Increased Risk of ADHD Among Children With Bilateral Congenital Cataracts

NCT03692728 | Completed DMC

• 1 other identifier: CCPMOH2018- China9
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators conducted a cross-sectional, face-to-face investigation to evaluate the behavioral and psychological disorders and the risk of ADHD among children with bilateral congenital cataracts using the Conners'Parent Rating Scale (CPRS) questionnaire, an assessment tool for screening ADHD that obtains parental reports of childhood behavioral problems in research and clinical settings.15-17 Age-matched children with normal vision and the Chinese urban norm were used as controls.

Conditions

Childhood Cataract

Keywords

congenital cataract; attention deficit hyperactivity disorder; Conners'Parent Rating Scale-48

Outcome Measures

Primary Outcomes (1)

• Risk of ADHD

  The Conners' Parent Rating Scale 48 (CPRS-48) contains 5 evaluating subscales, including the conduct problems, learning problems, psychosomatic, impulsiveness/hyperactivity, and anxiety subscales. A total of 48 items are included in the questionnaire, and each item is scored from 0 to 3 (0 represents the best, 3 represents the worst). The final scores of the 5 subscales are defined as the mean scores of the corresponding items: conduct problems (2+8+14+19+20+21+22+23+27+33+34+39)/12; learning problems (10+25+31+37)/4; psychosomatic (32+41+43+44+48)/5; impulsiveness/hyperactivity (4+5+11+13)/4; anxiety (12+16+24+47)/4; and the hyperactivity index (4+7+11+13+14+25+31+33+37+38)/10. Final scores and the five subscales of the CPRS-48 between two groups were compared.

  2016.7-12

Study Arms (2)

CC children

CC children were registered members of the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH). All of them were diagnosed with CC by two experienced pediatric ophthalmologists based on a comprehensive evaluation of the onset age (within one year after birth), morphological features of lens opacity, family history, and detailed medical records.

Other: Psychological and Behavioral Problems

NV children

NV children were recruited from the Optometry Department of the ZOC as the control group. NV was defined as BCVA ≥0.3 (log MAR) in children between 3-5 years old or BCVA ≥0.15 (log MAR) in children older than 5 years. Children with strabismus and high refractive error (myopia or hyperopia: \>6.0 Diopters; astigmatism: \>3.0 Diopters) were excluded from NV group.

Other: Psychological and Behavioral Problems

Interventions

Psychological and Behavioral Problems OTHER

Differences in age and sex between the CC and NV groups were compared using the independent samples t test and Chi-square test, respectively. Comparisons of abnormal rates between the CC and NV groups were performed using the Chi-square test. Scores on all subscales recorded for the CC group were compared with those of the NV group and the Chinese urban norm using the independent samples t test and one-sample t test, respectively.

CC children; NV children

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

hospital-based

You may qualify if:

• CC children and NV children aged 3-8 years presenting to the Zhognshan Ophthalmic Center between July and December 2016.

You may not qualify if:

• Patients complicated with systemic manifestations, such as Lowe syndrome, Marfan syndrome, and Down syndrome, were excluded.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 2, 2018
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 4, 2018

Record last verified: 2018-09

Locations

CN (1)