Psychosocial Adjustment of Adolescents With Spina Bifida (CHATS)
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| ClinicalTrials.gov Identifier: NCT00891891 |
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Recruitment Status
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Active, not recruiting
First Posted
: May 1, 2009
Last Update Posted
: April 18, 2017
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| Condition or disease |
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| Spina Bifida |
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 |
| Estimated Enrollment : | 140 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Psychosocial Adjustment of Adolescents With Spina Bifida |
| Study Start Date : | September 2005 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
| Group/Cohort |
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Spina Bifida
140 children with spina bifida (ages 8-15)
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- Social functioning/peer relationships [ Time Frame: at each data collection wave (Time 1 through Time 6) ]
- 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 ]
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| Ages Eligible for Study: | 8 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891891
| United States, Illinois | |
| Loyola University Chicago | |
| Chicago, Illinois, United States, 60626 | |
| Principal Investigator: | Grayson N Holmbeck, PhD | Loyola University Chicago |
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 |
| First Posted: | May 1, 2009 Key Record Dates |
| Last Update Posted: | April 18, 2017 |
| Last Verified: | April 2017 |
Keywords provided by Grayson Holmbeck, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
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spina bifida, psychosocial adjustment, adolescence, emerging adulthood |
Additional relevant MeSH terms:
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Spinal Dysraphism Neural Tube Defects Nervous System Malformations Nervous System Diseases Congenital Abnormalities |