Enhancing Early Language and Cognitive Development in Toddlers Through a Culturally Adapted Home-based Parent InterventionCAHBI-TNCT07233525
Home-Based Language and Cognitive Intervention for Arab Toddlers in Israel
A study testing Culturally Adapted Parent-Implemented Intervention and Child Health Education Sessions in people with Enhancing Early Language and Cognitive Development in Toddlers Through a Culturally Adapted Home-based Parent Intervention, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Enhancing Early Language and Cognitive Development in Toddlers Through a Culturally Adapted Home-based Parent Intervention
- What is being tested?
- Culturally Adapted Parent-Implemented Intervention and Child Health Education Sessions
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Community Health Centres - Northern, Central, and Southern Israel
Beersheba
Shir Shani, +972523917864, shir.shani@bsh.health.gov.il
About this study
Official title: 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.
Read the 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.
- Being tested
- Culturally Adapted Parent-Implemented Intervention, Child Health Education Sessions
- 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
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted Parent-Implemented InterventionBehavioural
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 Health Education SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Child Health Education Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Arabic-CDI total vocabulary score
Parent-reported receptive and expressive vocabulary.
Measured: Baseline to 1-month post-intervention
Change in the CAT-CLAMS total score
: Measures language, communication, problem-solving, and adaptive behaviours.
Measured: Baseline to 1-month post-intervention
Secondary outcomes (1)
Change in PEDS parental concern score
Parent reported developmental concerns
Measured: Baseline to 1-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enhancing Early Language and Cognitive Development in Toddlers Through a Culturally Adapted Home-based Parent InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233525
- Sponsor's protocol ID
- 0159-22-HYMC
- Acronym
- CAHBI-T
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slobodin O, et al. (2021). Cultural adaptation of early childhood interventions: A systematic review. Early Childhood Research Quarterly, 57, 1-14.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Home-Based Intervention to Improve Language and Cognitive Development in Arab Toddlers in Israel: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07233525
- Acronym / sponsor ID
- CAHBI-T / 0159-22-HYMC
- Keywords
- Early childhood intervention, Home-based intervention, Language development, Cognitive development, Developmental delay, Parents responsiveness, Low SES intervention, ecological
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child language and cognitive development | Experimental | Behavioral: Culturally Adapted Parent-Implemented InterventionEight 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 |
| Child Health Education | Active comparator | Behavioral: Child Health Education SessionsEight 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. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Adapted Parent-Implemented InterventionA 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. | Behavioural | Child language and cognitive development |
| Child Health Education SessionsEight 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. | Behavioural | Child Health Education |
Primary outcome
Change in Arabic-CDI total vocabulary score
Time frame: Baseline to 1-month post-intervention
Parent-reported receptive and expressive vocabulary.
Change in the CAT-CLAMS total score
Time frame: Baseline to 1-month post-intervention
: Measures language, communication, problem-solving, and adaptive behaviours.
1 secondary outcome
Change in PEDS parental concern score
Time frame: Baseline to 1-month post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- BackgroundSlobodin O, et al. (2021). Cultural adaptation of early childhood interventions: A systematic review. Early Childhood Research Quarterly, 57, 1-14.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Adapted Parent-Implemented Intervention and Child Health Education Sessions in people with Enhancing Early Language and Cognitive Development in Toddlers Through a Culturally Adapted Home-based Parent Intervention, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Mahajnah, Professor (+972506246959, MUHAMADMAH@hymc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Arabic-CDI total vocabulary score (time frame: Baseline to 1-month post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07233525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.