Clinical trial NCT04252807: A Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction
Official title: Evaluating the Impact of a Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction in a Low Resource Community Setting of Rural Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Distress
Perinatal Depression
Development Delay
Language Delay
Cognitive Developmental Delay
Nutrition Poor
Growth Delay
Motor Delay
Maternal Behavior
Infant Development
Infant Malnutrition
Infant Behavior
Lead sponsor: Human Development Research Foundation, Pakistan
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: University of Liverpool
name: WHO Collaborating Center for mental health research, Institute of Psychiatry, Rawalpindi, Pakistan
First posted: 2020-02-05
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind, two arm, individual randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Observation of Mother and Child Interaction Tool (OMCI)
timeFrame: At 12-months postpartum
Secondary outcomes:
measure: Bayley's Scales of Infant Development (BSID III)
timeFrame: At 12-months postpartum
measure: Ages and Stages Questionnaire 3rd Edition (ASQ3)
timeFrame: At 12-months postpartum
measure: The Home Observation for Measurement of the Environment Scale (HOME)
timeFrame: At 12-months postpartum
measure: Anthropometric measurements
timeFrame: At 12-months postpartum
measure: Early breastfeeding (EBF) scale
timeFrame: At 6-months postpartum
measure: Number of diarrhoeal episodes
timeFrame: At 6 and 12-months postpartum
measure: Immunization record form
timeFrame: At 6 and 12-months postpartum
measure: Self-Reporting Questionnaire (SRQ)
timeFrame: At baseline, 6 and 12-months postpartum
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: At baseline and 12-months postpartum
measure: Multi-Dimensional Scale of Perceived Social Support (MSPSS)
timeFrame: At baseline and 12-months postpartum
measure: World Health Organization Disability Assessment Schedule (WHODAS-12)
timeFrame: At baseline and 12-months' post-partum
measure: Maternal Financial Empowerment Scale
timeFrame: At baseline and 12-months' post-partum
measure: Client Service Receipt Inventory (CSRI)
timeFrame: At baseline and 12-months postpartum
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Human Development Research Foundation
Study officials:
affiliation: Human Development Research Foundation, Pakistan
name: Syed Usman Hamdani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasheed MA, Yousafzai AK. The development and reliability of an observational tool for assessing mother-child interactions in field studies- experience from Pakistan. Child Care Health Dev. 2015 Nov;41(6):1161-71. doi: 10.1111/cch.12287. Epub 2015 Sep 9.
citation: Albers CA, Grieve AJ. Test review: Bayley, N.(2006). Bayley scales of infant and toddler development-third edition. San Antonio, TX: Harcourt assessment. Journal of Psychoeducational Assessment. 2007;25(2):180-90.
citation: Squires J, Bricker DD, Twombly E. Ages & stages questionnaires: Paul H. Brookes Baltimore, MD; 2009.
citation: Caldwell BM, Bradley RH. Home observation for measurement of the environment: University of Arkansas at Little Rock Little Rock; 1984
citation: Committee WE. Physical status: the use and interpretation of anthropometry. http://helid digicollection Org/en/d/Jh0211e/. 1995.
citation: Sikander S, Maselko J, Zafar S, Haq Z, Ahmad I, Ahmad M, Hafeez A, Rahman A. Cognitive-behavioral counseling for exclusive breastfeeding in rural pediatrics: a cluster RCT. Pediatrics. 2015 Feb;135(2):e424-31. doi: 10.1542/peds.2014-1628. Epub 2015 Jan 12.
citation: Beusenberg M, Orley JH, Organization WH. A User's guide to the self reporting questionnaire (SRQ. Geneva: World Health Organization; 1994.
citation: Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.
citation: Zimet GD, Dahlem NW, Zimet SG, Farley GKJJopa. The multidimensional scale of perceived social support. 1988;52(1):30-41.
citation: Üstün TB, Kostanjsek N, Chatterji S, Rehm J. Measuring health and disability: Manual for WHO disability assessment schedule WHODAS 2.0: World Health Organization; 2010.
citation: Rahman A, Sikander S, Malik A, Ahmed I, Tomenson B, Creed F. Effective treatment of perinatal depression for women in debt and lacking financial empowerment in a low-income country. Br J Psychiatry. 2012 Dec;201(6):451-7. doi: 10.1192/bjp.bp.112.109207. Epub 2012 Nov 8.
citation: Huma ZE, Gillani A, Shafique F, Rashid A, Mahjabeen B, Javed H, Wang D, Rahman A, Hamdani SU. 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. BMJ Open. 2021 Jul 7;11(7):e047609. doi: 10.1136/bmjopen-2020-047609.