About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Behavioral Parent Training (BPT)
BehavioralEight (8) weekly online sessions of BPT
Behavioral Parent Training (BPT) + Support of AI app
Combination productEight (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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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).
Child Irritability (ARI)
Measured via the Affective Reactivity Index. Total score ranges from 0 to 12; higher scores indicate greater irritability
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.
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.
Other outcomes
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?"
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Sant Joan de Déu
Lead sponsor
Parente AI
Collaborator