Psychosocial Adjustment of Adolescents With Spina Bifida

NCT00891891 | Active Not Recruiting

• 1 other identifier: R01NR016235
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Spina Bifida

Keywords

spina bifida; psychosocial adjustment; adolescence; emerging adulthood

Outcome Measures

Primary Outcomes (3)

• Transition to Adult Healthcare Interview and Coding System

  Young adults will be asked questions about their pediatric care and whether they have transitioned to a primary care provider and/or an adult-oriented health care service. A quantitative coding system was developed by this team to score each participant on their transition status. The success of the transition is assessed separately for each provider, is based on an assessment of whether or not the youth has experienced transition-related meetings and includes an assessment of each youth's subjective opinion regarding their transition status. Finally, the success of the transition is assessed by examining how they manage health-related complications.

  when youth are 18 years old; 8-10 years after the start of the study

• Medical History Questionnaire

  Data regarding adherence will be obtained from the Medical History Questionnaire. The Medical History Questionnaire was adapted from the Parent-Report of Medical Adherence in Spina Bifida Scale (PROMASB, Holmbeck et al., 1998), which was developed for a previous study on youth with spina bifida by the same investigator. The measure is designed to obtain disease-specific medical information, including bowel and bladder functioning, ambulation, medications, providers and frequency of medical care, and surgery history.

  when youth are 18 years old; 8-10 years after the start of the study

• Spina Bifida Self-Management Profile

  The Spina Bifida Self-Management Profile (SBSMP) was developed by Wysocki and Gavin (2006). The SBSMP is a 14-question, structured interview addressing seven dimensions of the spina bifida regimen, including appointment keeping, bowel control program, skin and wound care, exercise, medications, clean intermittent catheterization, and dealing with urinary tract infections. Item content, wording, and scoring was developed with the consultation of medical experts. Internal consistency is acceptable, with an alpha of .66 for mothers of children with spina bifida (Wysocki \& Gavin, 2006). In this study, the SBSMP will be administered as a questionnaire rather than in interview format.

  when youth are 18 years old; 8-10 years after the start of the study

Secondary Outcomes (5)

• Sharing of Spina Bifida Management Responsibilities

  when youth are 18 years old; 8-10 years after the start of the study

• Spina Bifida Readiness for Self-Management

  when youth are 18 years old; 8-10 years after the start of the study

• Spina Bifida Independence Survey

  when youth are 18 years old; 8-10 years after the start of the study

• Spina Bifida Barriers to Adherence Questionnaire (SBBAQ)

  when youth are 18 years old; 8-10 years after the start of the study

• Spina Bifida Self-Efficacy Survey

  when youth are 18 years old; 8-10 years after the start of the study

Study Arms (1)

Spina Bifida

140 children with spina bifida (ages 8-15)

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with spina bifida (ages 8-15) and their families and close friends

You may qualify if:

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

Sponsors & Collaborators

• Loyola University Chicago: lead
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

Loyola University Chicago

Chicago, Illinois, 60626, United States

Location

Related Links

• Lab's website
• Holmbeck's professional website

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Grayson N Holmbeck, PhD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: September 1, 2005
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

US (1)