- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06527508
Construct Validity and Intra-Observer Reliability of the SDQ
July 25, 2024 updated by: Hasan Bingöl, Bingol University
Construct Validity and Intra-Observer Reliability of the Self-Report Version of Strengths and Difficulties Questionnaire in Children With Cerebral Palsy
The aim of the observational study is to investigate the validity and reliability of a self-report version of the Strength and Difficulties Questionnaire (SDQ) for 11-17 years in children with cerebral palsy (CP).
That is, the current study explore if the self-report version of the SDQ would be valid and reliable in children with CP to report their mental health problems themself
Study Overview
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bingöl, Turkey, 12000
- Bingol University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
The study included children aged 11-17 years who were diagnosed with CP by health science boards at the government or education and research hospitals.
Description
Inclusion Criteria:
- A diagnosis of CP, a communication level of I-III on the Communication Function Classification System (CFCS), and no severe intellectual disability
Exclusion Criteria:
- the presence of an inability to comprehend items on the SDQ and involuntary attendance of a possible re-test after two weeks (i.e., for re-test reliability)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline in mental health on the 3-point Strength and Difficulties Questionnaire (SDQ) at 2 week
Time Frame: Baseline and Week 2
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The Strength and Difficulties Questionnaire (SDQ) was created by Goodman as a brief screening tool for assessing emotional and behavioral problems in children and adolescents.
There are two primary versions of the SDQ, self-report and proxy-report, for different age bands: 2-4, 11-17, 4-17 and over 18 years.
The SDQ consists of subscales for emotional problems, conduct problems, hyperactivity-inattention problems, peer problems, and prosocial scales.
Each subscale comprises five items, with 'somewhat true' being always scored as 1.
On the other hand, the scoring for 'not true' and 'certainly true' varied depending on the item (i.e., 0 or 2).
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Baseline and Week 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Downs J, Blackmore AM, Epstein A, Skoss R, Langdon K, Jacoby P, Whitehouse AJO, Leonard H, Rowe PW, Glasson EJ; Cerebral Palsy Mental Health Group. The prevalence of mental health disorders and symptoms in children and adolescents with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2018 Jan;60(1):30-38. doi: 10.1111/dmcn.13555. Epub 2017 Sep 15.
- Anthoine E, Moret L, Regnault A, Sebille V, Hardouin JB. Sample size used to validate a scale: a review of publications on newly-developed patient reported outcomes measures. Health Qual Life Outcomes. 2014 Dec 9;12:176. doi: 10.1186/s12955-014-0176-2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
May 15, 2024
Study Completion (Actual)
June 15, 2024
Study Registration Dates
First Submitted
July 25, 2024
First Submitted That Met QC Criteria
July 25, 2024
First Posted (Actual)
July 30, 2024
Study Record Updates
Last Update Posted (Actual)
July 30, 2024
Last Update Submitted That Met QC Criteria
July 25, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-33117789-044-167349
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.