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Pilot Factorial Trial in Malaysia

2026년 5월 13일 업데이트: 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).

연구 개요

연구 유형

중재적

등록 (실제)

208

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 1. ParentText + 1 in-person session
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
실험적: 2. ParentText + 1 in-person session + WhatsApp support
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
실험적: 3. ParentText + 2 in-person sessions
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
An in-person closing session at the end of the intervention
실험적: 4. ParentText + 2 in-person sessions + WhatsApp support
Naungan Kasih Text (NKText): A self-guided chatbot providing parenting support Onboarding session: an in-person session at the beginning of the intervention
WhatsApp groups facilitated by children's teachers, with other participating parents from the children's preschool classes
An in-person closing session at the end of the intervention

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Child Physical Abuse
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 7월 1일

기본 완료 (실제)

2024년 3월 31일

연구 완료 (실제)

2024년 3월 31일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 5월 13일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 13일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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