NCT05244161

Brief Summary

The quality of caregiving and the parent-child relationship is critical for early child development (ECD) and has been shown to be modifiable. This study evaluated an ECD project in Tanzania, assessing the effectiveness of radio messaging (RM) alone and a combined radio messaging/video job aids/ECD (RMV-ECD) intervention, using a two-arm pre-post design study, which enrolled a cohort of caregivers of children 0-24 months in four districts of Tabora region, following them for nine months. ECD radio messages were broadcast on popular stations at least 10 times/day reaching all study districts. In two districts, community health workers (CHW) trained in UNICEF's Care for Child Development package and used ECD videos in home- and facility-based sessions with caregivers. Five outcomes were used to assess the intervention effects: ECD knowledge, early stimulation, father engagement, responsive care, and environment safety. Additionally the effect of the training and video job aids on the quality of CHWs' counseling support was evaluated primarily using structured observation checklists of household visits and facility group counseling sessions with caregivers and their children. Qualitative data was collected from a subset of caregivers and CHW participating in the study to assess acceptability and other perceptions of the project.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

January 25, 2022

Last Update Submit

February 16, 2022

Conditions

Keywords

Early child developmentParentingMedia interventionCommunity health workersProgram evaluationCaregiver

Outcome Measures

Primary Outcomes (6)

  • Caregiver age appropriate early childhood development knowledge as assessed by responses to interview-administered questions

    Proportion of respondents scoring \<2 (poor knowledge) or 2-6 (good knowledge) to six questions (scoring 0-6 points) asking the caregiver to describe one specific way that a "caregiver can support a child's mental, emotional or physical development…" during pregnancy, from birth to six months, from 6-9, 9-12, and 12-24 months and 2-5 years of age. Caregiver responses coded correct or incorrect.

    9 months

  • Caregiver early childhood stimulation practices as assessed by responses to interview-administered questions adapted from UNICEF's Multiple Indicator Cluster Surveys

    Proportion of respondents scoring poor (\<50%) or good (equal or \>50%) to questions on stimulation. Caregivers of children under seven months could score up to three points for reporting that the mother, father, or other adult engaged the child in singing songs, taking the child outside, or playing with the child in the past week. Caregivers of children over seven months were asked three additional items (read books, told stories, name/count things with child) for a total of six points. The sum of the items for these two measures were then standardized to a 0-1 scale.

    9 months

  • Father engagement with the child as assessed by caregiver responses to interview-administered questions adapted from UNICEF's Multiple Indicator Cluster Surveys

    Proportion of respondents scoring \<2 (poor engagement) or 2-6 (good engagement) to questions on father engagement. Caregivers of children under seven months could score up to three points for reporting that the father engaged the child in singing songs, taking the child outside, or playing with the child in the past week. Caregivers of children over seven months were asked three additional items (read books, told stories, name/count things with child) for a total of six points. The sum of the items for these two measures were then standardized to a 0-1 scale.

    9 months

  • Responsive care as assessed by interviewer observations of how the caregiver engaged with the child during the interview using questions from the interview guide

    Proportion of respondents scoring \<5 (poor responsive care) or 5-6 (good responsive care) by observed by interviewers of how the caregiver engaged with the child during the interview. Observations consisted of four items totaling up to six points which included helping the child keep busy (0, 1), pointing out objects/naming things (scored as 0, 1), recognizing when the child needs help with something (0,1,2), and keeping the child in view at all times (0,1,2).

    9 months

  • Household environment risk as assessed by interviewer observation of the inner and outer household areas using questions from interview guide

    Proportion of respondent households scoring equal or \<0.3 (poor) or \>0.3 (good) to interviewer observations of household and neighborhood environment safety from risks of community (nearby road, bar/market, ditches); outside compound (open water source, unpenned animals, accessible sharp tools, chemicals or flammable materials, and unprotected cooking area); and inside household (accessible electric, medicine or cleaning chemicals, inappropriate toys). The environment risk outcome was standardized (0-1) to adjust for the different number of items in each group.

    9 months

  • Quality of CHWs counseling assessed by independent observations of home and clinic counseling sessions against a checklist

    Proportion of CHWs scoring \<15 or (poor) equal or \>16 (good) on quality of home and clinic counseling at baseline and endline from video observations based on a 23-item checklist assessing how CHW 1) introduce topic/session, 2) educate on appropriate activities, 3) ask caregivers about behaviors, 4) plan and problem-solve, 5) interact with and encourage caregivers, and 6) discuss responsive care. Items with yes" or "no" response options were scored as "1" or "0", and items with "well done," "partly" or "not done" responses were scored "1," "0.5" or "0" points, respectively. Raw scores were then standardized to a 0-1 scale. Clinic and home observations scored separately and subsequently combined for an overall score.

    12-18 months

Secondary Outcomes (1)

  • Acceptability of ECD intervention activities as assessed through open-ended responses recorded in in-depth interviews with caregivers and focus group discussions with CHW.

    9-12 months

Study Arms (2)

Radio messaging (RM)

NO INTERVENTION

Radio messaging only (RM)

RM, Video job aids, Early Childhood Development program (RMV-ECD)

ACTIVE COMPARATOR

Radio messaging, short video job aids primarily for CHW use, and the UNICEF Care for Childhood Development program (RMV-ECD)

Behavioral: RMV-ECD

Interventions

RMV-ECDBEHAVIORAL

Combined radio messaging, video job aids (primarily for CHWs), Care for Childhood Development package

RM, Video job aids, Early Childhood Development program (RMV-ECD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • resident adult (\>18 years) primary caregiver of a child aged 0-24 months, and had the
  • intention to remain in the same area for at least one year,
  • willingness to be home-visited by a Community Health Worker.

You may not qualify if:

  • unable or unwilling to give informed consent
  • CHW eligibility criteria:
  • assigned to a Malezi II study health facility/catchment community
  • working as a Malezi II project CHW (i.e. attended Malezi (I or II) training, or capacitated for Malezi II project through on-job training and mentoring)
  • able to understand and willing to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elizabeth Glaser Pediatric AIDS Foundation

Dar es Salaam, Tanzania

Location

Related Publications (1)

  • Antelman G, Ferla J, Gill MM, Hoffman HJ, Komba T, Abubakar A, Remes P, Jahanpour O, Mariki M, Mang'enya MA, van de Ven R. Effectiveness of an integrated multilevel early child development intervention on caregiver knowledge and behavior: a quasi-experimental evaluation of the Malezi program in Tanzania. BMC Public Health. 2023 Jan 4;23(1):19. doi: 10.1186/s12889-022-14956-2.

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 17, 2022

Study Start

October 13, 2019

Primary Completion

March 31, 2021

Study Completion

June 30, 2021

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations