The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for a three-year cluster randomized controlled trial

Abstract

BackgroundThe negative effects of perinatal depression on the mother and child start early and persist throughout the lifecourse (Lancet 369(9556):145–57, 2007; Am J Psychiatry 159(1):43-7, 2002; Arch Dis Child 77(2):99–101, 1997; J Pak Med Assoc 60(4):329; J Psychosoma Res 49(3):207–16, 2000; Clin Child Fam Psychol Rev 14(1):1–27, 2011). Given that 10–35 % of children worldwide are exposed to perinatal depression in their first year of life (Int Rev Psychiatry 8(1):37–54, 1996), mitigating this intergenerational risk is a global public health priority (Perspect Public Health 129(5):221–7, 2009; Trop Med Int Health 13(4):579–83, 2008; Br Med Bull 101(1):57–79, 2012). However, it is not clear whether intervention with depressed women can have long-term benefits for the mother and/or her child. We describe a study of the effectiveness of a peer-delivered depression intervention delivered through 36 postnatal months, the Thinking Healthy Program Peer-delivered PLUS (THPP+) for women and their children in rural Pakistan.Methods/designThe THPP+ study aims are: (1) to evaluate the effects of an extended 36-month perinatal depression intervention on maternal and index child outcomes using a cluster randomized controlled trial (c-RCT) and (2) to determine whether outcomes among index children of perinatally depressed women in the intervention arm converge with those of index children born to perinatally nondepressed women. The trial is designed to recruit 560 pregnant women who screened positive for perinatal depression (PHQ-9 score ≥10) from 40 village clusters, of which 20 receive the THPP+ intervention. An additional reference group consists of 560 perinatally nondepressed women from the same 40 clusters as the THPP+ trial. The women in the nondepressed group are not targeted to receive the THPP+ intervention; but, by recruiting pregnant women from both intervention and control clusters, we are able to evaluate any carryover effects of the THPP+ intervention on the women and their children. Perinatally depressed women in the THPP+ intervention arm receive bimonthly group-based sessions. Primary outcomes are 3-year maternal depression and 3-year child development indicators. Analyses are intention-to-treat and account for the clustered design.DiscussionThis trial, together with the reference group, has the potential to further our understanding of the early developmental lifecourse of children of both perinatally depressed and perinatally nondepressed women in rural Pakistan and to determine whether intervening with women’s depression in the perinatal period can mitigate the negative effects of maternal depression on 36-month child development.Trial registrationTHPP-P ClinicalTrials.gov Identifier: NCT02111915 (registered on 9 April 2014).THPP+ ClinicalTrials.gov Identifier: NCT02658994 (registered on 21 January 2016).Sponsor: Human Development Research Foundation (HDRF).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1530-y) contains supplementary material, which is availabl...

Maternal depression in rural Pakistan: the protective associations with cultural postpartum practices

“…The study is representative of a typical low-socioeconomic rural area in the north of the Punjab Province. A more detailed description of the study is available elsewhere [21]. Briefly, pregnant women in 40 village clusters were identified and invited to be screened for depression using the Patient Health Questionnaire (PHQ-9).…”

“…Briefly, pregnant women in 40 village clusters were identified and invited to be screened for depression using the Patient Health Questionnaire (PHQ-9). Women who scored 10 or higher were invited to participate in the study; roughly one in three women who scored less than 10 were asked to participate in the study [21]. Given unequal probabilities of selection into the study, sampling weights were used to represent the population of pregnant women in the area [21].…”

“…Women who scored 10 or higher were invited to participate in the study; roughly one in three women who scored less than 10 were asked to participate in the study [21]. Given unequal probabilities of selection into the study, sampling weights were used to represent the population of pregnant women in the area [21]. Women were then followed up at three, six, 12, 24, and 36 months postpartum through inperson interviews.…”

What does social support sound like? Challenges and opportunities for using passive episodic audio collection to assess the social environment

“…For example, application and call logs have also been used to determine communication (44). In case of mother-child interaction, we suggest using additional observation tools such as HOME (27,45,46) and OMCI (47)(48)(49) which have been used in multi-cultural settings to assess mother and child's social environment, interactions and support. Finally, additional methods of passive data collection, such as Bluetooth beacons attached to child's clothing can help determine the time mother and child spend together (19,29).…”

Peer Review #1 of "Criterion-related validity and reliability of the Urdu version of the patient health questionnaire in a sample of community-based pregnant women in Pakistan (v0.2)"

“…Thinking Healthy Programme Peer-Delivered Plus (THPP+) cluster randomized trials (Duke University IRB approval #Pro00047609; Human Development Research Foundation IRB approval #IRB/2014/002 and #IRB/003/2016) (Sikander et al 2015;Turner et al 2016) The aim of these trials is to test the effect on perinatal depression of an extended and peerdelivered version of a previously successful intervention (Rahman et al 2008). All pregnant women, registered with community health workers (called Lady Health Workers) of the subdistrict Kallar Syedan, Rawalpindi District, Pakistan, were approached by study personnel and, after providing written (or witnessed, if illiterate) informed consent, screened for depression using the Urdu version of the PHQ-9.…”