Behavior Problem of Childhood and AdolescenceNCT07469215
Behavioral Parent Training With and Without AI Support for Children With Disruptive Behaviors
A study testing Behavioral Parent Training (BPT) and Behavioral Parent Training (BPT) + Support of AI app in people with Behavior Problem of Childhood and Adolescence and Parent Management Training, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Behavior Problem of Childhood and Adolescence, Parent Management Training, Artificial Intelligence (AI)
- What is being tested?
- Behavioral Parent Training (BPT) and Behavioral Parent Training (BPT) + Support of AI app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eduardo L Bunge, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Sant Joan de Déu
Barcelona, Barcelona, 08950
About this study
Official title: A Pilot Randomized Controlled Trial of Behavioral Parent Training (BPT) With or Without AI Support in Children With Disruptive Behaviors
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:
Read more
- 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.
Read the 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.
- Conditions
- Behavior Problem of Childhood and Adolescence, Parent Management Training, Artificial Intelligence (AI), Disruptive Behaviours, Irritability, Attention Deficit Disorder With Hyperactivity (ADHD)
- Being tested
- Behavioral Parent Training (BPT), Behavioral Parent Training (BPT) + Support of AI app
- Keywords
- Disruptive behaviors, Parent Management Training, Artifical intelligence, Irritability, Behavior problems, Attention Deficit Disorder with Hyperactivity (ADHD)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Problem Behavior, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Parent Training (BPT)Behavioural
Also called Parent Management Training (PMT)
Eight (8) weekly online sessions of BPT
Behavioral Parent Training (BPT) + Support of AI appCombination product
Also called AI-enhanced intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| BPT | Active comparator | 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.). Receives: Behavioral: Behavioral Parent Training (BPT) |
| BPT+AI app | Experimental | 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. Receives: Combination Product: Behavioral Parent Training (BPT) + Support of AI app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 6 months follow up
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.
Measured: Week 4 and 8 (Postreatment)
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.
Measured: Week 8 (Post-treatment)
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.
Measured: Week 4, Week 8 (Post-treatment), 3-month follow-up, and 6-month follow-up.
Treatment Attendance Rate
Percentage of group sessions attended. Calculated as (Sessions Attended / Total Sessions) x 100.
Measured: Through the end of the 8-week intervention
Study Dropout Rate
Percentage of participants who withdraw from the study or discontinue the intervention.
Measured: Week 8 (Post-treatment), 3-month follow-up, and 6-month follow-up.
Secondary outcomes (4)
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).
Measured: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up
Child Irritability (ARI)
Measured via the Affective Reactivity Index. Total score ranges from 0 to 12; higher scores indicate greater irritability
Measured: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up
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.
Measured: Baseline, Week 8 (Post-treatment), and 6-month follow-up
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.
Measured: Baseline, Week 8 (Post-treatment), and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior Problem of Childhood and AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Parente AI
- Responsible party
- Principal investigator, Pablo Vidal-Ribas Belil, Fundació Sant Joan de Déu
- Investigators
- Pablo Vidal-Ribas Belil, PhD, Principal investigator, Fundació de Recerca Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469215
- Sponsor's protocol ID
- PIC-172-25
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of Behavioral Parent Training (BPT) With or Without AI Support in Children With Disruptive Behaviors
- ClinicalTrials.gov ID
- NCT07469215
- Acronym / sponsor ID
- PIC-172-25
- Conditions
- Behavior Problem of Childhood and Adolescence, Parent Management Training, Artificial Intelligence (AI), Disruptive Behaviours, Irritability, Attention Deficit Disorder With Hyperactivity (ADHD)
- Keywords
- Disruptive behaviors, Parent Management Training, Artifical intelligence, Irritability, Behavior problems, Attention Deficit Disorder with Hyperactivity (ADHD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Parente AI
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BPT | Active comparator | Behavioral: Behavioral Parent Training (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.). |
| BPT+AI app | Experimental | Combination Product: Behavioral Parent Training (BPT) + Support of AI appParents 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Parent Training (BPT)Also: Parent Management Training (PMT)Eight (8) weekly online sessions of BPT | Behavioural | BPT |
| Behavioral Parent Training (BPT) + Support of AI appAlso: AI-enhanced interventionEight (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. | Combination product | BPT+AI app |
Primary outcome
Acceptability of AI support
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through the end of the 8-week intervention
Percentage of group sessions attended. Calculated as (Sessions Attended / Total Sessions) x 100.
Study Dropout Rate
Time frame: 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.
4 secondary outcomes
Child Disruptive Behavior (ECBI)
Time frame: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up
Child Irritability (ARI)
Time frame: Baseline, Week 4, Week 8, 3-month follow-up, and 6-month follow-up
Parental Psychological Distress (DASS-21)
Time frame: Baseline, Week 8 (Post-treatment), and 6-month follow-up
General Psychopathology and Impact (SDQ)
Time frame: Baseline, Week 8 (Post-treatment), and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Stress-related Problem, Stress, Emotional
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eduardo L Bunge, PhD contact
Pablo Vidal-Ribas Belil, PhD principal investigator
Fundació de Recerca Sant Joan de Déu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Parent Training (BPT) and Behavioral Parent Training (BPT) + Support of AI app in people with Behavior Problem of Childhood and Adolescence and Parent Management Training, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pablo Vidal-Ribas Belil, PhD (+34644890465, pablo.vidalribas@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of AI support (time frame: From enrollment to the end of treatment at 6 months follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.