Trial record 3 of 3 for:    neural tube defects | NICHD | NIH

Psychosocial Adjustment of Adolescents With Spina Bifida (CHATS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2009 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
March of Dimes
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00891891
First received: April 30, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

The purpose of this longitudinal study is to evaluate a developmentally-oriented bio-neuropsychosocial model of psychological adjustment in young adolescents with spina bifida (10-13 years old at Time 1 and 12-15 years old at Time 2). Extensive multi-source and multi-method data will be collected across several predictor variable domains: (1) biological, (2) neuropsychological, and (3) social. A multidimensional perspective on adolescent adjustment will also be adopted, with a rigorous focus on the adolescents' social adjustment. The proposed study will be the first to collect observed peer interaction data (target child with close friend) in adolescents with spina bifida. The degree to which neuropsychological limitations experienced by children with spina bifida contribute to their social difficulties and other psychological problems will also be examined. Participants will include a sample of 140 children and young adolescents with spina bifida (with meningomyelocele and shunted hydrocephalus) along with their parents, a close friend, teachers, and health professionals. Spanish-speaking Hispanic/Latino families will also be recruited. Questionnaire, interview, neuropsychological testing, and observational methods will be employed during two home visits at Time 1 and two home visits at Time 2. In addition to evaluating the utility of the bio-neuropsychosocial model, several mediational and moderational models will also be tested within the context of the more general model. Such models will facilitate identification of underlying mechanisms for associations between variables (i.e., mediational models) and will attempt to isolate variables within one domain that compensate for deficits in another domain (i.e., moderational models). Findings of this study will provide information on the differential relevance of family relationships, peer relationships, neuropsychological factors, and biological factors for adjustment in adolescents with spina bifida. Moreover, the results will have implications for prevention and intervention efforts with families who have offspring with disabling birth defects.


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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Social functioning/peer relationships [ Time Frame: longitudinal during adolescent development ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychosocial adjustment [ Time Frame: longitudinal during adolescent development ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2005
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spina Bifida
140 children with spina bifida (ages 8-15)

Detailed Description:

This study represents the critical next step in our developmentally-oriented program of research on the psychosocial adjustment of adolescents with spina bifida. Previously, we conducted a 10-year longitudinal study of family relationships and adjustment in such children and found that early family relationship variables were highly salient in the prediction of subsequent trajectories of adjustment. Moreover, adolescents with spina bifida were found to exhibit psychosocial adjustment difficulties, including significant social problems (i.e., social immaturity and passivity, less social contact with friends). This prior study was a between-groups investigation where children with spina bifida were compared with able-bodied comparison children and was the first of its kind to include an assessment of observed family interaction in children with spina bifida.

To understand better the underlying mechanisms that account for these significant psychosocial difficulties, funding is sought for a new within-group longitudinal study of children with spina bifida as they traverse the early adolescent stage of development. Unlike our previous study, this investigation will include a thorough assessment of children's peer relationships and neuropsychological factors as potential predictors of variability in psychosocial adjustment outcomes. The proposed study will be the first to collect observed peer interaction data (target child with close friend) in adolescents with spina bifida. Moreover, we will examine the degree to which neuropsychological limitations experienced by children with spina bifida may contribute to their social difficulties.

Thus, a developmentally-oriented bio-neuropsychosocial model of psychological adjustment will be evaluated in young adolescents with spina bifida (see Figure 1). Extensive multi-source and multi-method data will be 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 adolescent adjustment will also be adopted insofar as the following constructs will be assessed: internalizing symptoms (e.g., depression), externalizing symptoms (e.g., aggression), social adjustment, quality of life and functional status, school performance, autonomy development, and medical adherence (see Figure 1).

Participants will include a sample of 140 children and young adolescents with spina bifida (with meningomyelocele [MM] and shunted hydrocephalus; 10-13 years old at Time 1 and 12-15 years old at Time 2), along with their parents and a close friend. Spanish-speaking Hispanic/Latino families will also be recruited (given the high relative prevalence of spina bifida in this population), constituting approximately 20% of the sample. Teacher- and health professional-reported data and medical chart information will also be collected. Questionnaire, interview, neuropsychological testing, and observational methods will be employed during two home visits at Time 1 and two home visits at Time 2. Videotapes of family and peer interactions will be coded by trained graduate and undergraduate students.

In addition to testing the utility of the bio-neuropsychosocial model, several mediational and moderational models will also be tested (see Figures 2 and 3) within the context of the more general model in Figure 1. Such models will facilitate identification of underlying mechanisms for associations between variables (i.e., mediational models) and will attempt to isolate variables within one domain that compensate for deficits in another domain (i.e., moderational models). Findings of this study will provide information on the differential relevance of family relationships, peer relationships, neuropsychological factors, and biological factors for adjustment in adolescents with spina bifida. Moreover, the results will have implications for prevention and intervention efforts with families who have offspring with disabling birth defects (Dryfoos, 1990).

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
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:(1) young adolescents with spina bifida meningomyelocele (MM) and shunted hydrocephalus, given that they are more likely than children with milder forms of spina bifida (e.g., meningocele, lipomeningocele) to exhibit the neuropsychological difficulties that have been documented in past research (Fletcher et al., in press); moreover, spina bifida MM is the most common form of spina bifida with roughly 80-90% of such children having hydrocephalus, (2) ages 10-13 at Time 1, (3) families must reside within 100 miles of Chicago at Time 1, (4) absence of other comorbid chronic medical conditions, (5) IQ > 70, as assessed with the Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999), and (6) ability to speak and read English or Spanish.

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Exclusion Criteria:

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  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

Contacts
Contact: Grayson N Holmbeck, PhD 773-508-2967 gholmbe@luc.edu

Locations
United States, Illinois
Loyola University Chicago Recruiting
Chicago, Illinois, United States, 60626
Contact: Grayson N Holmbeck, PhD    773-508-2967    gholmbe@luc.edu   
Sponsors and Collaborators
March of Dimes
Investigators
Principal Investigator: Grayson N Holmbeck, PhD Loyola University Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Grayson N. Holmbeck, PhD, Loyola University Chicago
ClinicalTrials.gov Identifier: NCT00891891     History of Changes
Other Study ID Numbers: NICHD R01 HD048629, NICHD R01 HD048629
Study First Received: April 30, 2009
Last Updated: April 30, 2009
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Spina Bifida, psychosocial adjustment, adolescence

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

ClinicalTrials.gov processed this record on August 26, 2014