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

NCT04252807 | Completed DMC

• 1 other identifier: GCC definitive cRCT
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Observation of Mother and Child Interaction Tool (OMCI)

  Maternal responsive caregiving behaviours will be assessed using the Observation of Mother and Child Interaction (OMCI) tool . OMCI tool is based on responsive parenting framework proposed by Landry and colleagues. The research assistants will observe a live 5-minute mother-infant interaction while mother and infant will play together with a picture book. The tool comprises of 19 items covering maternal affect, maternal touch, maternal verbalization, sensitivity and contingent responses, scaffolding, language stimulation, focus, child affect, child focus, child's communication efforts, and mutual enjoyment. The scoring format is based on the frequency of the occurrence of behaviours with higher scores indicating more responsive interactions. The OMCI tool has been validated for use in similar population in Pakistan.

  At 12-months postpartum

Secondary Outcomes (13)

• Bayley's Scales of Infant Development (BSID III)

  At 12-months postpartum

• Ages and Stages Questionnaire 3rd Edition (ASQ3)

  At 12-months postpartum

• The Home Observation for Measurement of the Environment Scale (HOME)

  At 12-months postpartum

• Anthropometric measurements

  At 12-months postpartum

• Early breastfeeding (EBF) scale

  At 6-months postpartum

Study Arms (2)

Intervention arm

EXPERIMENTAL

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.

Behavioral: Intervention arm

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Other: Treatment as Usual

Interventions

Intervention arm BEHAVIORAL

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.

Intervention arm

Treatment as Usual OTHER

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female participants
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Human Development Research Foundation, Pakistan: lead
• World Health Organization: collaborator
• University of Liverpool: collaborator
• Benazir Bhutto Hospital, Rawalpindi: collaborator

Study Sites (1)

Human Development Research Foundation

Islamabad, Pakistan

Location

Related Publications (12)

• 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.

  PMID: 26350208 BACKGROUND

• 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.

  BACKGROUND

• Squires J, Bricker DD, Twombly E. Ages & stages questionnaires: Paul H. Brookes Baltimore, MD; 2009.

  BACKGROUND

• Caldwell BM, Bradley RH. Home observation for measurement of the environment: University of Arkansas at Little Rock Little Rock; 1984

  BACKGROUND

• Committee WE. Physical status: the use and interpretation of anthropometry. http://helid digicollection Org/en/d/Jh0211e/. 1995.

  BACKGROUND

• 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.

  PMID: 25583916 BACKGROUND

• Beusenberg M, Orley JH, Organization WH. A User's guide to the self reporting questionnaire (SRQ. Geneva: World Health Organization; 1994.

  BACKGROUND

• 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.

  PMID: 10024117 BACKGROUND

• Zimet GD, Dahlem NW, Zimet SG, Farley GKJJopa. The multidimensional scale of perceived social support. 1988;52(1):30-41.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23137731 BACKGROUND

• 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.

  PMID: 34233989 DERIVED

MeSH Terms

Conditions

Learning Disabilities; Language Development Disorders; Malnutrition; Psychomotor Disorders; Infant Nutrition Disorders; Infant Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Language Disorders; Nutrition Disorders; Nutritional and Metabolic Diseases; Child Behavior; Behavior

Study Officials

• Syed Usman Hamdani, PhD

  Human Development Research Foundation, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study investigators and outcome assessors will be blind to the allocations status of participants. To ensure blinding, participants will be instructed to not disclose their allocation during assessment. Fidelity of masking will be ensured by having assessors guess the allocation status of participants at the end of assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind, two arm, individual randomized controlled trial

Study Record Dates

• First Submitted: September 14, 2019
• First Posted: February 5, 2020
• Study Start: February 7, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available beginning 9 months and ending 36 months following article publication.
• Access Criteria: The data will be shared with investigators who provide a methodologically sound proposal and state that data will be used for purpose of individual participant data meta-analysis only. The research proposals should be directed to syedusmanhamdani@gmail.com to gain access of the data. The data requestors will need to sign a data access agreement as well.

Locations

PA (1)