Parenting Program for Young Children With Spina Bifida

NCT07915557, Not applicable, Not yet recruiting, Phoenix Children's Hospital

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Parenting Program for Young Children With Spina Bifida	ClinicalTrials.gov
NCT number	NCT07915557	ClinicalTrials.gov
Status	Not yet recruiting	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	30 participants, estimated	ClinicalTrials.gov
Lead sponsor	Phoenix Children's Hospital	ClinicalTrials.gov
Conditions	Spina Bifida	ClinicalTrials.gov
Interventions	Positive Parenting Program	ClinicalTrials.gov
First posted	2026-11-04	ClinicalTrials.gov
Last updated	2026-11-04	ClinicalTrials.gov

Registered outcomes 10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	System Usability Scale	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).	ClinicalTrials.gov
Primary	Adapted Website Evaluation Questionnaire (WEQ)	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.	ClinicalTrials.gov
Primary	Enrollment rate	3 and 6 month post-enrollment	Enrollment rate (#enrolled/#approached; milestone greater than or equal to 50%) will indicate feasibility of the program.	ClinicalTrials.gov
Primary	Completion rate	3 and 6 month post-enrollment	Completion rate (# completing sessions/#enrolled; milestone greater than or equal to 75%) will indicate feasibility of the program.	ClinicalTrials.gov
Primary	Retention rate	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.	ClinicalTrials.gov
Primary	Feasibility Intervention Measure (FIM)	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.	ClinicalTrials.gov
Secondary	Hospital Depression and Anxiety Scale (HADS)	Baseline, 3 and 6 months post-enrollment	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).	ClinicalTrials.gov
Secondary	Play and Alternative Learning Strategies parent-child interaction coding	Baseline, 3 and 6 month follow up	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.	ClinicalTrials.gov
Other	Behavior Rating Inventory of Executive Function (BRIEF-P or -2)	Baseline, 3 and 6 months post-enrollment	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).	ClinicalTrials.gov
Other	Conners Early Childhood	Baseline, 3 and 6 months post-enrollment	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).	ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units	Source

Participant flow 0

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted	Source

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source

Adverse event totals 0

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
K23MD020447	Addressing Health Disparities in Underserved Families of Young Children with Spina Bifida Through a Community-Informed Intervention	Winning, Adrien Marie	PHOENIX CHILDREN'S HOSPITAL	NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES	2026	NIH RePORTER

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)