Artificial Intelligence (AI), Attention Deficit Disorder With Hyperactivity (ADHD), Behavior Problem of Childhood and Adolescence, Disruptive Behaviours, Irritability, Parent Management Training
Conditions
Keywords
Disruptive behaviors, Parent Management Training, Artifical intelligence, Irritability, Behavior problems, Attention Deficit Disorder with Hyperactivity (ADHD)
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: 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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral Parent Training (BPT)
Eight (8) weekly online sessions of BPT
COMBINATION_PRODUCTBehavioral 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.
Sponsors
Fundació Sant Joan de Déu
Parente AI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of AI support | 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 | 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 | 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 | 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 | Through the end of the 8-week intervention | Percentage of group sessions attended. Calculated as (Sessions Attended / Total Sessions) x 100. |
| Study Dropout Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Child Disruptive Behavior (ECBI) | 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). |
| Child Irritability (ARI) | 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 |
| Parental Psychological Distress (DASS-21) | 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. |
| General Psychopathology and Impact (SDQ) | 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. |
Countries
Spain
Contacts
CONTACTPablo Vidal-Ribas Belil, PhD
CONTACTEduardo L Bunge, PhD
PRINCIPAL_INVESTIGATORPablo Vidal-Ribas Belil, PhD
Fundació de Recerca Sant Joan de Déu
Outcome results
None listed