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

NCT07469215 | Recruiting DMC

• 1 other identifier: PIC-172-25
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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:
• Standard BPT: Parents receive 8 weekly group training sessions (online).
• BPT plus ParenteAI: Parents receive the same 8 weekly sessions plus 24/7 access to an AI virtual assistant for personalized support.
• 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.

Conditions

Behavior Problem of Childhood and Adolescence; Parent Management Training; Artificial Intelligence (AI); Disruptive Behaviours; Irritability; Attention Deficit Disorder With Hyperactivity (ADHD)

Keywords

Disruptive behaviors; Parent Management Training; Artifical intelligence; Irritability; Behavior problems; Attention Deficit Disorder with Hyperactivity (ADHD)

Outcome Measures

Primary Outcomes (6)

• Acceptability of AI support

  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.

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

• Usefulness of BPT with or without AI support

  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.

  Week 4 and 8 (Postreatment)

• Satisfaction with AI application support

  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.

  Week 8 (Post-treatment)

• Therapeutic alliance with AI-assistant

  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.

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

• Treatment Attendance Rate

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

  Through the end of the 8-week intervention

• Study Dropout Rate

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

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

Secondary Outcomes (4)

• Child Disruptive Behavior (ECBI)

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

• Child Irritability (ARI)

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

• Parental Psychological Distress (DASS-21)

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

• General Psychopathology and Impact (SDQ)

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

Other Outcomes (1)

• Qualitative Feedback on AI application

  Week 8 (Post-treatment)

Study Arms (2)

BPT

ACTIVE COMPARATOR

Parents that receive 8 weekly online sessions of behavioral parent training (BPT). The program will include 8 sessions, including psychoeducation about goals and behaviors, special time, praise, clear instructions, rewards, active ignoring, cool down time, and school behavior. The BPT sessions are basedon a combination of the Module of conduct problems of the MATCH-ADCT program from Chorpita and Weisz (Modular Approach to Therapy for Children wit h Anxiety, Depression, Trauma, or Conduct Problems) (Chorpita \& Weisz, 2009), the BPT program from Russell A. Barkley (Barkley, R.A., 2013. Defiant children: A clinician's manual for assessment and parent training. Guilford press.), and the program from Alan E. Kazdin (Kazdin, A. E. (2005). Parent management training: Treatment for oppositional, aggressive, and antisocial behavior in children and adolescents. Oxford University Press.).

Behavioral: Behavioral Parent Training (BPT)

BPT+AI app

EXPERIMENTAL

Parents that receive 8 weekly online sessions of behavioral parent training (BPT) and have access to AI app 24/7. Parents will be given access to ParenteAI app and will be asked to open an account. When starting the app, they will be greeted by a therapist assistant called PAT (an AI agent) that will guide parents through different stages of BPT modules and ask any question they might have anytime anywhere in form of a chatbot. Specifically, the app has two dashboards: 1) A behavioral parent training divided in 8 core modules and several optional modules, in which PAT provides evidence-based manualized BPT, and that mirror the sessions from the BPT group. Parents using ParenteAI will work on each module the week before that topic is discussed in the BPT groups. 2) A chatbot with a curated knowledge base on BPT (trained on same manuales) where parents can talk and ask questions to PAT about anything related to parenting, providing specific feedback, 24/7.

Combination Product: Behavioral Parent Training (BPT) + Support of AI app

Interventions

Behavioral Parent Training (BPT) BEHAVIORAL

Eight (8) weekly online sessions of BPT

Also known as: Parent Management Training (PMT)

BPT

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.

Also known as: AI-enhanced intervention

BPT+AI app

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Parente AI: collaborator

Study Sites (1)

Hospital Sant Joan de Déu

Barcelona, Barcelona, 08950, Spain

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Problem Behavior; Mental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Pablo Vidal-Ribas Belil, PhD

  Fundació de Recerca Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Vidal-Ribas Belil, PhD

CONTACT

+34644890465; pablo.vidalribas@sjd.es

Eduardo L Bunge, PhD

CONTACT

pauvrb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ramón y Cajal Investigator

Model Details: It is an add-on trial, in which both parallel groups receive behavioral parent training, and one of the groups have also access to AI app.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

ES (1)