Идёт набор NCT07469215

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

Без фазы С лечением Behavior Problem of Childhood and Adolescence Parent Management Training Artificial Intelligence (AI) Disruptive Behaviours

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Behavioral Parent Training (BPT), Behavioral Parent Training (BPT) + Support of AI app.
Кому может быть актуально: Состояния в реестре: Behavior Problem of Childhood and Adolescence, Parent Management Training, Artificial Intelligence (AI), Disruptive Behaviours. Базовые параметры: 5 лет — 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое Behavioral Parent Training (BPT)
Eight (8) weekly online sessions of BPT
Комбинированный продукт Behavioral Parent Training (BPT) + Support of AI app
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.

Первичные конечные точки

Acceptability of AI support [Срок оценки: From enrollment to the end of treatment at 6 months follow up]
Usefulness of BPT with or without AI support [Срок оценки: Week 4 and 8 (Postreatment)]
Satisfaction with AI application support [Срок оценки: Week 8 (Post-treatment)]
Therapeutic alliance with AI-assistant [Срок оценки: Week 4, Week 8 (Post-treatment), 3-month follow-up, and 6-month follow-up.]
Treatment Attendance Rate [Срок оценки: Through the end of the 8-week intervention]
Study Dropout Rate [Срок оценки: Week 8 (Post-treatment), 3-month follow-up, and 6-month follow-up.]

Вторичные конечные точки (4)

Child Disruptive Behavior (ECBI) [Срок оценки: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up]
Child Irritability (ARI) [Срок оценки: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up]
Parental Psychological Distress (DASS-21) [Срок оценки: Baseline, Week 8 (Post-treatment), and 6-month follow-up]
General Psychopathology and Impact (SDQ) [Срок оценки: Baseline, Week 8 (Post-treatment), and 6-month follow-up]

Критерии участия

Критерии включения

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.