Early language development in children aged 2-3 years Not Applicable
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Families must live within specified areas of Bradford 2. Families must have a child aged 2 to 2.5 years who is referred into the Talking Together programme following a screening assessment by a Language Development Worker (LDW) 3. Families must speak English, Urdu, or Punjabi at home 4. Families must be willing to receive the intervention delivered by a LDW in their home 5. Families must identify one parent/carer who will be the primary recipient of the programme, who will be present for all sessions 6. Families must be will to be randomly allocated to treatment or control group and consent to additional data collection if allocated to the control group 7. Families must be taking part in the programme voluntarily and not being required to receive Talking Together by an outside service e.g. Social Services
Exclusion criteria
Exclusion criteria: 1. Children who have any known significant developmental disorder or sensory impairment 2. Children who are older than 2yrs 6 months at assessment 3. Children who are not singletons (twins, triples) 4. Families where the primary carer/parent to whom the intervention programme will be delivered may vary from session to session
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 30/07/2019: The feasibility of a future, full-scale trial of the Talking Together programme: 1. Recruitment and retention of Talking Together by establishing the number of participants who were identified, eligible, approached, consented, randomised, completed the programme, and followed up 6 months after baseline [within 24 months of the beginning of the start date] 2. Representativeness of those participants eligible and recruited to the trial as compared to the wider population receiving the intervention based on key demographic indicators [within 18 months of the beginning of the start date] 3. Acceptability of the intervention and trial procedures for practitioners and families, including randomisation and completion of outcome measures [within 24 months of the beginning of the start date] 4. The most appropriate primary outcome measure for future full-scale RCT by considering the acceptability, reliability, and data quality (completeness) of currently administered outcome measures [within 24 months of the beginning of the start date] 5. Fidelity to the standardised procedures by assessing the intervention content, and the frequency and duration of support received by participants [within 18 months of the beginning of the start date] 6. Barriers and facilitators to engagement with the intervention and the trial [within 18 months of the beginning of the start date]. 7. Time and resources required to train practitioners to administer the intervention, in order to make appropriate recommendations for resource requirements for full-scale RCT development [within 18 months of the beginning of the start date] 8. Intervention completion and attrition rates, along with outcome data group differences and variability across conditions, to inform sample size calculations for full-scale trial [within 30 months of the beginning of the start date] The feasibility trial has the following progression/continuation criteria, and the result | — |
Secondary
| Measure | Time frame |
|---|---|
| The outcome measures under consideration as part of the feasibility trial are all collected at pre-test and at 2 months (post-test) and 6 months (follow-up) post pre-test. All measures will be used throughout the recruitment phase with all participants: 1. Parent-child relationship, assessed using the Maternal Objects Relations Scale (MORS) 2. Home learning environment, assessed using the Home Learning Environment Questionnaire (HLEQ) 3. Child behaviour, assessed using the Strengths and Difficulties Questionnaire (SDQ) 4. Child vocabulary, assessed using Oxford Communicative Development Inventory, Short From (CDI) 5. Child broader language, assessed using the WellComm Assessment | — |
Countries
England, United Kingdom