Home-Based Language and Cognitive Intervention for Arab Toddlers in Israel (CAHBI-T)

November 14, 2025 updated by: Hillel Yaffe Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Primary outcomes are changes in language and cognitive development, assessed with the CAT-CLAMS and the Arabic adaptation of the MacArthur-Bates Communicative Development Inventories (CDI). Secondary outcomes include caregiver-reported developmental concerns measured by the Parents' Evaluation of Developmental Status (PEDS). Assessments occur at baseline and one month post-intervention by blinded evaluators.

This trial will provide critical evidence regarding culturally adapted, parent-implemented interventions in marginalised populations. By addressing the ecological context of Arab families in Israel, the program aims to strengthen early language and cognitive skills, reduce risk of later academic and social difficulties, and contribute to the evidence base for scalable early developmental interventions.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Beersheba, Israel
        • Community Health Centres - Northern, Central, and Southern Israel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Child language and cognitive development

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
Behavioral: Culturally Adapted Parent-Implemented Intervention
A culturally adapted, parent-implemented home program designed to enhance toddlers' language, communication, and problem-solving skills. Trained facilitators deliver eight weekly 30-45-minute sessions in the family's home. Sessions focus on three everyday contexts-play, daily routines, and shared story time. Parents are guided to optimise the home environment, follow the child's interests, and use responsive interaction strategies such as joint attention, labelling, expansions, imitation, questioning, and scaffolding. Sessions progress from play-based interaction to integration into routines and storytelling.
Active Comparator: Child Health Education
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.
Behavioral: Child Health Education Sessions
Eight weekly home-based sessions delivered by trained facilitators, focusing on child health and wellbeing (nutrition, sleep, safety, vaccination, and toilet training). Sessions match the intervention arm in frequency, duration, and contact time but do not include language or cognitive stimulation components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Arabic-CDI total vocabulary score
Time Frame: Baseline to 1-month post-intervention
Parent-reported receptive and expressive vocabulary.
Baseline to 1-month post-intervention
Change in the CAT-CLAMS total score
Time Frame: Baseline to 1-month post-intervention
: Measures language, communication, problem-solving, and adaptive behaviours.
Baseline to 1-month post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PEDS parental concern score
Time Frame: Baseline to 1-month post-intervention
Parent reported developmental concerns
Baseline to 1-month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Collaborators

Ben-Gurion University of the Negev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Slobodin O, et al. (2021). Cultural adaptation of early childhood interventions: A systematic review. Early Childhood Research Quarterly, 57, 1-14.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0159-22-HYMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: The full study protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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