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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorFundació Sant Joan de Déu

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Behavioral Parent Training (BPT)

    Behavioral

    Eight (8) weekly online sessions of BPT

  • Behavioral Parent Training (BPT) + Support of AI app

    Combination product

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: BPTActive comparator 1 intervention
Group B: BPT+AI appExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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)
3

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)
4

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.

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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)

Sponsors and contacts

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