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

Uppsala University

Status: Enrolling

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Procedure: Brief assessment protocol; Procedure: Comprehensive assessment protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05588713

467830400

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Brief assessment protocol

Other group

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.

Treatment:

Procedure: Brief assessment protocol

Comprehensive assessment protocol

Other group

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.

Treatment:

Procedure: Comprehensive assessment protocol