ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000386336

Ethics application status

Approved

Date submitted

25/01/2026

Date registered

27/03/2026

Date last updated

27/03/2026

Date data sharing statement initially provided

27/03/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Integration of Artificial Intelligence into a Group-Based Parent Training Program: A Randomized Controlled Trial

Scientific title

Integration of Artificial Intelligence into a Group-Based Parent Training Program for Child Disruptive Behavior Problems: A Randomized Controlled Trial

Additional trial identifiers [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Disruptive behavior problems in children

Depression

Anxiety

Stress

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The intervention is an evidence-based, group-based online parent training program designed for caregivers of children aged 5 to 12 years presenting with disruptive behavior problems.

The program has a total duration of eight weeks and consists of weekly 90-minute synchronous group sessions facilitated by a licensed psychologist with formal training in cognitive-behavioral therapy and parent management training. Each group includes approximately 15 to 20 participants. All sessions are conducted via videoconference and are recorded, allowing participants to review the content if needed.

The intervention is based on a structured manual developed by the research team and adapted from Kazdin’s Parent Management Training model. The program includes the following modules:

Program introduction and goal setting

Special Time (relationship building and positive attention)

Praise and positive reinforcement

Reward systems / token economy

Effective instructions

Active ignoring

Logical consequences and time-out

Program consolidation and relapse prevention

Each session includes structured psychoeducation, therapist modeling of parenting skills, participant role-plays, group discussion, case-based problem solving, and weekly home practice assignments.

In addition to the synchronous group sessions, participants allocated to the intervention arm receive continuous (24/7) access during the eight-week program to “Parente,” a generative artificial intelligence–based conversational platform specialized in parent training.

Prior to each weekly session, participants are required to review structured psychoeducational modules delivered through the AI platform. The material covered asynchronously is subsequently integrated and expanded upon during the corresponding live group session.

The AI platform provides:

Psychoeducational content aligned with the intervention manual

Personalized examples of strategy implementation

Behavioral reformulation of parental instructions

Reminders and motivational support

Reinforcement of consistent strategy application

The platform does not provide clinical diagnosis, does not deliver individualized clinical prescriptions, and does not replace the role of the therapist. Its function is supportive and complementary between sessions.

Adherence to the intervention will be assessed through attendance records, total number of sessions completed, objective platform usage metrics (log-ins and interaction data), and therapist-monitored completion of weekly home practice tasks.

Intervention code [1]

Behaviour

Description of the comparator or control

Participants assigned to the control group receive a traditional evidence-based group parent training program delivered through weekly online sessions and facilitated by a psychologist, with content equivalent to that of the intervention group.

This group does not include integration of the artificial intelligence platform during the active intervention phase and therefore receives only the human-delivered component of the program, without additional digital support between sessions. The control group is implemented as a delayed access condition: participants will receive access to the artificial intelligence platform for a period of two months following completion of the group-based training program.

Control group

Active

Outcomes

Primary outcome [1]

Child disruptive behavior problems

Timepoint [1]

8 weeks post randomisation

Secondary outcome [1]

Parental depression

Timepoint [1]

8 weeks post randomisation

Secondary outcome [2]

Parental Anxiety

Timepoint [2]

8 weeks post randomisation

Secondary outcome [3]

Parental Stress

Timepoint [3]

8 weeks post randomisation

Eligibility

Key inclusion criteria

Mothers, fathers, or legal caregivers of children aged 5 to 12 years.

Caregivers of children with a diagnosis of Oppositional Defiant Disorder, Conduct Disorder, Intermittent Explosive Disorder, Attention-Deficit/Hyperactivity Disorder, and/or unspecified behavioral problems.

Being a user of the Psychological Care Center where the study is conducted.

Having access to an electronic device (computer, tablet, or smartphone) and regular internet access.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

Children with severe Autism Spectrum Disorder.

Children who are currently receiving concurrent psychological treatment.

Presence of self-injurious behaviors in the child.

Presence of psychotic symptoms in the child.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation concealment will be ensured through computer-generated randomisation conducted by an independent researcher not involved in participant eligibility assessment. Group assignment will be revealed only after completion of baseline assessment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The allocation sequence will be generated using computer-based permuted block randomisation with a 1:1 allocation ratio. Block sizes will be concealed from investigators to prevent prediction of group assignment.

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/04/2026

Actual

Date of last participant enrolment

Anticipated

30/11/2026

Actual

Date of last data collection

Anticipated

31/12/2026

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

Chile

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universidad Santo Tomás

Address [1]

Country [1]

Chile

Primary sponsor type

Other Collaborative groups

Name

Parente

Address

Country

United States of America

Secondary sponsor category [1]

University

Name [1]

Universidad Santo Tomás

Address [1]

Country [1]

Chile

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comité de Ética Científico de la Universidad Santo Tomás

Ethics committee address [1]

Ejército 146, Piso 6, Torre A Santiago 8320000. Región Metropolitana Chile

Ethics committee country [1]

Chile

Date submitted for ethics approval [1]

23/04/2025

Approval date [1]

19/06/2025

Ethics approval number [1]

Summary

Brief summary

This randomized controlled trial evaluates the effectiveness of integrating an artificial intelligence (AI)–based support tool into a structured, group-based parent training program for caregivers of children with behavioral difficulties. The primary objective is to assess whether the addition of AI support leads to greater reductions in child disruptive behavior compared to the standard parent training program alone. Secondary objectives include evaluating changes in parenting practices, caregiver psychological distress, therapeutic alliance, and treatment engagement.

It is hypothesized that participants allocated to the combined intervention (parent training plus AI support) will demonstrate greater improvements in primary and secondary outcomes compared to those receiving the standard program.

This study has been approved by the Scientific Ethics Committee of Universidad Santo Tomás (Chile) and will be conducted in accordance with national regulations and the Declaration of Helsinki. Written informed consent is obtained from all participants prior to enrolment. Participant confidentiality is maintained, and all data are stored securely in accordance with data protection standards.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Carlos Felipe Rivera Cepeda

Address

Universidad Santo Tomás, 18 de Septiembre 525 ,Temuco, 4780000, Región de La Araucanía

Country

Chile

Phone

+56959234131

Fax

[email protected]

Contact person for public queries

Name

Carlos Felipe Rivera Cepeda

Address

Universidad Santo Tomás, 18 de Septiembre 525 ,Temuco, 4780000, Región de La Araucanía

Country

Chile

Phone

+56959234131

Fax

[email protected]

Contact person for scientific queries

Name

Carlos Felipe Rivera Cepeda

Address

Universidad Santo Tomás, 18 de Septiembre 525 ,Temuco, 4780000, Región de La Araucanía

Country

Chile

Phone

+56959234131

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• De-identified individual participant data:
• All outcomes data
• Primary outcome(s)

What types of analyses could be done with individual participant data?

• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically