Home-Based Language and Cognitive Intervention for Arab Toddlers in Israel

NCT07233525 | Not Yet Recruiting DMC

• 1 other identifier: 0159-22-HYMC
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Enhancing Early Language and Cognitive Development in Toddlers Through a Culturally Adapted Home-based Parent Intervention

Keywords

Early childhood intervention; Home-based intervention; Language development; Cognitive development; Developmental delay; Parents responsiveness; Low SES intervention; ecological; CAT-CLAMS; Communicative Development Inventories (CDI); Arabic

Outcome Measures

Primary Outcomes (2)

• Change in Arabic-CDI total vocabulary score

  Parent-reported receptive and expressive vocabulary.

  Baseline to 1-month post-intervention

• Change in the CAT-CLAMS total score

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

  Baseline to 1-month post-intervention

Secondary Outcomes (1)

• Change in PEDS parental concern score

  Baseline to 1-month post-intervention

Study Arms (2)

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

Behavioral: Culturally Adapted Parent-Implemented Intervention

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.

Behavioral: Child Health Education Sessions

Interventions

Culturally Adapted Parent-Implemented Intervention BEHAVIORAL

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.

Child language and cognitive development

Child Health Education Sessions BEHAVIORAL

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.

Child Health Education

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

Community Health Centres - Northern, Central, and Southern Israel

Beersheba, Israel

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Muhammad Mahajnah, Professor

CONTACT

+972506246959; MUHAMADMAH@hymc.gov.il

Niveen Omar, Dr

CONTACT

+972525188615; nivin.omar13@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)