Cerebral PalsyNCT06527508
Construct Validity and Intra-Observer Reliability of the SDQ
An observational study of Cerebral Palsy, run by Bingol University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Non-Interventional
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Child
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.
Who may be able to join
- A diagnosis of CP, a communication level of I-III on the Communication Function Classification System (CFCS), and no severe intellectual disability
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Cerebral Palsy
- Being tested
- Non-Interventional
- Keywords
- cerebral palsy, Strength and Difficulties Questionnaire, validity, reliability
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
This study has a observational design
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mental health on the 3-point Strength and Difficulties Questionnaire (SDQ) at 2 week
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).
Measured: Baseline and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jan 2024
- Primary completion15 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bingol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Bingöl, Bingol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527508
- Sponsor's protocol ID
- E-33117789-044-167349
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28914445Anthoine 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.
PubMed 25492701Bingol H, Karaoba DD. Reliability and Construct Validity of the Self-Report Version of Strengths and Difficulties Questionnaire in Children and Adolescents With Cerebral Palsy. Child Care Health Dev. 2025 Jul;51(4):e70114. doi: 10.1111/cch.70114.
PubMed 40490683
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct Validity and Intra-Observer Reliability of the Self-Report Version of Strengths and Difficulties Questionnaire in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06527508
- Acronym / sponsor ID
- E-33117789-044-167349
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, Strength and Difficulties Questionnaire, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bingol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- A diagnosis of CP, a communication level of I-III on the Communication Function Classification System (CFCS), and no severe intellectual disability
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalThis study has a observational design | Other | – |
Primary outcome
Change from baseline in mental health on the 3-point Strength and Difficulties Questionnaire (SDQ) at 2 week
Time frame: Baseline and Week 2
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 28914445Downs 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.
- Results publication: PubMed 25492701Anthoine 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.
- Derived from this study: PubMed 40490683Bingol H, Karaoba DD. Reliability and Construct Validity of the Self-Report Version of Strengths and Difficulties Questionnaire in Children and Adolescents With Cerebral Palsy. Child Care Health Dev. 2025 Jul;51(4):e70114. doi: 10.1111/cch.70114.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
Active, not recruitingObservational study
Feasibility of Vision-Language Models for Detecting Physical Assistance as an Observable Criterion Defining GMFCS Levels in Children Aged 2 to 6 Years With Cerebral Palsy
Cerebral Palsy
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Bingol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mental health on the 3-point Strength and Difficulties Questionnaire (SDQ) at 2 week (time frame: Baseline and Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527508, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.