Clinical trial NCT00891891: Psychosocial Adjustment of Adolescents With Spina Bifida
Official title: Psychosocial Adjustment of Adolescents With Spina Bifida
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spina Bifida
Keywords: spina bifida
psychosocial adjustment
adolescence
emerging adulthood
Lead sponsor: Loyola University Chicago
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2009-05-01
Enrollment: 140
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with spina bifida (ages 8-15) and their families and close friends

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.

Eligibility criteria: Inclusion criteria for youth with SB were:

1. a diagnosis of SB (types included myelomeningocele, lipomeningocele, myelocystocele),
2. age 8-15 years at Time 1,
3. ability to speak and read English or Spanish,
4. involvement of at least one primary custodial caregiver,
5. 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.

Primary outcomes:
measure: Transition to Adult Healthcare Interview and Coding System
timeFrame: when youth are 18 years old; 8-10 years after the start of the study
measure: Medical History Questionnaire
timeFrame: when youth are 18 years old; 8-10 years after the start of the study
measure: Spina Bifida Self-Management Profile
timeFrame: when youth are 18 years old; 8-10 years after the start of the study
Secondary outcomes:
measure: Sharing of Spina Bifida Management Responsibilities
timeFrame: when youth are 18 years old; 8-10 years after the start of the study
measure: Spina Bifida Readiness for Self-Management
timeFrame: when youth are 18 years old; 8-10 years after the start of the study
measure: Spina Bifida Independence Survey
timeFrame: when youth are 18 years old; 8-10 years after the start of the study
measure: Spina Bifida Barriers to Adherence Questionnaire (SBBAQ)
timeFrame: when youth are 18 years old; 8-10 years after the start of the study
measure: Spina Bifida Self-Efficacy Survey
timeFrame: when youth are 18 years old; 8-10 years after the start of the study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Loyola University Chicago
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Grayson N Holmbeck, PhD
role: PRINCIPAL_INVESTIGATOR
References: