Spina BifidaCHATSNCT00891891
Psychosocial Adjustment of Adolescents With Spina Bifida
An observational study of Spina Bifida, run by Loyola University Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Spina Bifida
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to 1 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with spina bifida (ages 8-15) and their families and close friends
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spina Bifida
- Keywords
- spina bifida, psychosocial adjustment, adolescence, emerging adulthood
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spina Bifida | 140 children with spina bifida (ages 8-15) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: when youth are 18 years old; 8-10 years after the start of the study
Secondary outcomes (5)
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.
Measured: when youth are 18 years old; 8-10 years after the start of the study
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).
Measured: when youth are 18 years old; 8-10 years after the start of the study
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?")
Measured: when youth are 18 years old; 8-10 years after the start of the study
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).
Measured: when youth are 18 years old; 8-10 years after the start of the study
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).
Measured: when youth are 18 years old; 8-10 years after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startSep 2005
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Grayson N. Holmbeck, PhD, Loyola University Chicago
- Investigators
- Grayson N Holmbeck, PhD, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891891
- Sponsor's protocol ID
- R01NR016235
- Acronym
- CHATS
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2009
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Adjustment of Adolescents With Spina Bifida
- ClinicalTrials.gov ID
- NCT00891891
- Acronym / sponsor ID
- CHATS / R01NR016235
- Conditions
- Spina Bifida
- Keywords
- spina bifida, psychosocial adjustment, adolescence, emerging adulthood
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Loyola University ChicagoUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- Sep 2005
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spina Bifida | – | –140 children with spina bifida (ages 8-15) |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with spina bifida (ages 8-15) and their families and close friends
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transition to Adult Healthcare Interview and Coding System
Time frame: when youth are 18 years old; 8-10 years after the start of the study
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.
Medical History Questionnaire
Time frame: when youth are 18 years old; 8-10 years after the start of the study
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.
Spina Bifida Self-Management Profile
Time frame: when youth are 18 years old; 8-10 years after the start of the study
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.
5 secondary outcomes
Sharing of Spina Bifida Management Responsibilities
Time frame: when youth are 18 years old; 8-10 years after the start of the study
Spina Bifida Readiness for Self-Management
Time frame: when youth are 18 years old; 8-10 years after the start of the study
Spina Bifida Independence Survey
Time frame: when youth are 18 years old; 8-10 years after the start of the study
Spina Bifida Barriers to Adherence Questionnaire (SBBAQ)
Time frame: when youth are 18 years old; 8-10 years after the start of the study
Spina Bifida Self-Efficacy Survey
Time frame: when youth are 18 years old; 8-10 years after the start of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Lab's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grayson N Holmbeck, PhD principal investigator
Loyola University Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spina Bifida, run by Loyola University Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition to Adult Healthcare Interview and Coding System (time frame: when youth are 18 years old; 8-10 years after the start of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.