Early parent-child intervention with Dialogic Book-Sharing and its benefits on child development and parenting
| ISRCTN | ISRCTN11755019 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11755019 |
| Secondary identifying numbers | NP 5205 |
- Submission date
- 20/10/2023
- Registration date
- 02/11/2023
- Last edited
- 16/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The study is evaluating a parenting intervention programme delivered to families in Italy. This programme involves training parents to share picture books with their children, employing techniques such as pointing and naming things on a page and following the child’s interest. The programme uses ‘dialogic’ book-sharing techniques – that is, it encourages and supports the child’s active involvement in a two-way interchange about the book. It is thought that such techniques will, in addition to leading to improvements in the child’s cognitive development and certain and aspects of parenting, be of benefit in terms of child self-regulation and behaviour. This study investigates to see whether DBS programme results in a number of benefits including improvements in the child’s language and attention skills and good behaviour and also with the parents interactions with their children compared to families that do not receive the intervention.
Who can participate?
Parents of children aged between 14-20 months.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are enrolled in the programme. Those in group 2 are placed on a waitlist, which means that they have no intervention from the research team until the study period is finished, after which they will receive the programme. The intervention consists of 60-90 minute sessions run weekly for 4 consecutive weeks, delivered to groups of parents and their children. The sessions include group and individual activities and make use of teaching materials, including PowerPoint slides, videos to illustrate particular learning points, and practical exercises. The facilitators who deliver the programme provide instruction aimed at promoting good book-sharing skills. As part of the programme, at the end of each weekly session, parents receive a ‘picture book of the week’ to take home with them. Parents are encouraged to apply what they have learned during the session with their children at home using the picture book.
What are the possible benefits and risks of participating?
Discussing parenting experiences and other topics in the intervention sessions and the assessments may cause emotional discomfort to some participants. In the event that participants show signs of distress or concern, these will be explored and, where appropriate, staff will arrange referral to local counselling and health services. Previous research suggests that the book-sharing training programme will be of benefit to the development of the great majority of children, in terms of their language and attention; and the quality of interactions between parents and their children is also likely to improve. Should this study achieve its aims, it will provide evidence for the benefit of a cost-effective community-based intervention for the promotion of child cognitive, social and emotional development.
Where is the study run from?
Observatory of Perinatal Clinical Psychology, Department of Clinical and Experimental Sciences, University of Brescia (Italy)
When is the study starting and how long is it expected to run for?
September 2022 to December 2025
Who is funding the study?
Observatory of Perinatal Clinical Psychology, Department of Clinical and Experimental Sciences, University of Brescia (Italy)
Who is the main contact?
Professor Loredana Cena, loredana.cena@unibs.it
Contact information
Public, Scientific, Principal Investigator
Observatory of Perinatal Clinical Psychology
Department of Clinical and Experimental Science
University of Brescia
viale Europa 11
Brescia
25123
Italy
 ORCID ID |
0000-0002-3162-9237 |
|---|---|
| Phone | +39 303717274 |
| loredana.cena@unibs.it |
Study information
| Study design | Single centre individual randomized controlled trial design with wait-list control group |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Early parent-child intervention with Dialogic Book-Sharing: effects on parenting and child communicative and socio-emotional development |
| Study objectives | Dialogic Book-Sharing programme delivered to parents has an effect on: b) increasing the child's linguistic, cognitive, attention and behavioural development; a) enhancing parent-child interaction; c) improving the parent's mood (anxiety, depression, and stress) and d) decreasing amount of screen time compared to an increase in parent-child book sharing at home |
| Ethics approval(s) |
Approved 27/09/2022, Ethics Committee of Spedali Civili, Brescia (Piazzale Spedali Civili, 1, Brescia, 25123, Italy; +39 3039951; comitatoetico.documentazione@asst-spedalicivili.it), ref: NP 5205 |
| Health condition(s) or problem(s) studied | Parenting practices, and early childhood development (language, cognition, social and emotional learning) |
| Intervention | Participants are randomly allocated (using a random number generator) to either the index group or the control condition: 1. The intervention is a dialogic book-sharing programme. It is targeted at caregivers with children between the ages of 14-20 months at the time of baseline assessment. Primary caregivers attend sessions with their children over 4 weeks. A trained facilitator delivers the sessions, each of which focuses on different and incremental techniques for caregivers to apply during book sharing. Groups consist of 4 to 6 parents and their children. Each session consists of a presentation to the group of the principles relevant to that session (using PowerPoint slides and illustrative video material); and this group session ends with ‘the book of the week’, where the trainer discusses a book with the parents, highlighting how the book should be used at home. Finally, each parent is given 10 minutes of individual guidance in applying the session principles when book-sharing with their child. The parent and child leave with ‘the book of the week’ and parent are encouraged to spend at least 10 minutes a day sharing the book with their child. 2. A wait-list control group that does not receive any input from the research team during the intervention period, but they will receive the intervention programme upon completion of follow-up assessment. First baseline data collection before the intervention (approximately 30 minutes) Dialogic Book Sharing intervention: 4 weeks Second data collection after the intervention (approximately 30 minutes) Follow-up data collection after 6 months (approximately 30 minutes) |
| Intervention type | Behavioural |
| Primary outcome measure | In each assessment session (Baseline pre-treatment, Post-treatment and 6 months Follow-up), the parent is invited to participate in a video recording of a 5-minute parent-child interaction and asked to complete a self-report questionnaire taking approximately 30 minutes, including questions on: 1. Parent’s socio-demographic details (age, nationality, educational level, professional occupation, economic condition), and information about pregnancy and post-partum period; 2. Child's linguistic developement assessed using The MacArthur-Bates Communicative Development Inventory (CDI - Fenson et al., 2000); 3. Child behavior assessed with The Achenbach System of Empirically Based Assessment (ASEBA) Child Behavior Checklist 1½ -5 (Achenbach, 2001); 4. Parental mood (anxiety, depression, stress) assessed with the Hospital Anxiety and Depression Scale (HADS Zingmond and Snaith (1983) and the short form of the parenting Stress Index (PSI-SF; Abidin, 1995). |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 20/09/2022 |
| Completion date | 19/12/2025 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 176 infant-caregiver dyads |
| Key inclusion criteria | 1. Mothers and fathers who are able to speak and read Italian 2. Children aged 14-20 months at the time of the baseline assessment |
| Key exclusion criteria | 1. Children who have a diagnosed physical or intellectual impairment; 2. Mothers and/or fathers with a diagnosed physical or psychiatric condition that could compromise their ability to participate in the intervention program. |
| Date of first enrolment | 24/03/2023 |
| Date of final enrolment | 19/12/2025 |
Locations
Countries of recruitment
- Italy
Study participating centre
viale Europa 11
Brescia
25123
Italy
Sponsor information
University/education
Observatory of Perinatal Clinical Psychology, Department of Clinical and Experimental Sciences
viale Europa 11
Brescia
25123
Italy
| Phone | +39 303717274 |
|---|---|
| loredana.cena@unibs.it | |
| Website | https://www.unibs.it/it/node/988 |
"ROR" |
https://ror.org/02q2d2610 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- University of Brescia
- Location
- Brazil
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | We will publish the findings of this study in peer-reviewed international journals and present them at national and international conferences. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 16/06/2024 | 19/06/2024 | Yes | No |
Editorial Notes
16/01/2025: The following changes were made to the trial record:
1. The overall end date was changed from 20/12/2024 to 19/12/2025.
2. The recruitment end date was changed from 20/12/2024 to 19/12/2025.
3. The plain English summary was updated to reflect these changes.
19/06/2024: Publication reference added.
23/10/2023: Trial's existence confirmed by Ethics Committee of Spedali Civili, Brescia.
