Clinical trial NCT05588713: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Assessment
Biomarkers
Patient satisfaction
Validity
Reliability
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2022-10-20
Enrollment: 240
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A will receive a brief assessment protocol and Group B will receive a comprehensive assessment protocol.
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Difference in assessment duration between the two protocols
timeFrame: Immediately after completion of assessment
measure: Difference in prevalence of assigned diagnoses between the two protocols
timeFrame: Immediately after completion of assessment
measure: Difference in assessor certainty between the two protocols
timeFrame: Immediately after completion of assessment
measure: Difference in reliability between the two protocols
timeFrame: Immediately after completion of assessment
measure: Difference in validity between the two protocols
timeFrame: 1 year after completion of assessment
measure: Difference in patient satisfaction between the two protocols
timeFrame: Immediately after completion of assessment
measure: Difference in patient satisfaction between the two protocols at follow-up
timeFrame: 1 year after completion of assessment
measure: Difference in cost effectiveness between the two protocols
timeFrame: 1 year after completion of assessment
Secondary outcomes:
measure: Sensitivity and specificity of the diagnostic interview in relation to ADHD diagnosis
timeFrame: At baseline
measure: Sensitivity and specificity of the ADHD-symptom rating scale in relation to ADHD diagnosis
timeFrame: At baseline
measure: Sensitivity and specificity of workning memory in relation to ADHD diagnosis
timeFrame: At baseline
measure: Sensitivity and specificity of Continous Performance Test in relation to ADHD diagnosis
timeFrame: At baseline
measure: Sensitivity and specificity of heart rate variability in relation to ADHD diagnosis
timeFrame: At baseline
measure: Sensitivity and specificity of pupil dilation in relation to ADHD diagnosis
timeFrame: At baseline
measure: Sensitivity and specificity of the pupillary light reflex in relation to ADHD diagnosis
timeFrame: At baseline
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Child and adolescent psychiatry unit
Study officials:
affiliation: Uppsala University
name: Matilda Frick, PhD
role: PRINCIPAL_INVESTIGATOR
References: