of resources and overstretched services. Therefore, this project explores whether the use of the AI-based application can increase the efficacy and accessibility of BPT. Objectives: The primary objective is to examine the feasibility of adding the AI app to group-based BPT (acceptability, utility, satisfaction, therapeutic alliance, and attendance). As a secondary objective, the study will evaluate the clinical impact of the AI app in reducing disruptive behaviors and irritability in children, as well as decreasing symptoms of depression, anxiety, and stress in parents. Design: This is a randomized controlled trial with two conditions: (A) a control group, which will receive 8 weekly sessions of BPT (online) followed by treatment as usual for 6 months; and (B) an experimental group, which will receive the same BPT plus continuous access to the ParenteAI app, offering automated and personalized support via a 24/7 virtual assistant. Group assignment will be randomized using balanced blocks. Outcome Measures: Primary: Acceptability, utility (TAI), satisfaction (NPS), therapeutic alliance (WAI-SR), attendance, and dropout rates. Secondary: Disruptive behaviors (ECBI), irritability (ARI), parental symptoms of depression, anxiety, and stress (DASS-21), and general psychopathology (SDQ), in addition to sociodemographic data and clinical diagnoses. Qualitative assessments of the experience with ParenteAI will also be collected.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBehavioral Parent Training (BPT)Eight (8) weekly online sessions of BPT
COMBINATION_PRODUCTBehavioral Parent Training (BPT) + Support of AI appEight (8) weekly online sessions of BPT supported by AI app, with access 24/7 from baseline to 6 month follow up after last group session.

Timeline

Start date
2026-04-01
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2026-03-13
Last updated
2026-03-13

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07469215. Inclusion in this directory is not an endorsement.