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

Human Development Research Foundation, Pakistan

Status: Completed

Conditions: Development Delay; Maternal Distress; Motor Delay; Infant Malnutrition; Perinatal Depression; Maternal Behavior; Infant Behavior; Infant Development; Growth Delay; Cognitive Developmental Delay; Nutrition Poor; Language Delay

Treatments: Other: Treatment as Usual; Behavioral: Intervention arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04252807

GCC definitive cRCT

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant with third trimester (28 gestational week)
• Age 18-40 years
• Intent to reside in the study areas until the completion of the study
• Score ≥9 on the SRQ

Exclusion criteria

• Women who require immediate or on-going medical or psychiatric care reported.
• Severe previous or current obstetric morbidity including eclampsia and antepartum hemorrhage;
• Medical disorders that require inpatient management (e.g., diabetes, hypertension, thromboembolism, cardiac disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Distressed mothers randomized to intervention arm will receive a common elements based integrated intervention that combines evidence based elements from packages of care addressing early stimulation, responsive feeding and perinatal depression. The integrated intervention is expected to a) improve mother psychological distress, b) improve family support, c) improve child development and d) promote mother-infant interaction. The participants will receive 15 monthly sessions at home by lay health workers. First three sessions will be delivered to the participants in the third trimester of pregnancy, followed by 12 monthly sessions afterwards.

Treatment:

Behavioral: Intervention arm

Treatment as Usual (TAU)

Active Comparator group

Description:

The participants in the control arm will receive the routine monthly visits by the trained Lady Health Workers (LHWs) of their respective areas.

Treatment:

Other: Treatment as Usual