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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252807
Recruitment Status : Active, not recruiting
First Posted : February 5, 2020
Last Update Posted : July 24, 2020
Sponsor:
Collaborators:
World Health Organization
University of Liverpool
WHO Collaborating Center for mental health research, Institute of Psychiatry, Rawalpindi, Pakistan
Information provided by (Responsible Party):
Human Development Research Foundation, Pakistan

Tracking Information
First Submitted Date  ICMJE September 14, 2019
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date July 24, 2020
Actual Study Start Date  ICMJE February 7, 2020
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
Observation of Mother and Child Interaction Tool (OMCI) [ Time Frame: At 12-months postpartum ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
  • Bayley's Scales of Infant Development (BSID III) [ Time Frame: At 12-months postpartum ]
    Bayley's Scales of Infant Development (BSID III) will be used to measure cognitive, language, motor, socio-emotional development and adaptive behaviours. Each item is rated on 0 or 1. Higher scores indicate better development and functioning.
  • Ages and Stages Questionnaire 3rd Edition (ASQ3) [ Time Frame: At 12-months postpartum ]
    Ages and Stages Questionnaire 3rd Edition (ASQ3) will be used to measure developmental delays in communication, gross motor, fine motor, problem solving, and personal social domains. It provides cut-off score in 5 domains of development that indicates possible need for further evaluation. It highlights results that fall in a "monitoring zone," to make it easier to keep track of children at risk. Items are rated on 3-point likert scale, yes (10), sometime (5) and not yet (0). Higher score indicates that child is developing well.
  • The Home Observation for Measurement of the Environment Scale (HOME) [ Time Frame: At 12-months postpartum ]
    Quality and quantity of stimulation and support in the child's home will be measured using home inventory. It has 45 items, rated on dichotomous scale, yes (1) or no (0). It has six sub-scales including parental responsiveness, acceptance of child, organization of environment, learning materials, parental involvement, variety in experience. Higher score shows more enriched home environment.
  • Anthropometric measurements [ Time Frame: At 12-months postpartum ]
    Infants in both groups will be weighed and measured with standard techniques. Growth data will be converted into SDs (Z scores) for weight and length with Epi Info 2002 (version 3.4.1).
  • Early breastfeeding (EBF) scale [ Time Frame: At 6-months postpartum ]
    Assessors will document what the infant was fed in the last 24 hours at 6 months postpartum. This information will be categorized as either EBF, partial breastfeeding (giving an infant some breastfeeding, and some artificial foods, either milk, cereal, or other food items), or no breastfeeding, using three items scale. The items will be rated on 3-point likert scale; yes (1), no (0) and don't know (888). Lower score represents that infant is not exclusively breastfed. If the infant will not exclusively breastfeed, details of when (age of infant) and why EBF was discontinued will be recorded. At the first follow-up immediately after delivery, details about early initiation, discarding colostrum, use of pre-lacteals, and reasons for delaying or not initiating breastfeeding will be assessed۔
  • Number of diarrhoeal episodes [ Time Frame: At 6 and 12-months postpartum ]
    The number of diarrhoeal episodes in the infants during the 2 weeks before interview will be recorded at 6 and 12 months post-partum, with a questionnaire used in previous studies. Diarrhoea will be defined as three or more unformed stools passed in 24 h, and a diarrhoeal episode will be defined as being separated from another episode by at least 3 diarrhoea-free days.
  • Immunization record form [ Time Frame: At 6 and 12-months postpartum ]
    Records of immunization will be assessed for all infants in the study, and infants will be classified as those with or without up-to-date immunisation status 6 and 12 months postpartum.
  • Self-Reporting Questionnaire (SRQ) [ Time Frame: At baseline, 6 and 12-months postpartum ]
    Maternal distress will be measured by the Self Reporting Questionnaire (SRQ). SRQ is a 20-item self-report measure to detect non-specific psychological distress, developed by the World Health Organization. The SRQ items are scored 0 or 1. A score of 1 indicates the presence of symptoms of psychological distress during past month and a score of 0 indicates absence of symptoms. The maximum score indicates presence of higher psychological distress.
  • Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: At baseline and 12-months postpartum ]
    Caregivers' health related quality of life will be measured by Paediatric Quality of Life Inventory (PedsQL) family impact module. The PedsQL is 36 item impact module scale that encompasses 6 sub-scales measuring parent self-reported functioning. These subscales measure physical functioning, emotional functioning, social functioning, daily activities and family relationships. Items are rated on a 5-point Likert scale (0 = never to 4 = almost always). Higher scores indicate better functioning
  • Multi-Dimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: At baseline and 12-months postpartum ]
    The level of social support will be measured using Multi-Dimensional Scale of Perceived Social Support (MSPSS). It includes 12 items which cover three dimensions: support from family, friends and significant other. Each item is rated on a 7-point Likert-scale (1 = very strongly disagree; 7 = very strongly agree). A total score is calculated by summing the responses of all items (range 12-84) with higher scores indicating higher levels of perceived social support.
  • World Health Organization Disability Assessment Schedule (WHODAS-12) [ Time Frame: At baseline and 12-months' post-partum ]
    Caregiver's level of functioning will be measured using World Health Organization Disability Assessment Schedule (WHODAS-12). WHODAS assesses participants' health-related difficulties in the level of functioning in six domains of life (understanding and communicating; moving and getting around; attending to one's hygiene, dressing, eating and staying alone; interacting with other people; domestic responsibilities, leisure, work and school and joining in community activities, participating in society) over the past 30 days. It has 12 items rated on 5-point likert scale, 1 to 5. High score represents more disability/ impaired functioning.
  • Maternal Financial Empowerment Scale [ Time Frame: At baseline and 12-months' post-partum ]
    Women's empowerment will be measured using a questionnaire consisting of: (a) two items previously used in the same population that assess financial empowerment (i.e., whether a woman is given a lump-sum of money for day-to-day expenses and whether she can make independent decisions about its use) and (b) 7 items to measure relative freedom from domination within the family (i.e., whether in the past year family had taken money, land, jewellery or livestock from her against her will, prevented her from visiting her parental home, or prevented her from working outside the home) and economic security and contribution (i.e., does she possess any land, productive assets, and or cash). Women who answer 'yes' to both items on financial empowerment and three items from economic security and contribution subscales and 'no' to all items regarding family domination will be classified as 'empowered'.
  • Client Service Receipt Inventory (CSRI) [ Time Frame: At baseline and 12-months postpartum ]
    Utilization of health care will be measured by Client Service Receipt Inventory (CSRI) adapted for perinatal population of Pakistan. It measures participants' use of health and social care services, accommodation and living situation, family income and social benefits. The data collected through the CSRI can be used to calculate service costs and total costs of care for each research participant.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • Bayley's Scales of Infant Development (BSID III) [ Time Frame: At 6 and 12-months postpartum ]
    Bayley's Scales of Infant Development (BSID III) will be used to measure cognitive, language, motor, socio-emotional development and adaptive behaviours. Each item is rated on 0 or 1. Higher scores indicate better development and functioning.
  • Ages and Stages Questionnaire 3rd Edition (ASQ3) [ Time Frame: 6 and 12-months postpartum ]
    Ages and Stages Questionnaire 3rd Edition (ASQ3) will be used to measure developmental delays in communication, gross motor, fine motor, problem solving, and personal social domains. It provides cut-off score in 5 domains of development that indicates possible need for further evaluation. It highlights results that fall in a "monitoring zone," to make it easier to keep track of children at risk. Items are rated on 3-point likert scale, yes (10), sometime (5) and not yet (0). Higher score indicates that child is developing well.
  • The Home Observation for Measurement of the Environment Scale (HOME) [ Time Frame: At 6 and 12-months postpartum ]
    Quality and quantity of stimulation and support in the child's home will be measured using home inventory. It has 45 items, rated on dichotomous scale, yes (1) or no (0). It has six sub-scales including parental responsiveness, acceptance of child, organization of environment, learning materials, parental involvement, variety in experience. Higher score shows more enriched home environment.
  • Anthropometric measurements [ Time Frame: At 6 and 12-months postpartum ]
    Infants in both groups will be weighed and measured with standard techniques. Growth data will be converted into SDs (Z scores) for weight and length with Epi Info 2002 (version 3.4.1).
  • Early breastfeeding (EBF) scale [ Time Frame: At 6-months postpartum ]
    Assessors will document what the infant was fed in the last 24 hours at 6 months postpartum. This information will be categorized as either EBF, partial breastfeeding (giving an infant some breastfeeding, and some artificial foods, either milk, cereal, or other food items), or no breastfeeding, using three items scale. The items will be rated on 3-point likert scale; yes (1), no (0) and don't know (888). Lower score represents that infant is not exclusively breastfed. If the infant will not exclusively breastfeed, details of when (age of infant) and why EBF was discontinued will be recorded. At the first follow-up immediately after delivery, details about early initiation, discarding colostrum, use of pre-lacteals, and reasons for delaying or not initiating breastfeeding will be assessed۔
  • Number of diarrhoeal episodes [ Time Frame: At 6 and 12-months postpartum ]
    The number of diarrhoeal episodes in the infants during the 2 weeks before interview will be recorded at 6 and 12 months post-partum, with a questionnaire used in previous studies. Diarrhoea will be defined as three or more unformed stools passed in 24 h, and a diarrhoeal episode will be defined as being separated from another episode by at least 3 diarrhoea-free days.
  • Immunization record form [ Time Frame: At 6 and 12-months postpartum ]
    Records of immunization will be assessed for all infants in the study, and infants will be classified as those with or without up-to-date immunisation status 6 and 12 months postpartum.
  • Self-Reporting Questionnaire (SRQ) [ Time Frame: At baseline, immediate post-intervention, 3, 6 and 12-months postpartum ]
    Maternal distress will be measured by the Self Reporting Questionnaire (SRQ). SRQ is a 20-item self-report measure to detect non-specific psychological distress, developed by the World Health Organization. The SRQ items are scored 0 or 1. A score of 1 indicates the presence of symptoms of psychological distress during past month and a score of 0 indicates absence of symptoms. The maximum score indicates presence of higher psychological distress.
  • Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: At 6 and 12-months postpartum ]
    Caregivers' health related quality of life will be measured by Paediatric Quality of Life Inventory (PedsQL) family impact module. The PedsQL is 36 item impact module scale that encompasses 6 sub-scales measuring parent self-reported functioning. These subscales measure physical functioning, emotional functioning, social functioning, daily activities and family relationships. Items are rated on a 5-point Likert scale (0 = never to 4 = almost always). Higher scores indicate better functioning
  • Multi-Dimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: At baseline and 12-months postpartum ]
    The level of social support will be measured using Multi-Dimensional Scale of Perceived Social Support (MSPSS). It includes 12 items which cover three dimensions: support from family, friends and significant other. Each item is rated on a 7-point Likert-scale (1 = very strongly disagree; 7 = very strongly agree). A total score is calculated by summing the responses of all items (range 12-84) with higher scores indicating higher levels of perceived social support.
  • World Health Organization Disability Assessment Schedule (WHODAS-12) [ Time Frame: At baseline and 12-months' post-partum ]
    Caregiver's level of functioning will be measured using World Health Organization Disability Assessment Schedule (WHODAS-12). WHODAS assesses participants' health-related difficulties in the level of functioning in six domains of life (understanding and communicating; moving and getting around; attending to one's hygiene, dressing, eating and staying alone; interacting with other people; domestic responsibilities, leisure, work and school and joining in community activities, participating in society) over the past 30 days. It has 12 items rated on 5-point likert scale, 1 to 5. High score represents more disability/ impaired functioning.
  • Maternal Financial Empowerment Scale [ Time Frame: At baseline and 12-months' post-partum ]
    Women's empowerment will be measured using a questionnaire consisting of: (a) two items previously used in the same population that assess financial empowerment (i.e., whether a woman is given a lump-sum of money for day-to-day expenses and whether she can make independent decisions about its use) and (b) 7 items to measure relative freedom from domination within the family (i.e., whether in the past year family had taken money, land, jewellery or livestock from her against her will, prevented her from visiting her parental home, or prevented her from working outside the home) and economic security and contribution (i.e., does she possess any land, productive assets, and or cash). Women who answer 'yes' to both items on financial empowerment and three items from economic security and contribution subscales and 'no' to all items regarding family domination will be classified as 'empowered'.
  • Client Service Receipt Inventory (CSRI) [ Time Frame: At baseline and 12-months postpartum ]
    Utilization of health care will be measured by Client Service Receipt Inventory (CSRI) adapted for perinatal population of Pakistan. It measures participants' use of health and social care services, accommodation and living situation, family income and social benefits. The data collected through the CSRI can be used to calculate service costs and total costs of care for each research participant.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single blind, two arm, individual randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Behavioral: 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.
  • Other: 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.
Study Arms  ICMJE
  • Experimental: 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: Behavioral: Intervention arm
  • Active Comparator: 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.
    Intervention: Other: Treatment as Usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 31, 2020)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female participants
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04252807
Other Study ID Numbers  ICMJE GCC definitive cRCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Human Development Research Foundation, Pakistan
Study Sponsor  ICMJE Human Development Research Foundation, Pakistan
Collaborators  ICMJE
  • World Health Organization
  • University of Liverpool
  • WHO Collaborating Center for mental health research, Institute of Psychiatry, Rawalpindi, Pakistan
Investigators  ICMJE
Principal Investigator: Syed Usman Hamdani, PhD Human Development Research Foundation, Pakistan
PRS Account Human Development Research Foundation, Pakistan
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP