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Parenting Program for Young Children With Spina Bifida

29 oktober 2026 bijgewerkt door: Phoenix Children's Hospital

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:

  1. Are caregivers of young children with spina bifida willing to participate in the program and complete assessments before and after the program?
  2. Do caregivers rate the program as easy to use and helpful?
  3. How can the program be improved in the future?
  4. 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85016
        • Phoenix Children's
        • Hoofdonderzoeker:
          • Adrien Winning, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria for the Caregiver:

  • 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

Inclusion Criteria for the Child with Spina Bifida:

  • 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

Exclusion Criteria:

  • Not applicable

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Positive Parenting Program

This digital health intervention involves completing 6 online modules focusing on caregiver stress management and positive parenting skills.

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
System Usability Scale
Tijdsspanne: 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).

3 months post-enrollment
Adapted Website Evaluation Questionnaire (WEQ)
Tijdsspanne: 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.

3 months post-enrollment
Enrollment rate
Tijdsspanne: 3 and 6 month post-enrollment

Enrollment rate (#enrolled/#approached; milestone greater than or equal to 50%) will indicate feasibility of the program.

3 and 6 month post-enrollment
Completion rate
Tijdsspanne: 3 and 6 month post-enrollment

Completion rate (# completing sessions/#enrolled; milestone greater than or equal to 75%) will indicate feasibility of the program.

3 and 6 month post-enrollment
Retention rate
Tijdsspanne: 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.

3 and 6 month post-enrollment
Feasibility Intervention Measure (FIM)
Tijdsspanne: 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.

3 and 6 month post-enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hospital Depression and Anxiety Scale (HADS)
Tijdsspanne: 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).

Baseline, 3 and 6 months post-enrollment
Play and Alternative Learning Strategies parent-child interaction coding
Tijdsspanne: 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.

Baseline, 3 and 6 month follow up

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Behavior Rating Inventory of Executive Function (BRIEF-P or -2)
Tijdsspanne: 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).

Baseline, 3 and 6 months post-enrollment
Conners Early Childhood
Tijdsspanne: 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).

Baseline, 3 and 6 months post-enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Adrien Winning, Phoenix Children's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2028

Primaire voltooiing (Geschat)

1 januari 2029

Studie voltooiing (Geschat)

1 april 2029

Studieregistratiedata

Eerst ingediend

19 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 oktober 2026

Eerst geplaatst (Werkelijk)

4 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

29 oktober 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

All collected, deidentified quantitative IPD for the primary and secondary outcomes of the study for participants who consent to have their data shared.

IPD-tijdsbestek voor delen

IPD will be made available after the primary outcomes manuscript is published and will be available for at least seven years post study closure.

IPD-toegangscriteria voor delen

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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