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A Systematic Study of Assessment of Attention-Deficit/Hyperactivity Disorder (ADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Brief assessment protocol
Comprehensive assessment protocol
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Attention Deficit Hyperactivity Disorder focused on measuring Assessment, Biomarkers, Patient satisfaction, Validity, Reliability

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 8-17 years
  • Referral for ADHD assessment

Exclusion Criteria:

  • Suspected intellectual disability
  • Substance abuse
  • Psychosis
  • Severe depression
  • Parent not fluent in Swedish
  • Child not living with legal guardian
  • Child having protected identity

Sites / Locations

  • Child and adolescent psychiatry unitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Brief assessment protocol

Comprehensive assessment protocol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in assessment duration between the two protocols
Numbers of initiated hours to complete the assessments
Difference in prevalence of assigned diagnoses between the two protocols
Proportion of ADHD diagnoses (including presentation) and comorbid diagnoses
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
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 28, 2022
Last Updated
May 11, 2023
Sponsor
Uppsala University
Collaborators
Swedish Council for Working Life and Social Research
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1. Study Identification

Unique Protocol Identification Number
NCT05588713
Brief Title
A Systematic Study of Assessment of Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title
A Systematic Study of ADHD Assessments Within Child and Adolescent Psychiatric Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Swedish Council for Working Life and Social Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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 = 240 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Assessment, Biomarkers, Patient satisfaction, Validity, Reliability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A will receive a brief assessment protocol and Group B will receive a comprehensive assessment protocol.
Masking
None (Open Label)
Masking Description
Masking is not possible. The assessors that will review the material for reliability and validity purposes will be blind to diagnostic status of the participants.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief assessment protocol
Arm Type
Other
Arm Description
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.
Arm Title
Comprehensive assessment protocol
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Brief assessment protocol
Intervention Description
The intervention constitutes of a brief assessment protocol for assessing ADHD.
Intervention Type
Procedure
Intervention Name(s)
Comprehensive assessment protocol
Intervention Description
The intervention constitutes of a comprehensive assessment protocol for assessing ADHD.
Primary Outcome Measure Information:
Title
Difference in assessment duration between the two protocols
Description
Numbers of initiated hours to complete the assessments
Time Frame
Immediately after completion of assessment
Title
Difference in prevalence of assigned diagnoses between the two protocols
Description
Proportion of ADHD diagnoses (including presentation) and comorbid diagnoses
Time Frame
Immediately after completion of assessment
Title
Difference in assessor certainty between the two protocols
Description
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
Time Frame
Immediately after completion of assessment
Title
Difference in reliability between the two protocols
Description
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.
Time Frame
Immediately after completion of assessment
Title
Difference in validity between the two protocols
Description
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.
Time Frame
1 year after completion of assessment
Title
Difference in patient satisfaction between the two protocols
Description
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.
Time Frame
Immediately after completion of assessment
Title
Difference in patient satisfaction between the two protocols at follow-up
Description
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.
Time Frame
1 year after completion of assessment
Title
Difference in cost effectiveness between the two protocols
Description
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.
Time Frame
1 year after completion of assessment
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of the diagnostic interview in relation to ADHD diagnosis
Description
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.
Time Frame
At baseline
Title
Sensitivity and specificity of the ADHD-symptom rating scale in relation to ADHD diagnosis
Description
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.
Time Frame
At baseline
Title
Sensitivity and specificity of workning memory in relation to ADHD diagnosis
Description
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.
Time Frame
At baseline
Title
Sensitivity and specificity of Continous Performance Test in relation to ADHD diagnosis
Description
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.
Time Frame
At baseline
Title
Sensitivity and specificity of heart rate variability in relation to ADHD diagnosis
Description
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.
Time Frame
At baseline
Title
Sensitivity and specificity of pupil dilation in relation to ADHD diagnosis
Description
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.
Time Frame
At baseline
Title
Sensitivity and specificity of the pupillary light reflex in relation to ADHD diagnosis
Description
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.
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 8-17 years Referral for ADHD assessment Exclusion Criteria: Suspected intellectual disability Substance abuse Psychosis Severe depression Parent not fluent in Swedish Child not living with legal guardian Child having protected identity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matilda Frick, PhD
Phone
+46736942728
Email
matilda.frick@neuro.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Johan Isaksson, PhD
Email
johan.isaksson@neuro.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matilda Frick, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and adolescent psychiatry unit
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Isaksson, PhD
Email
johan.isaksson@neuro.uu.se

12. IPD Sharing Statement

Learn more about this trial

A Systematic Study of Assessment of Attention-Deficit/Hyperactivity Disorder (ADHD)

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