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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Systematic Study of ADHD Assessments Within Child and Adolescent Psychiatric Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05588713
• Other study ID #: 467830400
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: Uppsala University
• Contact: Matilda Frick, PhD
• Phone: +46736942728
• Email: matilda.frick[@]neuro.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Procedure:
• Brief assessment protocol
The intervention constitutes of a brief assessment protocol for assessing ADHD.
• Comprehensive assessment protocol
The intervention constitutes of a comprehensive assessment protocol for assessing ADHD.

Locations

Country	Name	City	State
Sweden	Child and adolescent psychiatry unit	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Swedish Council for Working Life and Social Research

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in assessment duration between the two protocols	Numbers of initiated hours to complete the assessments	Immediately after completion of assessment
Primary	Difference in prevalence of assigned diagnoses between the two protocols	Proportion of ADHD diagnoses (including presentation) and comorbid diagnoses	Immediately after completion of assessment
Primary	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	Immediately after completion of assessment
Primary	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.	Immediately after completion of assessment
Primary	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.	1 year after completion of assessment
Primary	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.	Immediately after completion of assessment
Primary	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.	1 year after completion of assessment
Primary	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.	1 year after completion of assessment
Secondary	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.	At baseline
Secondary	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.	At baseline
Secondary	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.	At baseline
Secondary	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.	At baseline
Secondary	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.	At baseline
Secondary	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.	At baseline
Secondary	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.	At baseline