Effects of dialogic booksharing intervention in rural Tanzania
| ISRCTN | ISRCTN12613329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12613329 |
| Secondary identifying numbers | IGA_PrF_2023_028 |
- Submission date
- 21/06/2023
- Registration date
- 23/06/2023
- Last edited
- 30/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study evaluates the effects of dialogic booksharing, a parenting program for female caregivers of children aged between 15 and 45 months, implemented in rural areas of Southwest Tanzania. Female caregivers are trained to interact with children over picture books to enhance the child's cognitive and socio-emotional development. The study aims to assess the impact of dialogic booksharing intervention on a group of child and caregiver outcome measures. Children from diverse socio-economic backgrounds living in the target region will be included, in order to investigate possible differences in outcomes for differently-situated children.
Who can participate?
Women who are caring for a small child (born between 1st December 2019 and 1st June 2022). The woman does not need to be the child's biological mother.
What does the study involve?
Caregivers are randomly allocated to one of three groups.
Caregivers in the intervention group will participate in an 8-week-long dialogic booksharing program in groups of roughly ten people. After the eight weekly educational sessions, groups are encouraged to continue meeting twice a month, swapping books and sharing their experience with dialogic booksharing and the upbringing of children. To increase the motivation of female caregivers to continue the meetings, we support them in establishing charitable savings groups with a saving cycle of ten months.
In the active control group, female caregivers attend eight weekly workshops in groups of ten people focused on playful activities for children and on producing low-cost toys that help develop fine and gross motor skills. After 8 weeks, caregivers are encouraged to continue their meetings. The researchers support them in establishing charitable savings groups with a saving cycle of ten months.
The passive control group is on the waiting list until the intervention is finished. After that, the passive control group is provided with the intervention.
The researchers compare the following outcome measures for the intervention and both control groups: child variables: receptive and expressive language, ability to hold attention, emotion recognition, pro-social behavior, behavioral difficulties, and health; caregiver variables: parental stress, parenting practices, and active engagement with children; caregiver-child variable: caregiver-child relationship.
Data collection takes place at the start, immediately after the intervention, and 1 year after the start of the intervention. If these assessments confirm a difference in outcomes between intervention and control groups, the researchers plan to conduct a follow-up study to assess the long-term effects of the intervention. They expect the data collection for this follow-up study to be done in 3-5-year intervals.
What are the possible benefits and risks of participating?
Possible benefits for children are improved receptive and expressive language, improved ability to hold attention, improved emotion recognition, increased pro-social behavior, decreased behavioral difficulties, and improved health. Possible benefits for caregivers are lower parental stress, improved parenting practices, and more active engagement with children. The researchers also expect that both caregiver and child will benefit from the improved relationship. Activities within the project can be time-consuming and can thus limit caregivers in their daily activities. No other negative effects are anticipated.
Where is the study run from?
1. Palacký University Olomouc (Czech Republic)
2. Dar es Salaam University College of Education (Tanzania)
When is the study starting, and how long is it expected to run for?
March 2023 to September 2024
Who is funding the study?
Palacký University Olomouc (Czech Republic)
Who is the main contact?
1. Dr Martin Schlossarek, martin.schlossarek@upol.cz
2. Dr Eva Šerá Komlossyová, eva.serakomlossyova@upol.cz
Contact information
Principal Investigator
17. listopadu 12
Olomouc
77900
Czech Republic
 ORCID ID |
0000-0003-4212-4573 |
|---|---|
| Phone | +420 (0)585 634 988 |
| martin.schlossarek@upol.cz |
Public
17. listopadu 12
Olomouc
77900
Czech Republic
| ORCID ID |
0000-0002-8685-2129 |
|---|---|
| Phone | +420 (0)585 634 980 |
| eva.serakomlossyova@upol.cz |
Scientific
17. listopadu 12
Olomouc
77900
Czech Republic
| Phone | +420 (0)585 634 980 |
|---|---|
| eva.serakomlossyova@upol.cz |
Study information
| Study design | Three-arm interventional cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Childcare/pre-school, Community, Home |
| Study type | Quality of life, Treatment, Efficacy |
| Study type | Participant information sheet |
| Scientific title | Effects of Dialogic Booksharing intervention on the cognitive and socio-emotional development of toddlers and on parenting of female caretakers in rural Tanzania (EDBiT) |
| Study acronym | EDBiT |
| Study objectives | Current study hypothesis as of 30/06/2023: 1. Children participating in the Dialogic Booksharing intervention will evidence better improvement in the (receptive and expressive) language than children in the control groups. 2. Carers participating in the Dialogic Booksharing intervention will evidence better improvement in sensitivity and, together with their children, in reciprocity, than carers (and their children) in the control groups. Previous study hypothesis: 1. Children participating in the Dialogic Booksharing intervention will evidence better improvement in the receptive language in at least one of two measures of receptive language than children in the control groups. 2. Children participating in the Dialogic Booksharing intervention will evidence better improvement in the expressive language in at least one of two measures of expressive language than children in the control groups. |
| Ethics approval(s) |
Approved 31/05/2023, Ethics Committee, Faculty of Science, Palacký University Olomouc (17. listopadu 12, Olomouc, 771 46, Czech Republic; +420 (0)585634556; ivan.tuf@upol.cz), ref: 23-03 |
| Health condition(s) or problem(s) studied | Enhancing parenting competencies of female caretakers to boost the cognitive and socio-emotional development of children |
| Intervention | The intervention is an 8-week-long dialogic booksharing program for female caregivers and children aged between 15 and 45 months which aims to improve parental competencies in order to boost the cognitive and socioemotional development of children. After the eight weekly educational sessions in groups of roughly 10 people, groups are encouraged to continue meeting twice a month, swapping books and sharing their experience with dialogic booksharing and the upbringing of children. To increase the motivation of female caregivers to continue the meetings, the researchers support them in establishing charitable savings groups with a saving cycle of 10 months. They also send them motivational short messages to encourage participation in the meetings and sharing of feedback on applying principles of dialogic booksharing and the upbringing of children. In the active control group, female caregivers attend eight weekly workshops focused on playful activities for children and on producing low-cost toys that help develop fine and gross motor skills. Analogically to the intervention group, after 8 weeks, caregivers in groups of roughly 10 people are encouraged to continue their meetings. The researchers support them in establishing charitable savings groups with a saving cycle of 10 months. They also send them motivational short messages to encourage participation in meetings and sharing of experiences with children's upbringing. The passive control group is on the waiting list until the intervention is finished. After that, the passive control group is provided with the intervention. Randomization is performed on the level of clusters, with each cluster being defined as caregivers from households less than 100 meters apart from each other. The researchers will use a stratified cluster randomization design to ensure a roughly equal distribution of children by age. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. The child's receptive language is assessed by the caretaker via the adjusted Toddler Language Scale, and by the experimental Pointing Vocabulary Test at baseline, after the 8-week program, and 1 year after the baseline. 2. The child's expressive language is assessed by the caretaker via the adjusted Toddler Language Scale, and by the experimental Expressive one-word picture vocabulary test at baseline, after the 8-week program, and 1 year after the baseline. |
| Secondary outcome measures | 1. The attention of the child is assessed by Early Childhood Vigilance Test (experiment) at baseline, after the 8-week program, and 1 year after the baseline. 2. The child's emotional recognition is assessed by the Emotion Recognition/Understanding Assessment (experiment) at the baseline, after the 8-week program, and 1 year after the baseline. 3. Pro-social behavior of the child is assessed by the Prosocial scale of SDQ (questionnaire filled by the caretaker) and Help Task (experiment) at the baseline, after the 8-week program, and 1 year after the baseline. 4. The caregiver-child relationship is assessed by reciprocity analysis based on Female caregiver-child booksharing (experiment) after the 8-week program and 1 year after the baseline. 5. Child behavior is assessed by the total difficulties score of SDQ (questionnaire) after the 8-week program and 1 year after the baseline. 6. Parental stress is assessed by Parental Stress Scale (questionnaire) after the 8-week program and 1 year after the baseline. 7. Positive and negative parenting is assessed by Parenting Styles and Dimensions Questionnaire after the 8-week program and 1 year after the baseline. 8. The engagement of parents in playful activities with children is assessed by diaries during the program. 9. Children's health is assessed by the incidence of diarrhea, wasting, stunting, and underweight after the 8-week program and 1 year after the baseline |
| Overall study start date | 01/03/2023 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Carer, Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Months |
| Upper age limit | 45 Months |
| Sex | Both |
| Target number of participants | 295 participants distributed in clusters of 1 to 3 people. Expected number of clusters is roughly 145. |
| Key inclusion criteria | 1. The child has the correct age (born between 01/12/2019 and 01/06/2022) 2. The primary female caregiver of the child gave her consent to participate in the study 3. The female caregiver declared she could attend the baseline assessment, the intervention sessions, and the post-intervention assessments 4. The female caregiver agreed that we could delay their participation in the project by 1 year |
| Key exclusion criteria | 1. Specific health conditions of children that do not allow their active participation in the intervention 2. Specific health conditions of caregivers that do not allow their active participation in the intervention |
| Date of first enrolment | 01/07/2023 |
| Date of final enrolment | 31/08/2023 |
Locations
Countries of recruitment
- Tanzania
Study participating centre
Mahango - Mswiswi
53607
Tanzania
Sponsor information
University/education
Křížkovského 511/8
Olomouc
77900
Czech Republic
| Phone | +420 (0)585 631 111 |
|---|---|
| e-podatelna@upol.cz | |
| Website | http://www.upol.cz/en/ |
"ROR" |
https://ror.org/04qxnmv42 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Palacký University Olomouc, Palacký University, Olomouc, Palacký University, UP
- Location
- Czech Republic
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and analyzed during the current study will be available upon request from the principal investigator Dr Martin Schlossarek (martin.schlossarek@upol.cz). Upon request, the researchers are open to sharing anonymized raw individual-level data collected in quantitative questionnaires and anonymized individual-level results of analyses of experiments. The datasets will be available approx. 2 months after the last round of data collection, in November 2024. The researchers request informed consent from all participants, please see the participant information sheet (https://docs.google.com/document/d/1WNuyFxOWDxuHzp9Q41KZDvhVjNKbF-txDMp1DtHBwEo/edit?usp=sharing). Participation in the study is strictly voluntary. All the collected data are anonymized to protect the identity of research participants. All the audio and video recordings obtained during the data collection are securely stored and accessible only to the researchers conducting the analysis of these recordings. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 22/06/2023 | No | Yes |
Editorial Notes
30/06/2023: The study hypothesis was changed.
22/06/2023: Study's existence confirmed by the Ethics Committee, Faculty of Science, Palacký University Olomouc.
