An interventional study of Positive Parenting Program in Spina Bifida, sponsored by Phoenix Children's Hospital. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Phoenix Children's Hospital · Not applicable, Interventional, and Supportive care
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:
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.
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.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →Phoenix Children's Hospital is the lead sponsor of 42 studies on the registry; 8 are open to participants now.
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Inclusion Criteria for the Child with Spina Bifida:
Exclusion Criteria:
This digital health intervention involves completing 6 online modules focusing on caregiver stress management and positive parenting skills.
Behavioral: Positive Parenting Program
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.
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).
Time frame: 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.
Time frame: 3 months post-enrollment
Enrollment rate
Enrollment rate (#enrolled/#approached; milestone greater than or equal to 50%) will indicate feasibility of the program.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 and 6 month post-enrollment
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).
Time frame: 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.
Time frame: Baseline, 3 and 6 month follow up
Behavior Rating Inventory of Executive Function (BRIEF-P or -2)
Caregivers will complete the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P; ages 2 to 5 years) or the BRIEF-2 (ages 5 years+), yielding a General Executive Composite. Proof-of-concept will be determined if 6 caregivers report either that the child has maintained non-clinical levels of executive functioning problems or has reduced executive functioning problems to the non-clinical range post-intervention (i.e., General Executive Composite T-score less than or equal to 65).
Time frame: Baseline, 3 and 6 months post-enrollment
Conners Early Childhood
Caregivers will also complete the Conners Early Childhood (Conners EC). Proof-of-concept will be determined if 6 caregivers report that the child has either maintained normative levels on relevant developmental scales (Social Functioning, Mood/Affect, Defiance/Temper scales) or improved to a normative range (i.e., \< T-score of 65).
Time frame: Baseline, 3 and 6 months post-enrollment
Plan to share: Yes — All collected, deidentified quantitative IPD for the primary and secondary outcomes of the study for participants who consent to have their data shared.
Time frame: IPD will be made available after the primary outcomes manuscript is published and will be available for at least seven years post study closure.
Access criteria: Interested parties will be able to access the IPD by contacting the PI or through request at the Inter-university Consortium for Political and Social Research.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Phoenix Children's Hospital