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Parenting Program for Young Children With Spina Bifida

2026年10月29日 更新者: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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Arizona
      • Phoenix、Arizona、アメリカ、85016
        • Phoenix Children's
        • 主任研究者:
          • Adrien Winning, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
System Usability Scale
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Hospital Depression and Anxiety Scale (HADS)
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Behavior Rating Inventory of Executive Function (BRIEF-P or -2)
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Adrien Winning、Phoenix Children's Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2028年1月1日

一次修了 (推定)

2029年1月1日

研究の完了 (推定)

2029年4月1日

試験登録日

最初に提出

2026年10月19日

QC基準を満たした最初の提出物

2026年10月29日

最初の投稿 (実際)

2026年11月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年10月29日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

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 共有アクセス基準

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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