Study Design

Contents

Setting

Recruitment

Trial Randomization

Assessment Timing

Studying The Effects of COVID-19

Setting
Participants reside in Rawalpindi, Pakistan in the 40 village clusters that comprise the rural Sub-District of Kallar Syedan.

Study Area

Recruitment of Study Participants
All pregnant women residing in the study area at the time of recruitment were screened for depression using the Patient Health Questionnaire Depression Scale (PHQ-9). All women scoring above 10 on the PHQ-9 were invited to join the cohort, while 1/3rd of those who did not meet the threshold were invited to participate. The final sample size at baseline was 1,154 women (584 non-depressed, 570 depressed). Women were excluded if they were un-married, did not reside in the study area, did not understand any of the study languages (Urdu, Punjabi, or Potohari), or needed immediate medical attention.

Trial Randomization
Embedded within the Bachpan birth cohort is the Thinking Health PLUS (THPP+) Program, a cluster-randomized trial for a peer-delivered psychosocial depression treatment. The delivery of the intervention was randomized at the village cluster level, such that 20 village clusters received the intervention, and 20 village clusters received enhanced usual care (EUC). For more information on the randomization of the participants, please reference the participant flow diagram below.

Assessment Timing 

After recruitment, women completed a set of baseline measures. Post-natal assessments are ongoing and have been completed at 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 72 months, and 84 months post-partum for all women not lost to follow-up. All assessments occurred in person except the 48-month interview which was conducted over the phone.

For more detailed information on the study design, please reference our protocol paper, published in Trials.

Studying the Effects of COVID-19

The Bachpan Study Group is interested in learning more about how the depression intervention given to the original Bachpan study cohort, together with COVID-19 stressors like economic shocks, health shocks, and uncertainty for the future, influence maternal and child (ages 6 to 8) mental health. This is also a unique opportunity to understand the development of children in a critical developmental period.

This study aims to:

measure the effects of sources of stress related to COVID-19, such as economic shocks and uncertainty, on the mental health of mothers and children,
investigate whether mothers who took part in the depression intervention experienced better mental health outcomes than mothers who did not get the intervention while exposed to stressors connected to the COVID-19 outbreak and
identify long-lasting effects of COVID-19 related stressors, the intervention, and their association to mother and child mental health four years after the pandemic started.