An interventional study of Behavioral Parent Training (BPT) and Behavioral Parent Training (BPT) + Support of AI app in Behavior Problem of Childhood and Adolescence, Parent Management Training and Artificial Intelligence (AI), sponsored by Fundació Sant Joan de Déu. Recruiting at 1 site in Spain. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Treatment
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:
Researchers will compare:
Participants will:
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's planned enrollment of 40 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Fundació Sant Joan de Déu is the lead sponsor of 70 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
Eight (8) weekly online sessions of BPT
Also known as: Parent Management Training (PMT)
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through the end of the 8-week intervention
Study Dropout Rate
Percentage of participants who withdraw from the study or discontinue the intervention.
Time frame: Week 8 (Post-treatment), 3-month follow-up, and 6-month follow-up.
Child Disruptive Behavior (ECBI)
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).
Time frame: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up
Child Irritability (ARI)
Measured via the Affective Reactivity Index. Total score ranges from 0 to 12; higher scores indicate greater irritability
Time frame: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up
Parental Psychological Distress (DASS-21)
Measured via the Depression, Anxiety, and Stress Scale. Evaluates negative emotional states across three subscales. Higher scores indicate greater distress.
Time frame: Baseline, Week 8 (Post-treatment), and 6-month follow-up
General Psychopathology and Impact (SDQ)
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.
Time frame: Baseline, Week 8 (Post-treatment), and 6-month follow-up
Qualitative Feedback on AI application
Open-ended assessment of parental experience using two questions: "What did you like the most?" and "What would you recommend improving?"
Time frame: Week 8 (Post-treatment)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Mar 2027, 11 months later.
Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 11 months is below that.
Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.
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