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Trial record 1 of 3 for:    spina bifida and NICHD
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Psychosocial Adjustment of Adolescents With Spina Bifida (CHATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00891891
Recruitment Status : Active, not recruiting
First Posted : May 1, 2009
Last Update Posted : April 18, 2017
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)

Tracking Information
First Submitted Date April 30, 2009
First Posted Date May 1, 2009
Last Update Posted Date April 18, 2017
Study Start Date September 2005
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 14, 2017)
Social functioning/peer relationships [ Time Frame: at each data collection wave (Time 1 through Time 6) ]
Original Primary Outcome Measures
 (submitted: April 30, 2009)
Social functioning/peer relationships [ Time Frame: longitudinal during adolescent development ]
Change History
Current Secondary Outcome Measures
 (submitted: April 14, 2017)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: April 30, 2009)
Psychosocial adjustment [ Time Frame: longitudinal during adolescent development ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychosocial Adjustment of Adolescents With Spina Bifida
Official Title Psychosocial Adjustment of Adolescents With Spina Bifida
Brief 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with spina bifida (ages 8-15) and their families and close friends
Condition Spina Bifida
Intervention Not Provided
Study Groups/Cohorts Spina Bifida
140 children with spina bifida (ages 8-15)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 30, 2009)
140
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00891891
Other Study ID Numbers NICHD R01 HD048629
NICHD R01 HD048629
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Grayson Holmbeck, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
  • March of Dimes
  • National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Grayson N Holmbeck, PhD Loyola University Chicago
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date April 2017