Scaling up an early childhood intervention by integrating into health services in rural Bangladesh

Last registered on September 29, 2020

Pre-Trial

Trial Information

General Information

Title
Scaling up an early childhood intervention by integrating into health services in rural Bangladesh
RCT ID
AEARCTR-0006536
Initial registration date
September 29, 2020

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 29, 2020, 7:31 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
Bangor University

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2018-01-01
End date
2019-07-31
Secondary IDs
Abstract
We have previously demonstrated that parent-training sessions conducted by government health workers, as part of their existing duties, in primary health care clinics in rural Bangladesh leads to large benefits to the level of stimulation in the home and to the development of disadvantaged young children. However, in previous studies, the research team trained and supervised the government workers. For the intervention to be implemented at scale, we need a feasible and effective model for the training and supervision of clinic health staff using the government supervisors and trainers. In this feasibility study, we evaluated the effectiveness of utilising government supervisors to train and supervise clinic staff to implement the intervention. We evaluated this approach using two measures: observed quality of parent-training sessions and the parenting practices of participating mothers. A key issue when integrating early childhood development programmes into existing services is that staff may be overburdened. Hence, we also measured burn-out among clinic staff.

The study was conducted in sixteen unions in rural Bangladesh. Eight unions (24 clinics) were randomly assigned to an intervention group and eight unions (24 clinics) to a control group. In intervention clinics, twenty-four mothers of children aged 6-36 months, living within a thirty minute walk from the clinic were invited to participate in fortnightly play sessions, delivered by government health staff in the clinic, in groups of four mother/child dyads. The effect of the play sessions was evaluated on the level of stimulation in the home by maternal report. The evaluation sample consisted of 384 mother/child dyads (192 intervention and 192 control). Burn out of health staff was also assessed in both intervention and control clinics. We also measured the quality of the parenting sessions in intervention clinics through observation.
External Link(s)

Registration Citation

Citation
Baker-Henningham, Helen. 2020. "Scaling up an early childhood intervention by integrating into health services in rural Bangladesh." AEA RCT Registry. September 29. https://doi.org/10.1257/rct.6536
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Experimental Details

Interventions

Intervention(s)
Government staff in community clinics conduct fortnightly parenting sessions with groups of four mother/child dyads for six months. The parenting sessions involve supporting mothers to play and talk with their child using low-cost play materials.
Intervention Start Date
2018-04-01
Intervention End Date
2019-01-31

Primary Outcomes

Primary Outcomes (end points)
Stimulation in the home
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Clinic staff burn-out
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The study is two-armed cluster randomized trial. Sixteen unions in rural Bangladesh were randomly assigned to an intervention (n=8) or control (n=8) group. Each union has three community clinics, giving a total of 48 clinics (24 intervention, 24 control).
The participants are mothers of children aged 6-30 months living within a thirty-minute walking distance from a participating community clinic in rural Bangladesh and government health staff attached to those clinics.
In intervention clinics, mother/child dyads are invited to attend fortnightly play sessions, delivered by government staff in the community clinic for six months. Mother/child dyads assigned to the control group receive no play sessions.
Twenty-four mother/child dyads from 24 intervention clinics were recruited into the intervention (to give a total of 576 mother/child dyads). A random sample of twelve mothers from two randomly selected clinics in each of the eight regions were included in the evaluation sample (n=192).
In the unions allocated to the control group, two clinics in each region were randomly selected and twelve mothers of children aged 6-30 months, living within a 30-minute walk from the clinic were recruited (n=192).
All health staff in the 48 clinics participating in the study were recruited (65 intervention, 65 control). In intervention clinics only, these staff implemented parenting sessions. All health staff answered questionnaires on professional burnout.


Experimental Design Details
Randomization Method
Randomization done in office by a computer
Randomization Unit
Unions
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
16 unions were randomized to intervention or control. Each union has 3 health clinics, giving a total of 48 clinics (24, intervention, 24 control).
Sample size: planned number of observations
576 mother/child dyads, 65 clinic health staff, 24 government health clinics, 19 government supervisors were involved in intervention implementation  48 community clinics, 125 clinic health staff, 384 mother/child dyads were included in the evaluation
Sample size (or number of clusters) by treatment arms
A subsample of mother/child dyads were selected for inclusion in the evaluation.
Two clinics from each union and 12 mother/child dyads from each clinic were randomly selected to participate in the evaluation giving a total of 192 mother/child dyads per group.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
With 24 mother/child dyads per clinic, with 85% power and at the 0.05 level of significance and assuming an intracluster correlation coefficient of 0.05, a sample size of 162/group is required to detect an effect size of 0.5SD. To allow for loss, we recruited 192/group. Hence, we could detect an effect size of 0.5SD on the primary outcome of stimulation in the home, with 85% power and at the 0.05 level of significance.
IRB

Institutional Review Boards (IRBs)

IRB Name
iccdr,b
IRB Approval Date
2017-10-24
IRB Approval Number
Protocol number: 17096

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
July 31, 2019, 12:00 +00:00
Data Collection Complete
No
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials