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.: PACTR201710002621271 Date of Registration: 13/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Bridge to Empower Girls in Nairobi
Official scientific title Evaluation of effectiveness of positive parenting skills among teenage mothers in underserved settlements in Nairobi
Brief summary describing the background and objectives of the trial The main objective is to provide 500 teenage girls aged 15-19 years who are pregnant and/or have children the ages 0-3 years living in the Slums of Nairobi Eastlands with knowledge and skills to promote their children's physical, mental and emotional development, and assess changes in parental outcomes (knowledge, attitudes, practices, access to services)and child developmental outcomes (using 'Ages & Stages' Questionnaire'.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) BEGIN
Disease(s) or condition(s) being studied Early Childhood Development,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 22/05/2017
Actual trial start date 13/09/2018
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 628
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
U1111-1201-9595 - Universal trial number WHO
GERC/012/018/2017 GREAT LAKES UNIVERSITY OF KISUMU
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
Non-randomised This is a quasi-experiment. An intervention is enrolled and provided with interventions for a 12-15 months. For ethical reasons, the control group is enrolled after the 15 months and matched with a sample size from the intervention group. The control group will be provided with services after the proof of concept. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Bridge to Empowere Girls in Nairobi training and services for 15 months 12-15 months 500 pregnant teenagers between 15-19 years old or have children less than 3 years are provided with parenting skills using an ECD curriculum. The curriculum involves 10, 2 hour workshops held at least 2 weeks apart. The 10 workshops cover different aspects of early childhood development and parenting skills. 128 Historical
Experimental Group Parental skills training and services for 15 months 12-15 months 500 pregnant teenagers between 15-19 years old or have children less than 3 years are provided with parenting skills using an ECD curriculum. The curriculum involves 10, 2 hour workshops held at least 2 weeks apart. The 10 workshops cover different aspects of early childhood development and parenting skills. 500 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All teenage girls aged 15-19yrs that are pregnant or have children below 3 years. Living in the slum/non-formal settlements For the intervention group - those with only one child and the child is 31 months and above at the time of recruitment. 15 Year(s) 19 Year(s) Female
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 30/08/2017 Great Lakes University of Kisumu
Ethics Committee Address
Street address City Postal code Country
Kisumu Kisumu 2224 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) Improved uptake of pre-natal and post-natal medical services by the targeted teenage girls. Measured at mid-time Measured at End-time
Primary Outcome 2) Improved psychosocial wellbeing of the teenage mothers Mid-time End-time
Primary Outcome 3) Improved education and employable skills of the teenage mothers. mid-time end-time
Primary Outcome 4) Improved economic and means of livelihood for the households of teenage mothers. End-time
Secondary Outcome 5) Improved development outcomes of the children Measured at endtime
Secondary Outcome 6) Improved physical growth of the children. End-time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mukuru Centre of Hope Mukuru Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada MaRS Centre, West Tower661 University Avenue, Suite 1720 Toronto ON M5G 1M1 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nicasius Kamani Gacharage, next to Gacharage Secondary School Nairobi 00100 Kenya Commercial Sector/Industry
Secondary Sponsor Roselyn Angela Nyakundi Gacharage, next to Gacharage Secondary School Nairobi 00100 Kenya Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Julius Nguku Gacharage, next to Gacharage Secondary School Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nicasious Kamani nicasius.kamani@hopewwkenya.org +0725990993 Gacharage, next to Gacharage Secondary School
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Operations Director, HOPE Worldwide Kenya
Role Name Email Phone Street address
Public Enquiries Tabitha Muia tabitha.muia@hopewwkenya.org +254725990993 Gacharage, next to Gacharage Secondary School
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Business Development Officer, HOPE worldwide Kenya
Role Name Email Phone Street address
Scientific Enquiries Roselyn Nyakundi roselyn-nyakundi@hopewwkenya.org +254725215465 Gacharage, next to Gacharage Secondary School
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya M&E Manager, HOPE worldwide Kenya
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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