Attention Deficit Hyperactivity DisorderNCT05588713
A Systematic Study of Assessment of Attention-Deficit/Hyperactivity Disorder (ADHD)
A study testing Brief assessment protocol and Comprehensive assessment protocol in people with Attention Deficit Hyperactivity Disorder, run by Uppsala University at 1 site in Sweden.
Trial summary
ADHD is one of the most prevalent psychiatric conditions, consuming a large proportion of resources in psychiatric care, often accompanied by long waiting lists to receive proper assessment. The number of ADHD cases has increased, possible due to heightened awareness of the condition. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Brief assessment protocol and Comprehensive assessment protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2023to 4 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-17 years
- Referral for ADHD assessment
Who cannot join
- Suspected intellectual disability
- Substance abuse
- Psychosis
- Severe depression
- Parent not fluent in Swedish
- Child not living with legal guardian
- Child having protected identity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Systematic Study of ADHD Assessments Within Child and Adolescent Psychiatric Care
ADHD is one of the most prevalent psychiatric conditions, consuming a large proportion of resources in psychiatric care, often accompanied by long waiting lists to receive proper assessment. The number of ADHD cases has increased, possible due to heightened awareness of the condition. There are large prevalence differences, potentially due to variations in assessments procedures. Many clinicians and parents view the diagnostic process as too extensive, taking time from treatment and interventions. In addition, assessments may be perceived as too focused on diagnostic criteria to be fully helpful. Systematic research on how assessment procedures can be optimized is essentially lacking. It is largely unknown whether brief protocols including medical history, diagnostic interview, and rating scales differ from comprehensive protocols that also encompass neuropsychological testing regarding validity, reliability, patient satisfaction and cost-effectiveness. Further, feasible biomarkers (e.g. heart rate variability, pupil dilation and the pupillary light reflex) of the autonomic nervous system have been proposed as indicators of diagnostic status. The aim of this study is to gain knowledge about diagnostic processes to enable valid, reliable, and cost-effective ADHD assessments. Using a randomized controlled trial design (N = 140 children, 8-17 years, referred to child and adolescent psychiatric units), differences between a brief and a comprehensive ADHD assessment protocol regarding assessment outcome, reliability, validity, patient satisfaction, and future outcome taking gender into account will be examined. The investigators will explore diagnostic sensitivity and specificity of the included assessment instruments and estimate cost-effectiveness of the brief and comprehensive protocols to enable policy makers to make informed decisions. The project will provide important knowledge for patients and clinicians, and inform our understanding of mechanisms underpinning ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Brief assessment protocol, Comprehensive assessment protocol
- Keywords
- Assessment, Biomarkers, Patient satisfaction, Validity, Reliability
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief assessment protocolProcedure or surgery
The intervention constitutes of a brief assessment protocol for assessing ADHD.
Comprehensive assessment protocolProcedure or surgery
The intervention constitutes of a comprehensive assessment protocol for assessing ADHD.
| Study group | Role | What they receive |
|---|---|---|
| Brief assessment protocol | Other | The brief protocol will contain a minimum according to guidelines for assessing ADHD:
review of medical records, a validated diagnostic interview (MINI-KID), a structured medical history, a pedagogical statement including suspicion of intellectual disability, and rating scales for symptoms such as ADHD, oppositional defiant disorder, autism, anxiety, and depression directed to children (≥ 13 years), parents, and teachers. Receives: Procedure: Brief assessment protocol |
| Comprehensive assessment protocol | Other | The comprehensive protocol will extend the brief protocol by adding an approximately three-hour long battery of neuropsychological tests (WISC-V and CPT 3) and biomarkers (heart-rate variability, pupil dilation and the pupillary light reflex) assessed during the CPT 3. Receives: Procedure: Comprehensive assessment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in assessment duration between the two protocols
Numbers of initiated hours to complete the assessments
Measured: Immediately after completion of assessment
Difference in prevalence of assigned diagnoses between the two protocols
Proportion of ADHD diagnoses (including presentation) and comorbid diagnoses
Measured: Immediately after completion of assessment
Difference in assessor certainty between the two protocols
The certainty score will be assigned by the assessor on a 1 to 10-point scale, where 6 to 10 index the assessor's degree of certainty of the child meeting criteria for ADHD and 1 to 5 the assessor's certainty of the child not meeting criteria for ADHD
Measured: Immediately after completion of assessment
Difference in reliability between the two protocols
A second assessor will review the assessment material (blind to diagnostic status) and assign diagnostic status to each case. S/he will be given all information included in the assessment, except for diagnostic status and asked to assign diagnosis/es as well as a certainty score on a 1 to 10-point scale, where 6 to 10 index the assessor's degree of certainty of the child meeting criteria for ADHD and 1 to 5 the assessor's certainty of the child not meeting criteria for ADHD.
Measured: Immediately after completion of assessment
Difference in validity between the two protocols
An experienced clinician will assign diagnostic status using Longitudinal Expert All Data (LEAD; i.e. review of all available material) roughly one year post assessment, after follow-up data has been collected. For this purpose, all available material will include information included in the assessment, medical records following the assessment, and symptom ratings at follow up. S/he will assign diagnosis/es and a certainty score (on a 1 to 10-point scale, where 6 to 10 index the assessor's degree of certainty of the child meeting criteria for ADHD and 1 to 5 the assessor's certainty of the child not meeting criteria for ADHD), blind to original diagnostic status.
Measured: 1 year after completion of assessment
Difference in patient satisfaction between the two protocols
Children (> 13 years) and all legal guardians will rate satisfaction with the assessment process right after the assessment, using a satisfaction scale ranging from 1 to 5, where 5 indicates high satisfaction with the assessment.
Measured: Immediately after completion of assessment
Difference in patient satisfaction between the two protocols at follow-up
Children (> 13 years) and all legal guardians will rate satisfaction with the assessment process at follow up, using a satisfaction scale ranging from 1 to 5, where 5 indicates high satisfaction with the assessment.
Measured: 1 year after completion of assessment
Difference in cost effectiveness between the two protocols
To enable cost-effectiveness analyses, a health economist will build a model based on the following: Child (> 13 years) and parent ratings of child quality of life at baseline and follow-up using the Child Health Utility D9 (CHUD-9), on a scale from 1 to 5, where 1 indicates high quality of life. CHUD-9 will be used to estimate quality adjusted life years (QALYs). Personnel resources and overheads will be estimated for each protocol, and other inputs (such as risks of negative school outcomes and related costs, as well as costs related to ADHD treatment) will be collected from the literature. Consumption of healthcare and school resources for children, as well as productivity losses associated with absenteeism and presentism at school will be estimated from the Treatment Inventory of Costs in Patients (TIC-P), which will be filled out by the caregivers and teachers.
Measured: 1 year after completion of assessment
Secondary outcomes (7)
Sensitivity and specificity of the diagnostic interview in relation to ADHD diagnosis
Discriminative validity (positive predictive value, sensitivity, specificity, and area under the curve) will be calculated for the diagnostic interview, Mini Internationell Neuropsykiatrisk Intervju (MINI-kid), using formal diagnosis as the external criterion.
Measured: At baseline
Sensitivity and specificity of the ADHD-symptom rating scale in relation to ADHD diagnosis
Discriminative validity (positive predictive value, sensitivity, specificity, and area under the curve) will be calculated for the Adult ADHD Self-Report Scale Adolescent version (ASRS-A), in which symptoms are rated on a scale from 1-5, where 5 indicate high symptoms, with formal diagnosis as the external criterion.
Measured: At baseline
Sensitivity and specificity of workning memory in relation to ADHD diagnosis
Discriminative validity (positive predictive value, sensitivity, specificity, and area under the curve) will be calculated for the working memory index from Wechlser Intelligence Scale for Children (WISC-V), on a scale from 1 to 19, where 19 indicated high ability for workning memory. Formal diagnosis will be used as the external criterion.
Measured: At baseline
Sensitivity and specificity of Continous Performance Test in relation to ADHD diagnosis
Discriminative validity (positive predictive value, sensitivity, specificity, and area under the curve) will be calculated for the Conners Continous Performance Test (CPT-3). The CPT-3 renders a T-score ranging from 0-100, where 50 is the mean and 15 the standard diviation. Higher scores indicate better attention abilities. Formal diagnosis will be used as the external criterion.
Measured: At baseline
Sensitivity and specificity of heart rate variability in relation to ADHD diagnosis
Discriminative validity (positive predictive value, sensitivity, specificity, and area under the curve) will be calculated for heart rate variability assessed during the Conners Continous Performance Test (CPT-3). Formal diagnosis will be used as the external criterion.
Measured: At baseline
Sensitivity and specificity of pupil dilation in relation to ADHD diagnosis
Discriminative validity (positive predictive value, sensitivity, specificity, and area under the curve) will be calculated for pupil dilation assessed with an eye-tracker during the Conners Continous Performance Test (CPT-3). Formal diagnosis will be used as the external criterion.
Measured: At baseline
Sensitivity and specificity of the pupillary light reflex in relation to ADHD diagnosis
Discriminative validity (positive predictive value, sensitivity, specificity, and area under the curve) will be calculated for the pupillary light reflex. Formal diagnosis will be used as the external criterion.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Feb 2023
- Primary completion4 Jun 2025
- Study completion4 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will receive a brief assessment protocol and Group B will receive a comprehensive assessment protocol.
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
- Investigators
- Matilda Frick, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588713
- Sponsor's protocol ID
- 467830400
- Status last verified
- Jun 2026
- First submitted
- 28 Sep 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Study of ADHD Assessments Within Child and Adolescent Psychiatric Care
- ClinicalTrials.gov ID
- NCT05588713
- Acronym / sponsor ID
- 467830400
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Assessment, Biomarkers, Patient satisfaction, Validity, Reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 20 Oct 2022 (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.
ADHD is one of the most prevalent psychiatric conditions, consuming a large proportion of resources in psychiatric care, often accompanied by long waiting lists to receive proper assessment. The number of ADHD cases has increased, possible due to heightened awareness of the condition. There are large prevalence differences, potentially due to variations in assessments procedures. Many clinicians and parents view the diagnostic process as too extensive, taking time from treatment and interventions. In addition, assessments may be perceived as too focused on diagnostic criteria to be fully helpful. Systematic research on how assessment procedures can be optimized is essentially lacking. It is largely unknown whether brief protocols including medical history, diagnostic interview, and rating scales differ from comprehensive protocols that also encompass neuropsychological testing regarding validity, reliability, patient satisfaction and cost-effectiveness. Further, feasible biomarkers (e.g. heart rate variability, pupil dilation and the pupillary light reflex) of the autonomic nervous system have been proposed as indicators of diagnostic status. The aim of this study is to gain knowledge about diagnostic processes to enable valid, reliable, and cost-effective ADHD assessments. Using a randomized controlled trial design (N = 140 children, 8-17 years, referred to child and adolescent psychiatric units), differences between a brief and a comprehensive ADHD assessment protocol regarding assessment outcome, reliability, validity, patient satisfaction, and future outcome taking gender into account will be examined. The investigators will explore diagnostic sensitivity and specificity of the included assessment instruments and estimate cost-effectiveness of the brief and comprehensive protocols to enable policy makers to make informed decisions. The project will provide important knowledge for patients and clinicians, and inform our understanding of mechanisms underpinning ADHD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A will receive a brief assessment protocol and Group B will receive a comprehensive assessment protocol.
| Arm | Type | Receives |
|---|---|---|
| Brief assessment protocol | Other | Procedure: Brief assessment protocolThe brief protocol will contain a minimum according to guidelines for assessing ADHD: review of medical records, a validated diagnostic interview (MINI-KID), a structured medical history, a pedagogical statement including suspicion of intellectual disability, and rating scales for symptoms such as ADHD, oppositional defiant disorder, autism, anxiety, and depression directed to children (≥ 13 years), parents, and teachers. |
| Comprehensive assessment protocol | Other | Procedure: Comprehensive assessment protocolThe comprehensive protocol will extend the brief protocol by adding an approximately three-hour long battery of neuropsychological tests (WISC-V and CPT 3) and biomarkers (heart-rate variability, pupil dilation and the pupillary light reflex) assessed during the CPT 3. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 8-17 years
- Referral for ADHD assessment
Key exclusion criteria (7 listed)
- Suspected intellectual disability
- Substance abuse
- Psychosis
- Severe depression
- Parent not fluent in Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief assessment protocolThe intervention constitutes of a brief assessment protocol for assessing ADHD. | Procedure or surgery | Brief assessment protocol |
| Comprehensive assessment protocolThe intervention constitutes of a comprehensive assessment protocol for assessing ADHD. | Procedure or surgery | Comprehensive assessment protocol |
Primary outcome
Difference in assessment duration between the two protocols
Time frame: Immediately after completion of assessment
Numbers of initiated hours to complete the assessments
Difference in prevalence of assigned diagnoses between the two protocols
Time frame: Immediately after completion of assessment
Proportion of ADHD diagnoses (including presentation) and comorbid diagnoses
Difference in assessor certainty between the two protocols
Time frame: Immediately after completion of assessment
The certainty score will be assigned by the assessor on a 1 to 10-point scale, where 6 to 10 index the assessor's degree of certainty of the child meeting criteria for ADHD and 1 to 5 the assessor's certainty of the child not meeting criteria for ADHD
Difference in reliability between the two protocols
Time frame: Immediately after completion of assessment
A second assessor will review the assessment material (blind to diagnostic status) and assign diagnostic status to each case. S/he will be given all information included in the assessment, except for diagnostic status and asked to assign diagnosis/es as well as a certainty score on a 1 to 10-point scale, where 6 to 10 index the assessor's degree of certainty of the child meeting criteria for ADHD and 1 to 5 the assessor's certainty of the child not meeting criteria for ADHD.
Difference in validity between the two protocols
Time frame: 1 year after completion of assessment
An experienced clinician will assign diagnostic status using Longitudinal Expert All Data (LEAD; i.e. review of all available material) roughly one year post assessment, after follow-up data has been collected. For this purpose, all available material will include information included in the assessment, medical records following the assessment, and symptom ratings at follow up. S/he will assign diagnosis/es and a certainty score (on a 1 to 10-point scale, where 6 to 10 index the assessor's degree of certainty of the child meeting criteria for ADHD and 1 to 5 the assessor's certainty of the child not meeting criteria for ADHD), blind to original diagnostic status.
Difference in patient satisfaction between the two protocols
Time frame: Immediately after completion of assessment
Children (> 13 years) and all legal guardians will rate satisfaction with the assessment process right after the assessment, using a satisfaction scale ranging from 1 to 5, where 5 indicates high satisfaction with the assessment.
Difference in patient satisfaction between the two protocols at follow-up
Time frame: 1 year after completion of assessment
Children (> 13 years) and all legal guardians will rate satisfaction with the assessment process at follow up, using a satisfaction scale ranging from 1 to 5, where 5 indicates high satisfaction with the assessment.
Difference in cost effectiveness between the two protocols
Time frame: 1 year after completion of assessment
To enable cost-effectiveness analyses, a health economist will build a model based on the following: Child (> 13 years) and parent ratings of child quality of life at baseline and follow-up using the Child Health Utility D9 (CHUD-9), on a scale from 1 to 5, where 1 indicates high quality of life. CHUD-9 will be used to estimate quality adjusted life years (QALYs). Personnel resources and overheads will be estimated for each protocol, and other inputs (such as risks of negative school outcomes and related costs, as well as costs related to ADHD treatment) will be collected from the literature. Consumption of healthcare and school resources for children, as well as productivity losses associated with absenteeism and presentism at school will be estimated from the Treatment Inventory of Costs in Patients (TIC-P), which will be filled out by the caregivers and teachers.
7 secondary outcomes
Sensitivity and specificity of the diagnostic interview in relation to ADHD diagnosis
Time frame: At baseline
Sensitivity and specificity of the ADHD-symptom rating scale in relation to ADHD diagnosis
Time frame: At baseline
Sensitivity and specificity of workning memory in relation to ADHD diagnosis
Time frame: At baseline
Sensitivity and specificity of Continous Performance Test in relation to ADHD diagnosis
Time frame: At baseline
Sensitivity and specificity of heart rate variability in relation to ADHD diagnosis
Time frame: At baseline
Sensitivity and specificity of pupil dilation in relation to ADHD diagnosis
Time frame: At baseline
Sensitivity and specificity of the pupillary light reflex in relation to ADHD diagnosis
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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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. This study is not recruiting at the moment.
Matilda Frick, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief assessment protocol and Comprehensive assessment protocol in people with Attention Deficit Hyperactivity Disorder, run by Uppsala University at 1 site in Sweden.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 8 Jun 2026. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in assessment duration between the two protocols (time frame: Immediately after completion of assessment). The study lists 8 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 8 Jun 2026.