A Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction
NCT ID: NCT04252807
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2020-02-07
2021-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Fidelity of masking will be ensured by having assessors guess the allocation status of participants at the end of assessments.
Study Groups
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Intervention arm
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.
Intervention arm
In addition to the routine care delivered by Lady Health Workers (LHWs), the participants in the intervention arm will receive common elements based integrated intervention. The providers of the intervention are lay health workers who will be trained in the intervention using an online course. The lay health worker will complete the online training course in a group, with interactive group activities and role plays. Lay health workers will be supported online and in-person by the trainers in monthly supervision meetings. The lay health workers will deliver intervention to distressed mothers in 15 monthly sessions. The intervention consists of three modules including 1) mothers' well-being, 2) infant nutrition,early stimulation and breastfeeding and 3) mother-infant interaction.
Treatment as Usual (TAU)
The participants in the control arm will receive the routine monthly visits by the trained Lady Health Workers (LHWs) of their respective areas.
Treatment as Usual
The participants in the control arm will receive the routine visits by LHWs of their respective areas. The LHWs are trained to provide antenatal care and referral, immunization services and support to community mobilization, provision of family planning and basic curative care via door to door visits to the households of their allocated areas.
Interventions
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Intervention arm
In addition to the routine care delivered by Lady Health Workers (LHWs), the participants in the intervention arm will receive common elements based integrated intervention. The providers of the intervention are lay health workers who will be trained in the intervention using an online course. The lay health worker will complete the online training course in a group, with interactive group activities and role plays. Lay health workers will be supported online and in-person by the trainers in monthly supervision meetings. The lay health workers will deliver intervention to distressed mothers in 15 monthly sessions. The intervention consists of three modules including 1) mothers' well-being, 2) infant nutrition,early stimulation and breastfeeding and 3) mother-infant interaction.
Treatment as Usual
The participants in the control arm will receive the routine visits by LHWs of their respective areas. The LHWs are trained to provide antenatal care and referral, immunization services and support to community mobilization, provision of family planning and basic curative care via door to door visits to the households of their allocated areas.
Eligibility Criteria
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Inclusion Criteria
* Age 18-40 years
* Intent to reside in the study areas until the completion of the study
* Score ≥9 on the SRQ
Exclusion Criteria
* Severe previous or current obstetric morbidity including eclampsia and antepartum hemorrhage;
* Medical disorders that require inpatient management (e.g., diabetes, hypertension, thromboembolism, cardiac disease)
18 Years
40 Years
FEMALE
No
Sponsors
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World Health Organization
OTHER
University of Liverpool
OTHER
WHO Collaborating Center for mental health research, Institute of Psychiatry, Rawalpindi, Pakistan
UNKNOWN
Human Development Research Foundation, Pakistan
OTHER
Responsible Party
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Principal Investigators
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Syed Usman Hamdani, PhD
Role: PRINCIPAL_INVESTIGATOR
Human Development Research Foundation, Pakistan
Locations
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Human Development Research Foundation
Islamabad, , Pakistan
Countries
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References
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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.
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.
Squires J, Bricker DD, Twombly E. Ages & stages questionnaires: Paul H. Brookes Baltimore, MD; 2009.
Caldwell BM, Bradley RH. Home observation for measurement of the environment: University of Arkansas at Little Rock Little Rock; 1984
Committee WE. Physical status: the use and interpretation of anthropometry. http://helid digicollection Org/en/d/Jh0211e/. 1995.
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.
Beusenberg M, Orley JH, Organization WH. A User's guide to the self reporting questionnaire (SRQ. Geneva: World Health Organization; 1994.
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.
Zimet GD, Dahlem NW, Zimet SG, Farley GKJJopa. The multidimensional scale of perceived social support. 1988;52(1):30-41.
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.
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.
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.
Other Identifiers
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GCC definitive cRCT
Identifier Type: -
Identifier Source: org_study_id
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