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Clinical Trials/NCT05588713
NCT05588713
Recruiting
N/A

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

Uppsala University1 site in 1 country240 target enrollmentFebruary 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Uppsala University
Enrollment
240
Locations
1
Primary Endpoint
Difference in validity between the two protocols
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
June 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 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 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 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 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 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.

Secondary Outcomes

  • Sensitivity and specificity of workning memory in relation to ADHD diagnosis(At baseline)
  • Sensitivity and specificity of heart rate variability in relation to ADHD diagnosis(At baseline)
  • Sensitivity and specificity of Continous Performance Test in relation to ADHD diagnosis(At baseline)
  • Sensitivity and specificity of the pupillary light reflex in relation to ADHD diagnosis(At baseline)
  • Sensitivity and specificity of the diagnostic interview in relation to ADHD diagnosis(At baseline)
  • Sensitivity and specificity of the ADHD-symptom rating scale in relation to ADHD diagnosis(At baseline)
  • Sensitivity and specificity of pupil dilation in relation to ADHD diagnosis(At baseline)

Study Sites (1)

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