NCT07812948

Brief Summary

Attention deficit hyperactivity disorder (ADHD) is a common condition that affects children's behaviour, attention and activity levels. Medicines can be an effective treatment for ADHD, but it is often difficult to know which medicine will work best for a particular child. As a result, some children may need to try several medicines before finding one that is effective and well tolerated. This study aims to test a new online decision-support system called PETRA. The system is designed to help children, parents or carers, and doctors make shared decisions about ADHD medication. The study will assess whether it is practical and acceptable to run a larger clinical trial comparing this personalised approach with standard care.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Sep 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Nov 2028

First Submitted

Initial submission to the registry

August 14, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

September 10, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

August 14, 2026

Last Update Submit

September 4, 2026

Conditions

ADHD

Outcome Measures

Primary Outcomes (4)

  • Acceptability of PETRA decision-aid tool

    measured using a qualitative interview shortly after the first medication appointment

    Enrolment to approximately 24 weeks

  • Recruitment Rate

    measured using trial database at the end of study

    Enrolment to approximately 24 weeks

  • Withdrawal rates

    Measured using trial database at the end of the study

    Enrolment to approximately 24 weeks

  • Data completeness

    Measured using trial database at the end of the study

    Enrolment to approximately 24 weeks

Study Arms (3)

PETRA decision-support tool

EXPERIMENTAL
Other: PETRA decision-aid tool

Best-evidence decision-support tool

ACTIVE COMPARATOR
Other: Best-evidence decision-support tool

Standard practice

NO INTERVENTION

Interventions

PETRA decision-aid toolOTHER

The PETRA decision-aid tool will use personalised data as well as data from meta-analysis to provide three best choices of ADHD medication. This will aid shared decision-making between clinician and patient.

PETRA decision-support tool
Best-evidence decision-support toolOTHER

The output for this arm will look the same as the PETRA tool, providing three top choices of medication, each with respective pros and cons and margin of statistical uncertainty. However, the output of this tool will instead indicate the side effects that any medication is likely to cause, or not cause, based on population average data, regardless of the patients' individual characteristics.

Best-evidence decision-support tool

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children/adolescents:
  • Aged 6-17 years
  • With a clinical diagnosis of ADHD by a clinical team (using either DSM-5-TR or ICD-11 criteria)
  • On the waiting list for the pharmacological treatment of ADHD
  • Parental responsibility
  • Knowledge of child's medical history sufficient to complete assessments.
  • Access to internet and email
  • Able to give valid informed consent
  • Sufficient understanding of English to allow access/understanding of the PETRA decision support system and study documentation

You may not qualify if:

  • Based on the clinical judgement of the prescribing clinician, any current condition that would be a contraindication for ADHD medication, including abnormal cardiovascular examination (i.e., BP\>95th percentile (for stimulants) and low blood pressure for guanfacine/clonidine as well as tachycardia ) or any conditions that should be treated before starting pharmacological treatment for ADHD such as alcohol/substance dependence, active psychosis, and active mania
  • Immediate risk to self or others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2026

First Posted

September 10, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

September 10, 2026

Record last verified: 2026-08