ADHD Remote Technology and ADHD Transition: Predicting and Preventing Negative Outcomes (ART-transition)
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
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
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Principal Investigator:
- Jonna Kuntsi, PhD
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Contact:
- Aislinn Bowler, PhD
- Phone Number: 07503926683
- Email: art-transition@kcl.ac.uk
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Contact:
- Email: aislinnbowler@gmail.com
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
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Adolescents with ADHD
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Informant
Parent or guardian of the individuals with ADHD
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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ADHD symptoms and functional impairment
Time Frame: Baseline and every 4 weeks up to month 24
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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').
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Baseline and every 4 weeks up to month 24
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ADHD symptoms
Time Frame: Baseline and every day up to month 24
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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).
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Baseline and every day up to month 24
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Anxiety (General Anxiety Disorder-7, GAD-7)
Time Frame: Baseline and every 4 weeks up to month 24
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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.
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Baseline and every 4 weeks up to month 24
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Depression (Patient Health Questionnaire -8, PHQ-8, adapted)
Time Frame: Baseline and every 4 weeks up to month 24
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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.
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Baseline and every 4 weeks up to month 24
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Aggression (Reactive-Proactive Aggression Questionnaire for Adults. RPQ-A, adapted)
Time Frame: Baseline and every 4 weeks up to month 24
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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.
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Baseline and every 4 weeks up to month 24
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Irritability - (Affective Reactivity Index self-report, ARI-s, adapted)
Time Frame: Baseline and every 4 weeks up to month 24
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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.
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Baseline and every 4 weeks up to month 24
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Nicotine Dependence - The Fagerstrom Test for Nicotine Dependence
Time Frame: Baseline and every 4 weeks up to month 24
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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.
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Baseline and every 4 weeks up to month 24
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Alcohol Use (Alcohol Use Disorders Identification Test questionnaire, AUDIT)
Time Frame: Baseline and every 4 weeks up to month 24
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10 items, with a 4-point Likert scale rated from 0 to 3. A higher score is associated with more harmful or hazardous drinking.
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Baseline and every 4 weeks up to month 24
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Eating Disorders (Short Form of the Eating Disorder Examination Questionnaire, EDE-QS)
Time Frame: Baseline and every 6 months up to month 24
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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.
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Baseline and every 6 months up to month 24
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Self-esteem (Rosenberg Self-Esteem Scale, RSES)
Time Frame: Baseline and every 6 months up to month 24
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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.
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Baseline and every 6 months up to month 24
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Social support and engagement with work/studies
Time Frame: Baseline and every 4 weeks up to month 24]
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Non-validated questionnaire
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Baseline and every 4 weeks up to month 24]
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Healthy lifestyle behaviours and digital signals associated with changes in clinical symptoms
Time Frame: Continuously across a 24-month time period
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Passive monitoring using the RADAR-BASE smartphone "Passive App" measuring digital signals of behaviour.
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Continuously across a 24-month time period
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Healthy lifestyle behaviours and digital signals associated with changes in clinical symptoms
Time Frame: Continuously across a 24-month time period
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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.
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Continuously across a 24-month time period
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Healthy lifestyle behaviours and digital signals associated with changes in clinical symptoms
Time Frame: Continuously across a 24-month time period
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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.
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Continuously across a 24-month time period
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Markers associated with clinical symptoms - cognitive measures
Time Frame: Baseline and every 6 months up to month 24
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Continuous Performance Test/Go No-Go Task (Combined Task)
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Baseline and every 6 months up to month 24
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Markers associated with clinical symptoms - cognitive measures
Time Frame: Baseline and every 6 months up to month 24
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Fast Task
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Baseline and every 6 months up to month 24
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
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
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 334427
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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