Do video materials help parents to support toddler development?

Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: This study is designed to evaluate a digital service for parents based around BBC Education's Tiny Happy People video content (see: https://www.bbc.co.uk/tiny‐happy‐people). This service has been designed to operate over three waves ‐ infancy, toddlerhood and preschool and this study is focused on the toddler wave. Participants for this study are drawn from a prior, completed RCT testing the efficacy of the infancy phase of the service (infants aged 6‐24 months). The current pilot will test the toddler phase. If willing, the same families will be retained to participate in this phase, staying in the same condition they were originally allocated to a language intervention or an active control. All families taking part in this original ‘infancy phase’ evaluation were eligible for and invited to the current ‘toddler phase’ study. The design is as follows: Study Design Study Type: Interventional Primary Purpose: Basic Science Study Model: Parallel Assignment Number of Arms: 2 Masking: Quadruple (Participant, Caregiver, Investigator, Outcomes Assessor) Text messages are sent blind to condition. SLT support is only given to one condition so no chance for bias. Allocation: Randomized All participants were recruited prior to randomisation with parallel assignment using computer‐generated random numbers. Poststratification based on 24 groups was created by crossing caregiver education (two levels ‐ higher and lower), ASQ (two levels ‐ higher and lower), se X(two levels ‐ M/F) and age (si Xlevels ‐ 5, 6, 7, 8, 9 or 10 months at the start of intervention). The random sequence of values (0 or 1) was generated by Colin Bannard (University of Mancheste CONDITION: Language development in early childhood (2.5 to 4 years) in socioeconomically diverse children, and linguistic responsiveness on the part of their caregivers ; Not Applicable PRIMARY OUTCOME: ; 1. Engagement with the text message component of the intervention, measured by the percentage of links texted to participants that were clicked on by participants between November 2023 and May 2024.; 2. Engagement with the higher intensity video‐call component of the intervention, measured by the percentage of scheduled sessions attended by caregivers, recorded by research team members during the implementation period between November 2023 and May 2024.; SECONDARY OUTCOME: ; Feasibility of service delivery:; 1. Engagement with service measured by the number of participants opting to withdraw from the study by participants between November 2023 and May 2024; 2. Fidelity of Speech and Language Therapists’ implementation of 1‐1 video call sessions measured by the Quality of Interaction measure of Wickersham et al. (2011) between November 2023 and May 2024; ; Feasibility of service evaluation:; 3. Response to outcome questionnaires measured by the number of participants returning questionnaires between May 2024 and July 2024; 4. Response to request to share home videos via smartphones (to allow outcome measurement of interaction and child language) measured by the number of participants sharing a video between May 2024 and July 2024; 5. Response to request to book a home visit (for a researcher to collect child language outcome measures in person) as measured by the number of participants returning making an appointment between June 2024 and July 2024; 6. Presence for home visit (for a researcher to collect child language measures in person) as measured by the number of participants at home for outcome data collection appointment between June 2024 and July 2024; 7. Feasibility of collecting data using the ERB and the Language Screen in homes with 3 ½ year olds as measured by the number of participants for whom data could be collected between June 2024 and July 2024; ; Acceptability and fidelity of delivery:; 8. Acceptability of the text message component of the intervention to caregivers measured using a questionnaire based on the Sekhon et al. (2017) framework in May 2024; 9. Acceptability of the high‐intensity video‐call component of the intervention to caregivers measured using a questionnaire based on the Sekhon framework in May 2024; 10. Acceptability of the high‐intensity video‐call component of the intervention to SLT(s) delivering the language intervention measured using a questionnaire based on the Sekhon framework and by interview in May 2024; 11. Fidelity to the text message component of the intervention measured using the Quality of Interaction measure of Wickersham et al. (2011) in May 2024; ; NB. The researchers will also qualitatively analyse focus group data to aid the interpretation of findings.; ; If the study finds that the intervention is feasible following the primary outcome measures 1 and 2, and secondary outcome measures 1 to 11, further analyses focusing on the intervention efficacy will be conducted. For more details, including a full statistical analysis plan, please see the accompanying Open Science Foundation pre‐registration (https://osf.io/csqnk/).; ; The two primary efficacy analyses of interest (as the planned primary outcome measures in the potential full trial) are:; 12. Caregiver responsiveness measured using the Parental Responsiveness Rating Scale (PaRRiS) in June 2024 and July 2024; 13. Child language measured using a composite score of child language ability measured using a combination of the ERB, the Language Screen, and naturalistic measures (word tokens, word types and Mean Length of Utterance), in June 2024 and July 2024; ; The secondary efficacy analyses are:; 14. Specific caregiver responsive strategies measured using an existing reliable coding scheme (see https://osf.io/preprints/psyarxiv/4h36e) in May 2024; 15. Child Pragmatics and Pre‐literacy measured using the Clinical Evaluation of Language Fundamentals ‐ Preschool 2 questionnaire (CELF‐P2) in May 2024; 16. Caregiver self‐efficacy measured using a bespoke questionnaire in May 2024; 17. Caregiver mental health measured using the Kessler 6 questionnaire (Kessler 6) in May 2024; 18. Caregiver Capabilities, Opportunities, and Motivations measured using a survey created by Keyworth et al. (2020) in May 2024; 19. Dental health and diet outcomes measured using a bespoke questionnaire in May 2024; INCLUSION CRITERIA: Participants are included in this toddler‐wave evaluation if they were part of the prior infancy‐wave evaluation. The inclusion criteria for the original infancy‐wave evaluation were as follows: 1. Infants must be no younger than 4 months 2. Infants must be no older than 10 months 3. Infants must be full‐term 4. Infants must have a healthy birth weight 5. Families must be raising their child as a monolingual English speaker (at least 80% of the language they hear in the home is English) 6. Families must have a postcode in deciles 1‐5 of the Office of National Statistics Inde Xof Multiple Deprivation 7. Families must have access to the internet and a device to watch videos (via smartphone) 8. Participants (caregivers, infants) could be any sex/gender Inclusion criteria for this feasibility study: 9. Families must have taken part in the previous phase of the RCT
Epistemonikos ID: 0ad0bd6afbe26f05756f871f6f5dccb7fff7955a
First added on: Aug 26, 2024