- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228650
ADHD Remote Technology and ADHD Transition: Predicting and Preventing Negative Outcomes (ART-transition)
November 20, 2025 updated by: King's College London
Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental condition affecting 5.9% of young people.
Late adolescence can be a particularly challenging period for young people with ADHD, with major life transitions, new demands and increased expectations.
This vulnerable phase also coincides with the transition from child and adolescent mental health care to adult ADHD services, where new UK data show that most young people with ADHD do not successfully transfer to adult services.
Therefore, many young people with ADHD do not receive appropriate interventions at a time when they may need them most.
Opportunities for intervention are currently not fully realised due to both the young people's disengagement from clinical services and our limited understanding of real-world targets for more holistic interventions.
The current study seeks to address these needs using remote (not in-person) measurement technology (RMT).
The MRC-funded project, ART-transition, will use the ADHD Remote Technology ('ART') assessment and monitoring assessments with young people with a diagnosis of ADHD aged 16-17 and the RADAR-base mobile-health platform to which it is linked.
ART consists of active (e.g.
questionnaires) and passive (e.g.
sleep) smartphone app monitoring.
In the study, the investigators will address three questions on the transition to adulthood for individuals with ADHD: what changes take place, what predicts them, and how can the investigators prevent negative outcomes and support healthy lifestyles?
The investigators will remotely monitor 250 young people with ADHD over two years.
The investigators will then co-design, with young people with ADHD, a prototype for a new ADHD-transition smartphone app.
Our approach focuses on giving young people with ADHD greater autonomy in how they manage their ADHD, in collaboration with their clinician, and places the emphasis on modifiable environmental factors and the prevention of negative outcomes.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aislinn Bowler, PhD
- Phone Number: 07503926683
- Email: art-transition@kcl.ac.uk
Study Locations
-
-
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London, United Kingdom
- Recruiting
- King's College London
-
Principal Investigator:
- Jonna Kuntsi, PhD
-
Contact:
- Aislinn Bowler, PhD
- Phone Number: 07503926683
- Email: art-transition@kcl.ac.uk
-
Contact:
- Email: aislinnbowler@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Community and secondary care clinics
Description
Inclusion Criteria:
- Diagnosis of DSM-5 ADHD
- Aged 16-17
- Able to give informed consent for participation
- Willing and able to complete self-reported assessments via smartphone
- Willing to use either their own compatible Android phone or a study Android - phone as their only smartphone during the data collection period
- Willing to wear the wearable device during the data collection period
Exclusion criteria
- Psychosis, currently experiencing a major depressive episode, mania, drug dependence in the last six months, or a major neurological disorder.
- Recent contact with psychiatric acute care (admission, crisis team or liaison team (A&E) in the last six months
- Any other major medical disease which might impact upon the patient's ability to participate in normal daily activities (e.g., due to hospitalisations)
- Pregnancy
- IQ < 70
Informant Inclusion Criteria:
- A parent or guardian, as chosen by the participant with ADHD
- Aged 18 or over
- Willing and able to complete web-based questionnaires regarding the participant with ADHD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Adolescents with ADHD
|
|
Informant
Parent or guardian of the individuals with ADHD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ADHD symptoms and functional impairment
Time Frame: Baseline and every 4 weeks up to month 24
|
Barkley Adult ADHD Rating scale on symptoms and functional impairment (BAARS-IV)- Self Report.
29 items.
For 18 items, individuals report the frequency with which they have experienced ADHD symptoms over the past two weeks on a four-point Likert Scale (0 = 'Never' or 'Rarely', 1 = 'Sometimes', 2 = 'Often', 3 = 'Very Often').
One item asks individuals to indicate the ages at which they first experienced symptoms.
For the final 10 items, individuals report the extent to which their symptoms have interfered with their ability to function in various domains (e.g., home life or at work) on a four-point Likert Scale (0 = 'Never or Rarely', 1 = 'Sometimes', 2 = 'Often', 3 = 'Very Often').
|
Baseline and every 4 weeks up to month 24
|
|
ADHD symptoms
Time Frame: Baseline and every day up to month 24
|
Non-validated daily ADHD symptom question. 1 item.
Individuals report the extent to which ADHD symptoms affected their daily activities on a Likert Scale (1 = Not at all, 2 = Slightly, 3 = Somewhat, 4 = Quite a lot, 5 = A lot).
|
Baseline and every day up to month 24
|
|
Anxiety (General Anxiety Disorder-7, GAD-7)
Time Frame: Baseline and every 4 weeks up to month 24
|
7-items.
4-point Likert scale indicating the frequency of experiencing items in the past two weeks (0 = 'Not at all', 1 = 'Several days', 2 = 'More than half the days', 3 = 'Nearly every day').
Higher scores indicate higher severity of anxiety symptoms.
|
Baseline and every 4 weeks up to month 24
|
|
Depression (Patient Health Questionnaire -8, PHQ-8, adapted)
Time Frame: Baseline and every 4 weeks up to month 24
|
8-items.
4-point Likert scale indicating the frequency of experiencing items in the past two weeks (0 = 'Not at all', 1 = 'Several days', 2 = 'More than half the days, 3 = 'Nearly every day').
Higher scores indicate higher severity of depression symptoms.
|
Baseline and every 4 weeks up to month 24
|
|
Aggression (Reactive-Proactive Aggression Questionnaire for Adults. RPQ-A, adapted)
Time Frame: Baseline and every 4 weeks up to month 24
|
23 items, 3-point Likert scale rated from 0 to 2 (0 = 'Never', 1 = 'Sometimes', 2 = 'Often'), indicating the frequency of experiencing items in the past two weeks.
Higher scores indicate increased aggression.
|
Baseline and every 4 weeks up to month 24
|
|
Irritability - (Affective Reactivity Index self-report, ARI-s, adapted)
Time Frame: Baseline and every 4 weeks up to month 24
|
7-item, 3-point Likert Scale rated from 0 to 3 (0 = 'Not True', 1 = 'Somewhat True', 2 = 'Certainly True') indicating frequency of experiencing symptoms in the past two weeks.
|
Baseline and every 4 weeks up to month 24
|
|
Nicotine Dependence - The Fagerstrom Test for Nicotine Dependence
Time Frame: Baseline and every 4 weeks up to month 24
|
6-items.
Four items are yes/no questions rated from 0 to 1, and two are multiple-choice questions rated from 0 to 3 on a 4-point Likert scale.
A higher score is associated with more nicotine dependence.
|
Baseline and every 4 weeks up to month 24
|
|
Alcohol Use (Alcohol Use Disorders Identification Test questionnaire, AUDIT)
Time Frame: Baseline and every 4 weeks up to month 24
|
10 items, with a 4-point Likert scale rated from 0 to 3. A higher score is associated with more harmful or hazardous drinking.
|
Baseline and every 4 weeks up to month 24
|
|
Eating Disorders (Short Form of the Eating Disorder Examination Questionnaire, EDE-QS)
Time Frame: Baseline and every 6 months up to month 24
|
12 items.
10 items are questions about behaviours in the past seven days, rated on a scale from 0 to 3 for frequency (0 = 0 days, 1 = 1-2 days, 2 = 3-5 days, 3 = 6-7 days). 2 items are about self-perception over the past seven days, rated on a scale from 0 to 3 for extent (0 = Not at all, 1 = Slightly, 2 = Moderately, 3 = Markedly).
A higher score is associated with more eating disorder behaviours.
|
Baseline and every 6 months up to month 24
|
|
Self-esteem (Rosenberg Self-Esteem Scale, RSES)
Time Frame: Baseline and every 6 months up to month 24
|
10 items.
4-point Likert scale format ('Strongly Agree', 'Agree', 'Disagree, 'Strongly Disagree').
Responses are assigned 1-4 points.
Higher scores indicate higher self-esteem.
|
Baseline and every 6 months up to month 24
|
|
Social support and engagement with work/studies
Time Frame: Baseline and every 4 weeks up to month 24]
|
Non-validated questionnaire
|
Baseline and every 4 weeks up to month 24]
|
|
Healthy lifestyle behaviours and digital signals associated with changes in clinical symptoms
Time Frame: Continuously across a 24-month time period
|
Passive monitoring using the RADAR-BASE smartphone "Passive App" measuring digital signals of behaviour.
|
Continuously across a 24-month time period
|
|
Healthy lifestyle behaviours and digital signals associated with changes in clinical symptoms
Time Frame: Continuously across a 24-month time period
|
Passive monitoring using a Fitbit wearable device measuring sleep.
Device sensors, including an accelerometer and a photoplethysmographic pulse oximeter, will be combined to calculate sleep duration.
|
Continuously across a 24-month time period
|
|
Healthy lifestyle behaviours and digital signals associated with changes in clinical symptoms
Time Frame: Continuously across a 24-month time period
|
Passive monitoring using a Fitbit wearable device measuring physical activity.
Device sensors, including a gyroscope and an accelerometer, will be combined to calculate step count.
|
Continuously across a 24-month time period
|
|
Markers associated with clinical symptoms - cognitive measures
Time Frame: Baseline and every 6 months up to month 24
|
Continuous Performance Test/Go No-Go Task (Combined Task)
|
Baseline and every 6 months up to month 24
|
|
Markers associated with clinical symptoms - cognitive measures
Time Frame: Baseline and every 6 months up to month 24
|
Fast Task
|
Baseline and every 6 months up to month 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonna Kuntsi, PhD, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Study Registration Dates
First Submitted
January 23, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Estimated)
November 14, 2025
Study Record Updates
Last Update Posted (Actual)
November 26, 2025
Last Update Submitted That Met QC Criteria
November 20, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 334427
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not relevant
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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