A Pilot Randomized Controlled Trial of Behavioral Parent Training (BPT) With or Without AI Support in Children With Disruptive Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability of AI support
研究概览
简要总结
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.
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
BPT
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.).
干预措施: Behavioral Parent Training (BPT) (Behavioral)
BPT+AI app
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.
干预措施: Behavioral Parent Training (BPT) + Support of AI app (Combination Product)
结局指标
主要结局
Acceptability of AI support
时间窗: 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.
Usefulness of BPT with or without AI support
时间窗: 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.
Satisfaction with AI application support
时间窗: 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.
Therapeutic alliance with AI-assistant
时间窗: 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.
Treatment Attendance Rate
时间窗: Through the end of the 8-week intervention
Percentage of group sessions attended. Calculated as (Sessions Attended / Total Sessions) x 100.
Study Dropout Rate
时间窗: 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.
次要结局
- 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)
研究者
Pablo Vidal-Ribas Belil
Ramón y Cajal Investigator
Fundació Sant Joan de Déu