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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group A will receive a brief assessment protocol and Group B will receive a comprehensive assessment protocol.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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Brief assessment protocol

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.

Group Type OTHER

Brief assessment protocol

Intervention Type PROCEDURE

The intervention constitutes of a brief assessment protocol for assessing ADHD.

Comprehensive assessment protocol

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.

Group Type OTHER

Comprehensive assessment protocol

Intervention Type PROCEDURE

The intervention constitutes of a comprehensive assessment protocol for assessing ADHD.

Interventions

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Brief assessment protocol

The intervention constitutes of a brief assessment protocol for assessing ADHD.

Intervention Type PROCEDURE

Comprehensive assessment protocol

The intervention constitutes of a comprehensive assessment protocol for assessing ADHD.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No