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

NCT05588713 | Unknown

• 1 other identifier: 467830400
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Assessment; Biomarkers; Patient satisfaction; Validity; Reliability

Outcome Measures

Primary Outcomes (8)

• Difference in assessment duration between the two protocols

  Numbers of initiated hours to complete the assessments

  Immediately after completion of assessment

• Difference in prevalence of assigned diagnoses between the two protocols

  Proportion of ADHD diagnoses (including presentation) and comorbid diagnoses

  Immediately after completion of assessment

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• 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 workning memory 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 heart rate variability in relation to ADHD diagnosis

  At baseline

Study Arms (2)

Brief assessment protocol

OTHER

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.

Procedure: Brief assessment protocol

Comprehensive assessment protocol

OTHER

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.

Procedure: Comprehensive assessment protocol

Interventions

Brief assessment protocol PROCEDURE

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

Brief assessment protocol

Comprehensive assessment protocol PROCEDURE

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

Comprehensive assessment protocol

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-17 years
• Referral for ADHD assessment

You may not qualify if:

• Suspected intellectual disability
• Substance abuse
• Psychosis
• Severe depression
• Parent not fluent in Swedish
• Child not living with legal guardian
• Child having protected identity

Sponsors & Collaborators

• Uppsala University: lead
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (1)

Child and adolescent psychiatry unit

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Patient Satisfaction

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Matilda Frick, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matilda Frick, PhD

CONTACT

+46736942728; matilda.frick@neuro.uu.se

Johan Isaksson, PhD

CONTACT

johan.isaksson@neuro.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 20, 2022
• Study Start: February 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

SE (1)