Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00891891
Other study ID # R01NR016235
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2005
Est. completion date August 1, 2025

Study information

Verified date September 2022
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 8 Years to 15 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Loyola University Chicago Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) March of Dimes, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Sharing of Spina Bifida Management Responsibilities A self-report measure of psychosocial adjustment, the Sharing of Spina Bifida Management Responsibilities (SOSBMR) is adapted from the Diabetes Family Responsibility Questionnaire (DFRQ; Anderson, Auslander, Jung, Miller, & Santiago, 1990). The DFRQ consists of 17 items that describe diabetes and general health-related situations or tasks relevant to children and adolescents. Reporters rate each task on a three-point Likert scale as a child, parent, or shared responsibility. Participants were instructed to check the N/A box if the task is not part of their care. Higher scores indicate greater child responsibility. Items fall into three subscales, including general health maintenance, regimen tasks, and social presentation of diabetes. when youth are 18 years old; 8-10 years after the start of the study
Secondary Spina Bifida Readiness for Self-Management A self-report measure of psychosocial adjustment, the Spina Bifida Readiness for Self-Management questionnaire is a self-report questionnaire adapted from a model of stages of change relating to smoking cessation (DiClemente et al., 1991). The Spina Bifida Readiness for Self-Management questionnaire instructs respondents to indicate the frequency of behaviors over the prior six months across 14 items relating to appointment keeping, bowel control program, skin and wound care, exercise, medications, clean intermittent catheterization, and dealing with urinary tract infections. The questionnaire also assesses the presence and frequency of spina bifida-related complications (i.e., pressure sores/wounds on skin) over the previous six months, and co-occurring medical disorders (i.e., Type II diabetes). when youth are 18 years old; 8-10 years after the start of the study
Secondary Spina Bifida Independence Survey A self-report measure of psychosocial adjustment, the Spina Bifida Independence Survey (SBIS) is adapted from the Diabetes Independence Survey (DIS; Wysocki et al., 1996). The DIS is a brief measure of the parent's evaluation of the child's growth and development of diabetes knowledge and skills among children and adolescents with diabetes. Participants respond "yes" or "no" to whether their child has mastered a disease-related skill (e.g. "Can your child state each type of insulin he/she uses?") when youth are 18 years old; 8-10 years after the start of the study
Secondary Spina Bifida Barriers to Adherence Questionnaire (SBBAQ) A self-report measure of psychosocial adjustment, the Spina Bifida Barriers to Adherence Questionnaire (SBBAQ) is a self-report measure assessing multiple spina bifida-related barriers, adapted from the Barriers to Diabetes Adherence (BDA) measure for adolescents (Mulvaney, et al., 2011). The SBBAQ instructs subjects to indicate how true to them different statements are on a five-point likert scale (1 = Completely Not True to 5 = Completely True). when youth are 18 years old; 8-10 years after the start of the study
Secondary Spina Bifida Self-Efficacy Survey A self-report measure of psychosocial adjustment, the Spina Bifida Self-Efficacy Survey (SBSS) is a self-report questionnaire adapted from a measure of self-efficacy and self-management for adolescents with diabetes (Iannotti et al., 2006). The SBSS instructs respondents to indicate how sure they are they can complete tasks on their own all of the time across 17 items, on a five-point likert scale (i.e., 1 = Completely Unsure to 5 = Completely Sure). when youth are 18 years old; 8-10 years after the start of the study
See also
  Status Clinical Trial Phase
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Completed NCT02854150 - Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing
Completed NCT00655681 - Prevention of Post Operative Bone Loss in Children N/A
Completed NCT00378664 - Lumbar to Sacral Ventral Nerve Re-Routing Phase 2
Active, not recruiting NCT00031122 - Study of Genetic Risk Factors for Spina Bifida and Anencephaly N/A
Completed NCT03573726 - Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life N/A
Completed NCT03851107 - The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities N/A
Not yet recruiting NCT03698721 - Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
Recruiting NCT02938130 - The Impact of Community-based Wellness Programs on The Triple Aim N/A
Recruiting NCT02592291 - Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions N/A
Not yet recruiting NCT05784285 - Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities N/A
Completed NCT00720161 - Metformin in Children With Motor Deficit N/A
Completed NCT05861024 - Urinary Calculi After Bladder Augmentation in Children
Completed NCT05858840 - Urinary Artificial Sphincter in Children
Recruiting NCT03856034 - Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele N/A
Recruiting NCT04362592 - In-Utero Endoscopic Correction of Spina Bifida N/A
Enrolling by invitation NCT04186130 - Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study
Active, not recruiting NCT05117827 - Pediatric Powered Wheelchair Standing Devices: An Exploratory Study N/A
Completed NCT03121651 - Medication Management Among Individuals With Neurodevelopmental Disabilities N/A