Clinical Trials Logo

Clinical Trial Summary

The purpose of this longitudinal study is to evaluate a developmentally-oriented bio-neuropsychological model of adjustment in youth and young adults with spina bifida. The theoretical framework for the study is a developmentally-oriented bio-neuropsychosocial model of psychological adjustment.


Clinical Trial Description

The purpose of this longitudinal study is to evaluate a developmentally-oriented bio-neuropsychological model of adjustment in youth and young adults with spina bifida (SB). The theoretical framework for the study is a developmentally-oriented bio-neuropsychosocial model of psychological adjustment. Extensive multi-source (i.e., youth, peers, parents, teachers, health professionals, and medical chart) and multi-method (i.e., questionnaires, interviews, neuropsychological testing, and observational) data are collected across several predictor variable domains: (1) biological (i.e., severity of disability, current and past health status, pubertal development), (2) neuropsychological (i.e., executive functions and attention, language pragmatics and inference making skills, emotion recognition), and (3) social (i.e., observed and perceived social behaviors with peers and family). A multidimensional perspective on adjustment will is adopted insofar as the following constructs are assessed: internalizing symptoms (e.g., depression), externalizing symptoms (e.g., aggression), social adjustment, romantic relationship involvement, quality of life and functional status, school performance, vocational achievements, autonomy development, independent living, medical adherence, and the transition to adult medical care. Within the context of this model, several mediation and moderation models are being tested to identify underlying mechanisms for associations between variables and to determine whether variables within one domain can compensate for deficits in another domain. This longitudinal study of youth with SB includes the following innovations: (1) videotaped social interactions between youth with SB and their close friends, (2) a comprehensive assessment of socially-relevant neuropsychological factors, (3) an extensive multi-respondent questionnaire- and interview-based evaluation of the targets' social adjustment, (4) an interview-based evaluation of the transition to emerging adulthood, and (5) an oversampling of Hispanic families. Currently, the investigators are collecting Times 4, 5 and 6 longitudinal data on a cohort of 140 youth with SB (ages 8-15 at Time 1, ages 10-17 at Time 2, ages 12-19 at Time 3, ages 14-21 at Time 4, ages 16-23 at Time 5, ages 18-25 at Time 6). Parents and a close friend participate when youth participants are under 18 years of age; when participants are 18 years and older, they are the sole participator. Data is collected via trained research assistants during home visits. Because of our efforts to select variables that are modifiable, findings of this study will inform interventions designed to address the social difficulties of youth with SB, interventions that facilitate young adults' full participation in the milestones of young adulthood, and the manuals of care that will be developed by the investigators. Moreover, findings will provide policy-relevant information to improve the transition to adult medical care for individuals with this debilitating birth defect. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00891891
Study type Observational
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact
Status Active, not recruiting
Phase
Start date September 2005
Completion date August 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Completed NCT02854150 - Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing
Completed NCT00655681 - Prevention of Post Operative Bone Loss in Children N/A
Completed NCT00378664 - Lumbar to Sacral Ventral Nerve Re-Routing Phase 2
Active, not recruiting NCT00031122 - Study of Genetic Risk Factors for Spina Bifida and Anencephaly N/A
Completed NCT03573726 - Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life N/A
Completed NCT03851107 - The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities N/A
Not yet recruiting NCT03698721 - Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
Recruiting NCT02938130 - The Impact of Community-based Wellness Programs on The Triple Aim N/A
Recruiting NCT02592291 - Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions N/A
Not yet recruiting NCT05784285 - Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities N/A
Completed NCT00720161 - Metformin in Children With Motor Deficit N/A
Completed NCT05858840 - Urinary Artificial Sphincter in Children
Completed NCT05861024 - Urinary Calculi After Bladder Augmentation in Children
Recruiting NCT04362592 - In-Utero Endoscopic Correction of Spina Bifida N/A
Recruiting NCT03856034 - Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele N/A
Enrolling by invitation NCT04186130 - Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study
Active, not recruiting NCT05117827 - Pediatric Powered Wheelchair Standing Devices: An Exploratory Study N/A
Completed NCT03121651 - Medication Management Among Individuals With Neurodevelopmental Disabilities N/A