Attention Deficit Hyerpactivity DisorderART-transitionNCT07228650
ADHD Remote Technology and ADHD Transition: Predicting and Preventing Negative Outcomes
An observational study of Attention Deficit Hyerpactivity Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 17 years
- Conditions the study is for
- Attention Deficit Hyerpactivity Disorder
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Feb 2025to Apr 2028
- Phase
- Observational
- 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 16 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Community and secondary care clinics
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London
Aislinn Bowler, PhD, 07503926683, art-transition@kcl.ac.uk
aislinnbowler@gmail.com
About this study
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.
- Conditions
- Attention Deficit Hyerpactivity Disorder
- Keywords
- ADHD, attention-deficit/hyperactivity disorder, remote measurement technology, mHealth, Adolescence, medication adherence, Longitudinal
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with ADHD | Not described | |
| Informant | Parent or guardian of the individuals with ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms and functional impairment
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').
Measured: Baseline and every 4 weeks up to month 24
ADHD symptoms
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).
Measured: Baseline and every day up to month 24
Anxiety (General Anxiety Disorder-7, GAD-7)
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.
Measured: Baseline and every 4 weeks up to month 24
Depression (Patient Health Questionnaire -8, PHQ-8, adapted)
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.
Measured: Baseline and every 4 weeks up to month 24
Aggression (Reactive-Proactive Aggression Questionnaire for Adults. RPQ-A, adapted)
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.
Measured: Baseline and every 4 weeks up to month 24
Irritability - (Affective Reactivity Index self-report, ARI-s, adapted)
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.
Measured: Baseline and every 4 weeks up to month 24
Nicotine Dependence - The Fagerstrom Test for Nicotine Dependence
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.
Measured: Baseline and every 4 weeks up to month 24
Alcohol Use (Alcohol Use Disorders Identification Test questionnaire, AUDIT)
10 items, with a 4-point Likert scale rated from 0 to 3. A higher score is associated with more harmful or hazardous drinking.
Measured: Baseline and every 4 weeks up to month 24
Eating Disorders (Short Form of the Eating Disorder Examination Questionnaire, EDE-QS)
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.
Measured: Baseline and every 6 months up to month 24
Self-esteem (Rosenberg Self-Esteem Scale, RSES)
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.
Measured: Baseline and every 6 months up to month 24
Social support and engagement with work/studies
Non-validated questionnaire
Measured: Baseline and every 4 weeks up to month 24]
Healthy lifestyle behaviours and digital signals associated with changes in clinical symptoms
Passive monitoring using the RADAR-BASE smartphone "Passive App" measuring digital signals of behaviour.
Measured: Continuously across a 24-month time period
Healthy lifestyle behaviours and digital signals associated with changes in clinical symptoms
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.
Measured: Continuously across a 24-month time period
Healthy lifestyle behaviours and digital signals associated with changes in clinical symptoms
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.
Measured: Continuously across a 24-month time period
Markers associated with clinical symptoms - cognitive measures
Continuous Performance Test/Go No-Go Task (Combined Task)
Measured: Baseline and every 6 months up to month 24
Markers associated with clinical symptoms - cognitive measures
Fast Task
Measured: Baseline and every 6 months up to month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start17 Feb 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyerpactivity DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, South West London and St George's Mental Health NHS Trust, Northamptonshire Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Jonna Kuntsi, PhD, Principal investigator, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228650
- Sponsor's protocol ID
- 334427
- Acronym
- ART-transition
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not relevant
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADHD Remote Technology and ADHD Transition: Predicting and Preventing Negative Outcomes
- ClinicalTrials.gov ID
- NCT07228650
- Acronym / sponsor ID
- ART-transition / 334427
- Conditions
- Attention Deficit Hyerpactivity Disorder
- Keywords
- ADHD, attention-deficit/hyperactivity disorder, remote measurement technology, mHealth, Adolescence, medication adherence, Longitudinal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, South West London and St George's Mental Health NHS Trust, Northamptonshire Healthcare NHS Foundation Trust
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 14 Nov 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with ADHD | – | – |
| Informant | – | –Parent or guardian of the individuals with ADHD |
Who may qualify
- Ages
- 16 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Community and secondary care clinics
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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').
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).
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.
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.
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.
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.
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.
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.
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.
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.
Social support and engagement with work/studies
Time frame: Baseline and every 4 weeks up to month 24]
Non-validated questionnaire
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.
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.
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.
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)
Markers associated with clinical symptoms - cognitive measures
Time frame: Baseline and every 6 months up to month 24
Fast Task
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 26 Nov 2025.
- RADAR-base mobile-health platform developed by Dobson et al.Link provided by the sponsor.
- ADHD Remote Technology ('ART') assessment and monitoring assessments developed by Kuntsi, Dobson, et al.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Not relevant
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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.
Jonna Kuntsi, PhD principal investigator
Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyerpactivity Disorder, run by King's College London at 1 site in United Kingdom.
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 6 inclusion and 9 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 26 Nov 2025. 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 United Kingdom. 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 Aislinn Bowler, PhD (07503926683, art-transition@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD symptoms and functional impairment (time frame: Baseline and every 4 weeks up to month 24). The study lists 16 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 26 Nov 2025.