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Trial record 1 of 71 for:    "Spina bifida"
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Psychosocial Adjustment of Adolescents With Spina Bifida (CHATS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
March of Dimes
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Grayson Holmbeck, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00891891
First received: April 30, 2009
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
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.

Condition
Spina Bifida

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychosocial Adjustment of Adolescents With Spina Bifida

Resource links provided by NLM:


Further study details as provided by Grayson Holmbeck, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Social functioning/peer relationships [ Time Frame: at each data collection wave (Time 1 through Time 6) ]

Secondary Outcome Measures:
  • Psychosocial adjustment [ Time Frame: at each data collection wave (Time 1 through Time 6) ]
  • Transition to adult healthcare [ Time Frame: Time 5 and Time 6 ]

Estimated Enrollment: 140
Study Start Date: September 2005
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spina Bifida
140 children with spina bifida (ages 8-15)

Detailed 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.

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with spina bifida (ages 8-15) and their families and close friends
Criteria
Inclusion criteria for youth with SB were: (a) a diagnosis of SB (types included myelomeningocele, lipomeningocele, myelocystocele), (b) age 8-15 years at Time 1, (c) ability to speak and read English or Spanish, (d) involvement of at least one primary custodial caregiver, and (e) residence within 300 miles of the laboratory (to allow for home visits to collect data). Latino families were intentionally oversampled to better study this subpopulation of youth with SB, given their prevalence.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891891

Locations
United States, Illinois
Loyola University Chicago
Chicago, Illinois, United States, 60626
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March of Dimes
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Grayson N Holmbeck, PhD Loyola University Chicago
  More Information

Additional Information:
Responsible Party: Grayson Holmbeck, Principal Investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00891891     History of Changes
Other Study ID Numbers: NICHD R01 HD048629
Study First Received: April 30, 2009
Last Updated: April 14, 2017

Keywords provided by Grayson Holmbeck, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
spina bifida, psychosocial adjustment, adolescence, emerging adulthood

Additional relevant MeSH terms:
Spinal Dysraphism
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 21, 2017