Spina BifidaNCT07915557
Parenting Program for Young Children With Spina Bifida
A study testing Positive Parenting Program in people with Spina Bifida, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to test and improve an online program for caregivers of young children with spina bifida. Investigators hope to learn whether the program can improve caregiver stress and positive parenting behaviors during early childhood. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Positive Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2028to Apr 2029
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Caregiver is the parent or legal guardian of the child
- Caregiver lives with the child at least 50% of the time
- Caregiver is fluent in English
- Child has Spina Bifida (e.g., myelomeningocele, meningocele, lipomyelomeningocele)
- Child is between the ages of 2.5 and 6 years old, but no older than 6.5 years old at study enrollment
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Phoenix Children's
Phoenix, Arizona, 85016
Adrien Winning, PhD
About this study
Official title: Addressing Health Disparities in Underserved Families of Young Children With Spina Bifida Through a Community-Informed Intervention
The goal of this clinical trial is to test and improve an online program for caregivers of young children with spina bifida. Investigators hope to learn whether the program can improve caregiver stress and positive parenting behaviors during early childhood. In the preliminary phase of this clinical trial, investigators are aiming to answer these questions:
- Are caregivers of young children with spina bifida willing to participate in the program and complete assessments before and after the program?
- Do caregivers rate the program as easy to use and helpful?
- How can the program be improved in the future?
- Does the program result in clinically meaningful reductions in caregivers' stress and increase caregivers' use of positive parenting strategies?
Read more
Caregivers of young children with spina bifida who agree to participate will complete surveys when they begin the study and a videotaped interaction task playing with their child. Children will complete a brief developmental test.
Caregivers will then complete the program, involving completing 6 weekly online modules that are paired with a 1-hour group meeting with other caregivers. Sessions will focus on helping caregivers connect with others who have a young child with spina bifida, as well as helping families cope with stress and support early child development.
Caregivers will repeat the surveys and videotaped interaction task again three months later, after the program is completed, and again six months later. They will also be invited to participate in an interview to learn about their experience in the program.
Read the detailed description
This study will involve rapid-cycle testing of the program with 10 caregivers of young children with spina bifida to examine usability, feasibility, acceptability, and proof-of-concept (i.e., clinically meaningful change for individual families) to refine the intervention and implementation plan. Rapid-cycle testing will determine the program's optimal duration and format. This will be completed in partnership with advisory boards comprised of 10 caregivers of children with spina bifida and 10 healthcare providers ("co-designers"), with an emphasis on families from low-income and rural backgrounds who can experience barriers to care. The proposed study is an important first step towards developing an evidence-based treatment that can be used to support families of young children with spina bifida.
- Conditions
- Spina Bifida
- Being tested
- Positive Parenting Program
- Keywords
- Spina Bifida, Parenting, Child Development, Caregiver Stress
- Medical subject headings
- Spinal Dysraphism, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Parenting ProgramBehavioural
The digital health intervention is based on the Parent Acceptance and Commitment Therapy (PACT) and positive parenting literature. Caregivers in the program will complete 6 self-directed online modules that are paired with group sessions, where caregivers can meet others who have a child with spina bifida and discuss how to use what they learned in the modules in daily life.
| Study group | Role | What they receive |
|---|---|---|
| Positive Parenting Program | Experimental | This digital health intervention involves completing 6 online modules focusing on caregiver stress management and positive parenting skills. Receives: Behavioral: Positive Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
This is a 10-item measure that will quantitatively assess usability of our online program. The SUS measures how accessible the website is and whether participants can understand the content of the website on a scale of 0-100. We will continue to recruit until our website has achieved an average score of >68% (above average).
Measured: 3 months post-enrollment
Adapted Website Evaluation Questionnaire (WEQ)
This measure will assess accessibility and satisfaction with the Program. Four overall items will be rated from 1-10 by participants. The overall score will be the average response across items. A higher score indicates higher satisfaction with the program. Overall scores of 8 or higher (> 80%) are an indication of satisfaction with the program.
Measured: 3 months post-enrollment
Enrollment rate
Enrollment rate (#enrolled/#approached; milestone greater than or equal to 50%) will indicate feasibility of the program.
Measured: 3 and 6 month post-enrollment
Completion rate
Completion rate (# completing sessions/#enrolled; milestone greater than or equal to 75%) will indicate feasibility of the program.
Measured: 3 and 6 month post-enrollment
Retention rate
Retention rate (#completers of 3 and 6 month assessments/ # enrolled at baseline; milestone greater than or equal to 70%) will indicate feasibility of the program.
Measured: 3 and 6 month post-enrollment
Feasibility Intervention Measure (FIM)
The four-item FIM (milestone greater than or equal to 80%) will be used to indicate feasibility of the program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the program as more feasible, an overall score of 4 or higher (80%) means a participant found the program to be feasible.
Measured: 3 and 6 month post-enrollment
Secondary outcomes (2)
Hospital Depression and Anxiety Scale (HADS)
Caregivers will complete the Hospital Anxiety and Depression Scale (HADS) which yields Anxiety and Depression Total Scores. The HADS Anxiety/Depression subscales each include 7 items and total scores can range from 0-21, with higher scores reflecting greater symptomatology. Proof-of-concept will be determined if at least 6 caregivers report maintenance of non-clinical levels of anxiety/depression or demonstrate clinically meaningful reductions in caregiver distress (i.e., movement from clinical [≥8] to non-clinical range [<8] on HADS anxiety/depression scale).
Measured: Baseline, 3 and 6 months post-enrollment
Play and Alternative Learning Strategies parent-child interaction coding
Caregivers will videorecord themselves engaging in at least 10 minutes of play with their child. Positive parenting behaviors will be rated with the standardized Play and Learning Strategies (PALS) coding scheme by blinded, trained raters. The coding scheme includes overall ratings of responsiveness and warmth (4-point scale), as well as frequency counts of scaffolding, praise, and verbal directives. Proof-of-concept will be determined if at least 6 caregivers demonstrate improvements by greater than 1 point on observed positive parenting behaviors from baseline.
Measured: Baseline, 3 and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startJan 2028 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionApr 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a small pilot where all 10 caregivers will receive the digital health intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Adrien Winning, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915557
- Sponsor's protocol ID
- 26-036
- Other IDs
- 1K23MD020447-01A1
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected, deidentified quantitative IPD for the primary and secondary outcomes of the study for participants who consent to have their data shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Health Disparities in Underserved Families of Young Children With Spina Bifida Through a Community-Informed Intervention
- ClinicalTrials.gov ID
- NCT07915557
- Acronym / sponsor ID
- 26-036
- Conditions
- Spina Bifida
- Keywords
- Spina Bifida, Parenting, Child Development, Caregiver Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jan 2028 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 4 Nov 2026 (actual)
- 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 goal of this clinical trial is to test and improve an online program for caregivers of young children with spina bifida. Investigators hope to learn whether the program can improve caregiver stress and positive parenting behaviors during early childhood. In the preliminary phase of this clinical trial, investigators are aiming to answer these questions:
- Are caregivers of young children with spina bifida willing to participate in the program and complete assessments before and after the program?
- Do caregivers rate the program as easy to use and helpful?
- How can the program be improved in the future?
- Does the program result in clinically meaningful reductions in caregivers' stress and increase caregivers' use of positive parenting strategies?
Caregivers of young children with spina bifida who agree to participate will complete surveys when they begin the study and a videotaped interaction task playing with their child. Children will complete a brief developmental test.
Caregivers will then complete the program, involving completing 6 weekly online modules that are paired with a 1-hour group meeting with other caregivers. Sessions will focus on helping caregivers connect with others who have a young child with spina bifida, as well as helping families cope with stress and support early child development.
Caregivers will repeat the surveys and videotaped interaction task again three months later, after the program is completed, and again six months later. They will also be invited to participate in an interview to learn about their experience in the program.
Detailed description
This study will involve rapid-cycle testing of the program with 10 caregivers of young children with spina bifida to examine usability, feasibility, acceptability, and proof-of-concept (i.e., clinically meaningful change for individual families) to refine the intervention and implementation plan. Rapid-cycle testing will determine the program's optimal duration and format. This will be completed in partnership with advisory boards comprised of 10 caregivers of children with spina bifida and 10 healthcare providers ("co-designers"), with an emphasis on families from low-income and rural backgrounds who can experience barriers to care. The proposed study is an important first step towards developing an evidence-based treatment that can be used to support families of young children with spina bifida.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a small pilot where all 10 caregivers will receive the digital health intervention.
| Arm | Type | Receives |
|---|---|---|
| Positive Parenting Program | Experimental | Behavioral: Positive Parenting ProgramThis digital health intervention involves completing 6 online modules focusing on caregiver stress management and positive parenting skills. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Caregiver is the parent or legal guardian of the child
- Caregiver lives with the child at least 50% of the time
- Caregiver is fluent in English
- Child has Spina Bifida (e.g., myelomeningocele, meningocele, lipomyelomeningocele)
- Child is between the ages of 2.5 and 6 years old, but no older than 6.5 years old at study enrollment
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Parenting ProgramThe digital health intervention is based on the Parent Acceptance and Commitment Therapy (PACT) and positive parenting literature. Caregivers in the program will complete 6 self-directed online modules that are paired with group sessions, where caregivers can meet others who have a child with spina bifida and discuss how to use what they learned in the modules in daily life. | Behavioural | Positive Parenting Program |
Primary outcome
System Usability Scale
Time frame: 3 months post-enrollment
This is a 10-item measure that will quantitatively assess usability of our online program. The SUS measures how accessible the website is and whether participants can understand the content of the website on a scale of 0-100. We will continue to recruit until our website has achieved an average score of >68% (above average).
Adapted Website Evaluation Questionnaire (WEQ)
Time frame: 3 months post-enrollment
This measure will assess accessibility and satisfaction with the Program. Four overall items will be rated from 1-10 by participants. The overall score will be the average response across items. A higher score indicates higher satisfaction with the program. Overall scores of 8 or higher (> 80%) are an indication of satisfaction with the program.
Enrollment rate
Time frame: 3 and 6 month post-enrollment
Enrollment rate (#enrolled/#approached; milestone greater than or equal to 50%) will indicate feasibility of the program.
Completion rate
Time frame: 3 and 6 month post-enrollment
Completion rate (# completing sessions/#enrolled; milestone greater than or equal to 75%) will indicate feasibility of the program.
Retention rate
Time frame: 3 and 6 month post-enrollment
Retention rate (#completers of 3 and 6 month assessments/ # enrolled at baseline; milestone greater than or equal to 70%) will indicate feasibility of the program.
Feasibility Intervention Measure (FIM)
Time frame: 3 and 6 month post-enrollment
The four-item FIM (milestone greater than or equal to 80%) will be used to indicate feasibility of the program. Each item is rated from 1-5 and the final score for the measure is the average number for all answers. A higher score means a participant rated the program as more feasible, an overall score of 4 or higher (80%) means a participant found the program to be feasible.
2 secondary outcomes
Hospital Depression and Anxiety Scale (HADS)
Time frame: Baseline, 3 and 6 months post-enrollment
Play and Alternative Learning Strategies parent-child interaction coding
Time frame: Baseline, 3 and 6 month follow up
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 4 Nov 2026.
- Individual participant dataSharing planned: Yes. All collected, deidentified quantitative IPD for the primary and secondary outcomes of the study for participants who consent to have their data shared.
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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.
Adrien Winning principal investigator
Phoenix Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Parenting Program in people with Spina Bifida, run by Phoenix Children's Hospital 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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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?
Contact Adrien Winning, PhD (602-933-4589, awinning@phoenixchildrens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: 3 months post-enrollment). The study lists 6 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 4 Nov 2026.