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NCT Number: NCT07469215

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

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.

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Key information

Conditions

Behavior Problem of Childhood and Adolescence Artificial Intelligence (AI) Attention Deficit Disorder With Hyperactivity (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Child Behavior Disruptive Behaviours Irritability Mental Disorders Neurodevelopmental Disorders Parent Management Training Problem Behavior

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Déu

Barcelona, 08950, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a primary caregiver with a child aged 5 to 12 years exhibiting disruptive behaviors (e.g., symptoms of ODD, CD, IED, ADHD, and/or unspecified behavioral problems).
  • Having access to an electronic device and regular internet access.
  • Stable concomitant intervention including medications throughout the study.
  • Speak Spanish or Catalan language.
  • Signed informed consent by parents or legal guardians of the child.

Exclusion criteria

  • Having ASD as primary diagnosis.
  • Psychosis, self-harming behaviors, severe mood disorder.
  • Known Intelligent quotient < 70
  • Caregivers and/or children receiving any concurrent psychological treatment.
  • No signing the informant consent.

Treatment and study plan

Behavioral Parent Training (BPT)

Behavioral

Eight (8) weekly online sessions of BPT

Other names: Parent Management Training (PMT)

Behavioral Parent Training (BPT) + Support of AI app

Combination Product

Eight (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.

Other names: AI-enhanced intervention

Primary outcomes

  1. Acceptability of AI support

    Time frame: From enrollment to the end of treatment at 6 months follow up

    This will be measured by the total number of modules completed, number of In-the-moment support interactions with ParenteAi initiated by parent, number of messages exchanged, words sent by the parent, and average words per message.

  2. Usefulness of BPT with or without AI support

    Time frame: Week 4 and 8 (Postreatment)

    This will be measured with the Therapy Attitude Inventory (TAI; Eyberg, 1993 Eyberg & Johnson, 1974). The TAI measures satisfaction with parent training, parent-child treatments, and family therapy. The scale consists of 10 items rated on a five-point Likert scale, with 1 indicating dissatisfaction or worsening of problems and 5 indicating maximum satisfaction or improvement. The total score ranges from 10 to 50.

  3. Satisfaction with AI application support

    Time frame: Week 8 (Post-treatment)

    This will be measured with the Net Promoter Score (NPS), a metric that measures the likelihood of parents, in this case, recommending the use of Parente.AI application to other parents with similar problems. The NPS is calculated by asking parents to rate, on a scale of 0 to 10, how likely they are to recommend. The score is then derived by subtracting the percentage of "detractors" (those who score 0-6) from the percentage of "promoters" (those who score 9-10). The resulting score ranges from -100 to +100.

  4. Therapeutic alliance with AI-assistant

    Time frame: Week 4, Week 8 (Post-treatment), 3-month follow-up, and 6-month follow-up.

    Therapeutic alliance with PAT (AI-assisted therapist) will be measured with the Working Alliance Inventory (WAI-SR). The WAI measures three important aspects of the therapeutic alliance: 1. Agreement about the therapeutic tasks, 2. Agreement about the therapeutic goals, and 3. The affective bond between clinician and client. The Working Alliance Inventory-Short Revised (WAI-SR) is a refined version designed to measure these key aspects with greater clarity and efficiency.

  5. Treatment Attendance Rate

    Time frame: Through the end of the 8-week intervention

    Percentage of group sessions attended. Calculated as (Sessions Attended / Total Sessions) x 100.

  6. Study Dropout Rate

    Time frame: Week 8 (Post-treatment), 3-month follow-up, and 6-month follow-up.

    Percentage of participants who withdraw from the study or discontinue the intervention.

Secondary outcomes

  1. Child Disruptive Behavior (ECBI)

    Time frame: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up

    The ECBI is a 36-item parent-report questionnaire used to assess the frequency and severity of disruptive behaviors in children aged 2-16. Parents rate each item on two scales; the intensity scale measures how frequently the behavior occurs on a 7-point Likert scale (1=never, 7=always), and the problem scales indicates whether the parent considers the behavior a problem (yes/no).

  2. Child Irritability (ARI)

    Time frame: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up

    Measured via the Affective Reactivity Index. Total score ranges from 0 to 12; higher scores indicate greater irritability

  3. Parental Psychological Distress (DASS-21)

    Time frame: Baseline, Week 8 (Post-treatment), and 6-month follow-up

    Measured via the Depression, Anxiety, and Stress Scale. Evaluates negative emotional states across three subscales. Higher scores indicate greater distress.

  4. General Psychopathology and Impact (SDQ)

    Time frame: Baseline, Week 8 (Post-treatment), and 6-month follow-up

    Measured via the Strengths and Difficulties Questionnaire. Total difficulties score ranges from 0 to 40; higher scores indicate greater emotional/behavioral problems. Includes an Impact supplement with scores ranging 0-10, higher scores indicate greater impairment.

Other outcomes

  1. Qualitative Feedback on AI application

    Time frame: Week 8 (Post-treatment)

    Open-ended assessment of parental experience using two questions: "What did you like the most?" and "What would you recommend improving?"

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo L Bunge, PhD

CONTACT

[email protected]

Pablo Vidal-Ribas Belil, PhD

CONTACT

[email protected]

+34644890465

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Parente AI

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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