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Parenting Program for Young Children With Spina Bifida

29 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85016
        • Phoenix Children's
        • Investigatore principale:
          • Adrien Winning, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
System Usability Scale
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hospital Depression and Anxiety Scale (HADS)
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Behavior Rating Inventory of Executive Function (BRIEF-P or -2)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Adrien Winning, Phoenix Children's Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2028

Completamento primario (Stimato)

1 gennaio 2029

Completamento dello studio (Stimato)

1 aprile 2029

Date di iscrizione allo studio

Primo inviato

19 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 ottobre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 ottobre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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