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Pilot Factorial Trial in Malaysia

13. Mai 2026 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

208

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Malaysia
      • Kuala Lumpur, Malaysia
        • Universiti Putra Malaysia

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 1. ParentText + 1 in-person session
Verhalten: 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
Experimental: 2. ParentText + 1 in-person session + WhatsApp support
Verhalten: 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
Verhalten: WhatsApp support groups
WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
Experimental: 3. ParentText + 2 in-person sessions
Verhalten: 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
Verhalten: Closing session
An in-person closing session at the end of the intervention
Experimental: 4. ParentText + 2 in-person sessions + WhatsApp support
Verhalten: 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
Verhalten: WhatsApp support groups
WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
Verhalten: Closing session
An in-person closing session at the end of the intervention

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Child Physical Abuse
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Parenting
Zeitfenster: 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
Zeitfenster: 3 weeks post-intervention
Patient Health Questionnaire-4 (4 items); 0-3; higher score indicates worse outcome
3 weeks post-intervention
Parenting Stress
Zeitfenster: 3 weeks post-intervention
Parenting Stress Scale (6 items); (0-5); higher score indicates worse outcome
3 weeks post-intervention
Child Behavior
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 3 weeks post-intervention
Marital Health Scale (5 items); (1-5); higher score indicates better outcome
3 weeks post-intervention
Financial Stress
Zeitfenster: 3 weeks post-intervention
Financial Self-Efficacy Scale (5 items); (0-3); higher score indicates worse outcome
3 weeks post-intervention
Quality of Life
Zeitfenster: 3 weeks post-intervention
Assessment of Quality of Life-4D (12 items); (1-4); higher score indicates worse outcome
3 weeks post-intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Oxford

Mitarbeiter

Universiti Putra Malaysia

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2023

Primärer Abschluss (Tatsächlich)

31. März 2024

Studienabschluss (Tatsächlich)

31. März 2024

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Mai 2026

Zuerst gepostet (Tatsächlich)

18. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • R88954/RE001
  • 10.17605/OSF.IO/F32KY (Registrierungskennung: Prospectively registered on Open Science Framework on 05/12/23; ClinicalTrials.gov entry retrospective and consistent.)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

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-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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