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Effect of Delayed-Release and Extended-Release Methylphenidate on Caregiver Strain and Validation of Psychometric Properties of the Caregiver Strain Questionnaire: Results from a Phase 3 Trial in Children with Attention-Deficit/Hyperactivity Disorder
- Source :
- Journal of Child and Adolescent Psychopharmacology
- Publication Year :
- 2021
- Publisher :
- Mary Ann Liebert, Inc., publishers, 2021.
-
Abstract
- Objectives: Inadequately controlled symptoms and associated impaired functioning have a significant negative impact on caregivers of children with attention-deficit/hyperactivity disorder (ADHD). This study aimed to assess the impact of evening-dosed, delayed-release and extended-release methylphenidate (DR/ER-MPH) treatment on caregiver strain, measured by the Caregiver Strain Questionnaire (CGSQ), and present post hoc psychometric analyses assessing the reliability and validity of the CGSQ, its ability to detect change (responsiveness), and to derive responder definitions. Methods: The CGSQ was an exploratory efficacy endpoint in a phase 3, 3-week, randomized, double-blind, multicenter, placebo-controlled, forced-dose titration trial of DR/ER-MPH in children aged 6–12 years with ADHD (NCT02520388). Psychometric properties of the CGSQ evaluated post hoc included internal consistency using Cronbach's alpha; test/retest reliability using intraclass correlation coefficients (ICCs); construct validity (known groups and convergent/divergent validity); responsiveness to changes in assessments of ADHD severity (ADHD Rating Scale-IV [ADHD-RS-IV], Conners' Global Index–Parent [CGI-P], and Clinical Global Impression—Severity [CGI-S]/CGI—Improvement [CGI-I]); and meaningful change threshold (MCT) using receiver operating characteristic curves, which were used to compare response between DR/ER-MPH and placebo groups. Results: Randomized DR/ER-MPH (54.5) and placebo (54.9) groups had similar mean CGSQ scores at screening. Caregivers of children on DR/ER-MPH reported significant reductions in CGSQ scores after 3 weeks of DR/ER-MPH treatment versus placebo (least-squares mean: 41.2 vs. 49.1; p
- Subjects :
- DR/ER-MPH
psychometrics
Male
Psychometrics
methylphenidate
Double-Blind Method
caregiver strain
Surveys and Questionnaires
mental disorders
medicine
Attention deficit hyperactivity disorder
Humans
Pharmacology (medical)
Child
validation
Methylphenidate
business.industry
Reproducibility of Results
Delayed release (linguistics)
Original Articles
medicine.disease
Psychiatry and Mental health
Treatment Outcome
Caregivers
Attention Deficit Disorder with Hyperactivity
Delayed-Action Preparations
Pediatrics, Perinatology and Child Health
Caregiver strain
HLD200
Central Nervous System Stimulants
Female
Extended release
business
Clinical psychology
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 15578992 and 10445463
- Volume :
- 31
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- Journal of Child and Adolescent Psychopharmacology
- Accession number :
- edsair.doi.dedup.....d7661850f1e24fec9f31efb9ca8892a5