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Pilot Factorial Trial in Malaysia

2026年5月13日 更新者：DrJamieLachman、University of Oxford

A Pilot Cluster Randomised Trial of a Hybrid Human-digital Playful Parenting Programme to Improve Positive Parenting, Learning Through Play, and Child Educational Outcomes Among Preschool Children in Malaysia

This pilot study aims to determine the feasibility, acceptability, and engagement for different combinations of three components of a human-digital hybrid playful parenting programme, "Naungan Kasih (NK) Parenting Programme", in Malaysia. The first component is ParentText, a chatbot-led parenting programme, which will be delivered to all participants. The second component is in-person sessions facilitated by trained teachers, and the third component consists of remote online WhatsApp support groups. The research aims to investigate the differential feasibility, acceptability, and engagement for NK when ParentText is delivered with a) 1 or 2 in-person sessions, and b) with remote online WhatsApp support groups (Yes/No). The combinations of Parent Text (which will be delivered to all participants) with the in-person sessions and WhatsApp support groups yields four treatment conditions:

  1. ParentText + 1 in-person session
  2. ParentText + 1 in-person session + WhatsApp support
  3. ParentText + 2 in-person sessions
  4. ParentText + 2 in-person sessions + WhatsApp support

This pilot aims to examine the feasibility of the delivery of the different combinations of intervention components, and the user-engagement for each condition, in preparation for a full factorial trial in 2024. Data from this pilot will be used to inform modifications to the programme and study methods prior to the larger factorial trial. The pilot study also aims to provide preliminary exploratory data regarding the relative effectiveness of the different versions of the programme. To answer the research questions, the investigators will track engagement data digitally, conduct pre- and post-intervention surveys and observational assessments, and carry out a series of interviews and focus group discussions with key stakeholders: parents, teacher-facilitators, teacher-facilitators' supervisors, and leadership members of the Ministry of Rural Development (KEMAS) in Malaysia (the government department that are responsible for 33% of preschools in Malaysia, and those which this study focuses on).

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

208

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。

研究場所

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

Inclusion criteria for participating parents or caregivers:

  • Responsible for the child aged 4-6 years who is registered with KEMAS preschool
  • Aged 18 years or more
  • Lives in the same household with the child for at least four nights a month
  • Have access to a mobile phone compatible with WhatsApp
  • Gives consent to participate in the study

Exclusion criteria for participating parents or caregivers:

- Adult parents/caregivers with a severely limited mental capacity (either due to learning disability or acute mental health disorder), which will be assessed by research assistants by way of a four-item checklist.

Inclusion criteria for child respondents:

  • Is enrolled in a KEMAS preschool
  • Is between the ages of 4 and 6
  • Parent gives consent for the child to participate in the study
  • Child gives verbal assent to participate in the study

Inclusion criteria for teachers:

  • Registered employee with KEMAS preschool
  • 18 years old and above
  • Diploma/certificate in Early Childhood Education (ECE) or equivalent
  • Give consent to participate in the study
  • Participated in training of intervention package
  • Available to deliver intervention package

Inclusion criteria for supervisors:

  • Registered supervisor with KEMAS
  • 18 years old and above
  • Have a diploma/certificate in Early Childhood Education (ECE) or equivalent
  • Agree to participate in the study
  • Participated in the training of the programme:
  • Facilitator Training workshop: for new facilitators to deliver the programme
  • Training of Trainers workshop: supervisors (who completed the facilitator training working) were trained to deliver future training to new facilitators.

Inclusion criteria for KEMAS leadership:

  • Federal or state administrative staff of the Division of Early Childhood Education within KEMAS
  • 18 years old and above
  • Agree to participate in the study

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：他の
  • 割り当て：ランダム化
  • 介入モデル：階乗代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：1. ParentText + 1 in-person session
行動：Naungan Kasih Text (NKText) + onboarding session
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
実験的：2. ParentText + 1 in-person session + WhatsApp support
行動：Naungan Kasih Text (NKText) + onboarding session
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
行動：WhatsApp support groups
WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
実験的：3. ParentText + 2 in-person sessions
行動：Naungan Kasih Text (NKText) + onboarding session
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
行動：Closing session
An in-person closing session at the end of the intervention
実験的：4. ParentText + 2 in-person sessions + WhatsApp support
行動：Naungan Kasih Text (NKText) + onboarding session
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
行動：WhatsApp support groups
WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
行動：Closing session
An in-person closing session at the end of the intervention

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
Child Physical Abuse
時間枠：3 weeks post-intervention
International Society for the Prevention of Child Abuse and Neglect (ISPCAN) Child Abuse Screening Tool-Trial, physical abuse subscale (4 items) (0-8 times in last two weeks) - higher indicates more incidence of abuse (worse outcome)
3 weeks post-intervention
Child Emotional Abuse
時間枠：3 weeks post-intervention
Child emotional abuse: ISPCAN Child Abuse Screening Tool-Parent version, emotional abuse subscale (5 items) (0-8 times in last two weeks) - higher indicates more incidence of abuse (worse outcome)
3 weeks post-intervention
Playful Learning
時間枠：3 weeks post-intervention
United Nations Children's Fund Multiple Indicator Cluster Surveys child development module and family care indicators (4 items) (0-8 times in last two weeks) - higher indicates more playful learning activities (better outcome)
3 weeks post-intervention
Child Learning and Development
時間枠：3 weeks post-intervention

MELQO framework's Measure of Development and Early Learning module teacher or caregiver report item: Literacy and Numeracy subscales (0 = No, 1 = Yes) higher score indicates better outcome. Socio-emotional development and executive function 0-4 scale, mixture of higher score indicating better outcome and reverse coded items where higher score indicates worse outcome - needs recoding for analysis.

IDELA (8 overarching items, total 21 subitems), direct child assessment (0 = No, 1 = Yes) - higher score indicates better outcome.
3 weeks post-intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Parenting
時間枠：3 weeks post-intervention
Parenting Young Children Scale (supporting positive behavior, and setting limits; 14 items); (0-6); higher score indicates better outcome.
3 weeks post-intervention
Parent Mental Health
時間枠：3 weeks post-intervention
Patient Health Questionnaire-4 (4 items); 0-3; higher score indicates worse outcome
3 weeks post-intervention
Parenting Stress
時間枠：3 weeks post-intervention
Parenting Stress Scale (6 items); (0-5); higher score indicates worse outcome
3 weeks post-intervention
Child Behavior
時間枠：3 weeks post-intervention
Externalizing problems: Child and Adolescent Behavior Inventory, externalizing subscale (12 items); (0-2); higher score indicates worse outcome
3 weeks post-intervention
Gender equitable behaviors
時間枠：3 weeks post-intervention
Adapted from questionnaires used in previous violence prevention studies (4 items); (1-5); higher score indicates better outcome
3 weeks post-intervention
Marital health/quality
時間枠：3 weeks post-intervention
Marital Health Scale (5 items); (1-5); higher score indicates better outcome
3 weeks post-intervention
Financial Stress
時間枠：3 weeks post-intervention
Financial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome
3 weeks post-intervention
Quality of Life
時間枠：3 weeks post-intervention
Assessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome
3 weeks post-intervention

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

University of Oxford

協力者

Universiti Putra Malaysia

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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 (実際)

2023年7月1日

一次修了 (実際)

2024年3月31日

研究の完了 (実際)

2024年3月31日

試験登録日

最初に提出

2026年5月5日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月18日

QC基準を満たした最後の更新が送信されました

2026年5月13日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • R88954/RE001
  • 10.17605/OSF.IO/F32KY (レジストリ識別子：Prospectively registered on Open Science Framework on 05/12/23; ClinicalTrials.gov entry retrospective and consistent.)

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

De-identified individual participant data underlying the results reported in publications, including demographic variables, caregiver-reported outcomes, and child assessment outcomes.

IPD 共有時間枠

Deidentified participant data will be available beginning 12 months after publication of the planned article publication to allow completion of planned secondary analyses by the study team; no end date for availability.

IPD 共有アクセス基準

Requests for access will require submission of a brief description of the intended use. Requests will be reviewed by the study team. Access will be granted following approval of the request and completion of appropriate data access procedures.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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いいえ

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