Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202204697674974 Date of Approval: 19/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Drakenstein Book sharing trial
Official scientific title The impact of Dialogic Book-Sharing on Neurocognitive and Socio-emotional development; A Randomized Controlled Trial in a South African Cohort
Brief summary describing the background and objectives of the trial Caregivers and their children (aged 41- 43 months) were recruited at an appointment that formed part of the existing DCHS assessment schedule. Baseline receptive and expressive language, executive function, theory of mind and behaviour was measured. 122 Caregiver-infant dyads were randomly assigned to an intervention group (n = 61) or control group (n = 61). The 8-week parent training intervention programme consisted of weekly 90-minute sessions during which caregivers were taught and practiced dialogic book sharing with their children. Follow up assessments of the 4y old children took place 6 months after enrolment and consisted of a repetition of the measures performed at baseline.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 15/01/2018
Actual trial start date 09/04/2018
Anticipated date of last follow up 16/09/2019
Actual Last follow-up date 16/12/2019
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 122
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dialogic Book sharing Weekly session of 90 minutes 8 week training program The intervention consisted of 90-minute weekly sessions for eight consecutive weeks. The book-sharing intervention was conducted in the participants’ first language, where two trained facilitators, one isiXhosa speaking and one Afrikaans speaking, led the groups. The programme was delivered to groups of four to six dyads in local libraries. Each session consisted of a presentation with information on techniques and demonstration videos. The skills build on each other with progressively more complex concepts explored. Caregivers had the opportunity to practice book-sharing with one-on-one supervision. The sessions were designed to be interactive and positive so as to model the desired interaction between caregiver and child when book-sharing. For the first seven sessions there was a ‘book of the week’ where the families were given books to keep and to practice book-sharing at home for 10-15 minutes per day. Participants were given laminated memory cards with the week’s lessons and examples to collect in a provided file. In the final session, all the key principles were reviewed, and caregivers registered for library cards. Participants were encouraged to continue practicing their skills for 10-15 minutes per day with new books obtained from the library, second-hand bookshops or borrowed from each other. The control group received treatment as usual and were added to a waiting list to receive the intervention should the results be favorable. 61
Control Group Treatment as usual no duration, treatment as usual Treatment as usual - assigned to a waiting list to receive the intervention should it prove effective. Parents interacted with their children as they usually would and read books to them at similar levels to what they did before signing up to participate in the study. 61 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Capacity to provide informed consent Availability of parent / carer for 8 week training course during office hours Parent / carer to live with the child (Only children already enrolled in the larger cohort - the Drakenstein child health study - were eligible) Did not consent to participation Known neurodevelopmental delay Visual or hearing impairment Twins Preschool Child: 2 Year-5 Year 41 Month(s) 43 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/09/2017 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E52 - Room 46, E Floor, Old Main Building Groote Schuur Hospital Cape Town 7700 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/09/2017 UCT Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E53 - Room 46,Old Main Building Groote Schuur Hospital Observatory, 7925 Cape Town 7725 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/09/2017 UCT Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E53 - Room 46,Old Main Building Groote Schuur Hospital Observatory, 7925 Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/09/2017 UCT Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E53 - Room 46,Old Main Building Groote Schuur Hospital Observatory, 7925 Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Expressive and receptive Language Pre-intervention: age 42 months as well as Post-intervention: age 48 months
Secondary Outcome Executive function and attention Pre-intervention: age 42 months as well as Post-intervention: age 48 months
Secondary Outcome Theory of Mind Pre-intervention: age 42 months as well as Post-intervention: age 48 months
Secondary Outcome Internalising and externalising child behaviour Pre-intervention: age 42 months as well as Post-intervention: age 48 months
Secondary Outcome Parent-child relationship Pre-intervention: age 42 months as well as Post-intervention: age 48 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbekweni Clinic Matakata Street Paarl 7655 South Africa
TC Newman Clinic Corner or Rosary and Broadway Paarl 7646 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof Dan Stein Anzio Road Cape Town 7725 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Rondebosch Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Reading University Whiteknights Reading RG6 6AH United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dan Stein dan.stein@uct.ac.za 0214066566 Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Head of Department Psychiatry and Mental Health Faculty of Health Sciences
Role Name Email Phone Street address
Public Enquiries Karen Mare karentmare@gmail.com 0765746395 16 Bakker Street
City Postal code Country Position/Affiliation
Bellville 7530 South Africa Research fellow
Role Name Email Phone Street address
Scientific Enquiries Sheri Koopowitz sheri.koopowitz@uct.ac.za 0741016332 Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Research Fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Researchers who provide a methodologically sound proposal may be given access to data, beginning 3 months after and ending 2 years following article publication. The proposal should be directed to nadia.hoffman@uct.ac.za. To gain access, data requestors will need to sign a data confidentiality agreement Statistical Analysis Plan Up to 2 years Access criteria will be controlled and limited to secondary data analyses. Please contact Nadia Hoffman (nadia.hoffman@uct.ac.za) for the process of gaining access to the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information