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临床试验/NCT07233525
NCT07233525尚未招募不适用

Culturally Adapted Home-Based Intervention to Improve Language and Cognitive Development in Arab Toddlers in Israel: A Randomised Controlled Trial

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
试验地点
1
主要终点
Change in Arabic-CDI total vocabulary score

研究概览

简要总结

This study evaluates the effectiveness of a culturally adapted, home-based program designed to improve language and cognitive development in Arab toddlers in Israel. Families with children aged 18-36 months will participate in eight weekly sessions delivered in their homes. The intervention teaches parents strategies to enhance their child's language, communication, and problem-solving through play, daily routines, and story time. A comparison group will receive eight sessions on child health promotion (nutrition, sleep, safety, etc.). Child outcomes will be assessed using the Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT-CLAMS) and the Arabic Communicative Development Inventories (CDI). This research aims to provide an evidence-based, scalable model for early childhood interventions in disadvantaged populations.

详细描述

Arab children aged 0-3 years in Israel are considered at high risk for cognitive, linguistic, and educational disadvantages due to structural and socio-cultural factors, including poverty, geographic and social marginalisation, and underutilization of daycare and health services. Despite evidence that early intervention supports language and cognitive development, few culturally adapted, evidence-based programs have been evaluated in this population.

This study evaluates a home-based, culturally adapted early childhood intervention designed to enhance language, communication, and problem-solving skills in Arab toddlers (18-36 months). The intervention is guided by Bronfenbrenner's ecological framework and emphasises caregiver responsiveness, considering the child's developmental characteristics, the caregiver's behaviour, and the family's physical and social environment.

The program consists of eight weekly sessions delivered in the family's home, focusing on three contexts: play, daily routines, and shared story time. Parents are guided to optimise the home environment, follow the child's interests, and use responsive behaviours such as joint attention, labelling, expansions, imitation, questioning, and scaffolding. Sessions progress from play-based strategies to generalisation in routines and storybook reading.

Families randomised to the control arm receive eight home-based health-promotion sessions, matched in frequency and duration, covering topics such as nutrition, sleep routines, vaccinations, and toilet training. This serves as an attention-control condition without direct cognitive or language stimulation.

Participants include children aged 18-36 months with no severe medical conditions, birth weight ≥1500g, and scores at the lower end of the normative range on the CAT-CLAMS (approximately -1 to -2 SD below the mean). Caregivers must agree to participate and must not show moderate-to-severe depressive symptoms (PHQ-9 ≥10). Recruitment will occur via community healthcare centres ("well-baby" clinics).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors conducting post-intervention evaluations will be blinded to group allocation. Participants and interventionists cannot be blinded due to the nature of the home-based behavioural intervention.

入排标准

年龄范围
18 Months 至 36 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-36 months
  • •Birth weight ≥1500 g
  • •No significant sensory impairments or severe medical conditions
  • •CAT-CLAMS scores at the lower end of the normative range (approximately -1 to 1.5 SD below mean)
  • •Caregiver willing to participate in eight home sessions
  • •Caregiver without moderate or severe depressive symptoms (PHQ-9 < 10)

排除标准

  • 未提供

研究组 & 干预措施

Child language and cognitive development

Experimental

Eight weekly home-based sessions focusing on:

  1. Optimising the physical environment
  2. Following the child's interests in play
  3. Enhancing parental responsiveness during exploration, play, and communication
  4. Integration into daily routines and story time

干预措施: Culturally Adapted Parent-Implemented Intervention (Behavioral)

Child Health Education

Active Comparator

Eight weekly sessions on topics such as healthy sleep, nutrition, toilet training, vaccinations, and safe routines. Same schedule and duration as the intervention arm but without language or cognitive stimulation.

干预措施: Child Health Education Sessions (Behavioral)

结局指标

主要结局

Change in Arabic-CDI total vocabulary score

时间窗: Baseline to 1-month post-intervention

Parent-reported receptive and expressive vocabulary.

Change in the CAT-CLAMS total score

时间窗: Baseline to 1-month post-intervention

: Measures language, communication, problem-solving, and adaptive behaviours.

次要结局

  • Change in PEDS parental concern score(Baseline to 1-month post-intervention)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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