NCT06527508

Brief 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). 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 25, 2024

Last Update Submit

July 25, 2024

Conditions

Keywords

cerebral palsyStrength and Difficulties Questionnairevalidityreliability

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline and Week 2

Interventions

This study has a observational design

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • A diagnosis of CP, a communication level of I-III on the Communication Function Classification System (CFCS), and no severe intellectual disability

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bingöl University

Bingöl, 12000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28914445BACKGROUND
  • 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.

  • Bingol 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.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 30, 2024

Study Start

January 1, 2024

Primary Completion

May 15, 2024

Study Completion

June 15, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations