ADHD Remote Technology and ADHD Transition: Predicting and Preventing Negative Outcomes

NCT07228650 | Recruiting

• 1 other identifier: 334427
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (16)

• 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').

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline and every 6 months up to month 24

• Social support and engagement with work/studies

  Non-validated questionnaire

  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.

  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.

  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.

  Continuously across a 24-month time period

• Markers associated with clinical symptoms - cognitive measures

  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

  Fast Task

  Baseline and every 6 months up to month 24

Study Arms (2)

Adolescents with ADHD

Informant

Parent or guardian of the individuals with ADHD

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Community and secondary care clinics

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator
• South West London and St George's Mental Health NHS Trust: collaborator
• Northamptonshire Healthcare NHS Foundation Trust: collaborator

Study Sites (1)

King's College London

London, United Kingdom

RECRUITING

Related Links

• RADAR-base mobile-health platform developed by Dobson et al.
• ADHD Remote Technology ('ART') assessment and monitoring assessments developed by Kuntsi, Dobson, et al.

Biospecimen

Retention: SAMPLES WITH DNA

DNA saliva samples

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Medication Adherence

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jonna Kuntsi, PhD

  Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aislinn Bowler, PhD

CONTACT

07503926683; art-transition@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: November 14, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)