NCT04252807

A Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction

Completed NA Last updated 3 August 2022

What this trial tests

NA trial testing Intervention arm in Maternal Distress in 250 participants. Completed in 31 December 2021.

Timeline

7 February 2020

Primary endpoint
31 October 2021

31 December 2021

Quick facts

Lead sponsor	Human Development Research Foundation, Pakistan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	250
Start date	7 February 2020
Primary completion	31 October 2021
Estimated completion	31 December 2021
Sites	1 location across Pakistan

Drugs / interventions tested

• Intervention arm
• Treatment as Usual

Conditions studied

• Maternal Distress — all drugs for Maternal Distress →
• Perinatal Depression — all drugs for Perinatal Depression →
• Development Delay — all drugs for Development Delay →
• Language Delay — all drugs for Language Delay →

Sponsor

Human Development Research Foundation, Pakistan

Who can join

Adults 18 to 40, female only, with Maternal Distress or Perinatal Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Millions of children in low resource settings are at high risk of poor development due to factors such as undernutrition, inadequate stimulation and maternal depression. Evidence based interventions to address these risk factors exist, but often as a separate and overlapping packages delivered through disjointed systems, therefore posing problems in scale-up. A common elements approach based intervention that combines evidence-based elements from packages of care addressing early stimulation, responsive feeding and maternal distress have been developed.

Objectives: The current study aims to develop an online training curriculum to train lay health workers in common elements based intervention to improve maternal psychological well-being and improve mother-infant interaction among distressed mothers in low resource rural community settings of Pakistan. The impact of intervention on maternal well-being, infant growth, nutrition and development will be evaluated at 12-months post-partum.

Method: A two arm, single blind, individual randomized controlled trial (RCT) will be carried out in the community settings of the rural sub-district of Gujar Khan in Rawalpindi, Pakistan. 250 Pregnant women in third trimester of pregnancy, screened positive for psychological distress on Self-Reporting Questionnaire (SRQ), cut-off score ≥ 9, will be randomized on 1:1 allocation ratio into intervention (n=125) and Treatment as Usual (TAU) arms (n=125). The participants in the intervention arm will receive 15 monthly sessions of intervention by community volunteers at home. First three sessions will be delivered in the third trimester of pregnancy followed by one monthly session for 12 months. The primary outcome will be caregiver-infant interaction at 12-months post-partum. The maternal secondary outcomes include maternal psychological wellbeing, quality of life, social support and empowerment. Maternal outcomes will be measured at baseline, 6-months and 12-months post-partum. Infant secondary outcomes include growth, nutrition and development and will be measured at 12 months. A mixed-methods process monitoring and evaluation will be conducted to inform the feasibility of intervention delivery.

Discussion: The outcomes of the study will be a common-elements based online training curriculum for training of community volunteers in intervention to improve maternal psychological well-being and mother-infant interaction in low resource rural community settings at-scale.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Primary-level and community worker interventions for the prevention of mental disorders and the promotion of well-being in low- and middle-income countries.
   Purgato M, Prina E, Ceccarelli C, Cadorin C, et al · · 2023 · cited 17× · PMID 37873968 · DOI 10.1002/14651858.cd014722.pub2
2. Evaluating the impact of a common elements-based intervention to improve maternal psychological well-being and mother-infant interaction in rural Pakistan: study protocol for a randomised controlled trial.
   Huma ZE, Gillani A, Shafique F, Rashid A, et al · · 2021 · cited 2× · PMID 34233989 · DOI 10.1136/bmjopen-2020-047609
3. Breastfeeding interventions for preventing postpartum depression.
   Lenells M, Uphoff E, Marshall D, Wilson E, et al · · 2025 · cited 1× · PMID 39963955 · DOI 10.1002/14651858.cd014833.pub2