Mental and Reproductive Health Integration and Access (MARIA)

Integrating Family Planning and Mental Health Services Into Postnatal Care for Migrant, Refugee, and Underserved Jordanian Women

The goal of this clinical trial is to learn whether an integrated package of mental health screening, brief psychosocial support, and family planning counseling delivered within routine postnatal care can improve reproductive and mental health outcomes in postpartum migrant, refugee, and underserved Jordanian women aged 15-49 attending primary health centers in Mafraq Governorate and the Al-Ghour region of Jordan. The main questions it aims to answer are:

1. Does the MARIA intervention increase the use of modern contraceptive methods among postnatal women compared to standard care?
2. Does the MARIA intervention reduce the prevalence and severity of postpartum depression symptoms compared to standard care?

Researchers will compare women attending health centers that deliver the full MARIA package (integrated mental health screening, brief psychosocial support, and family planning counseling) to women attending health centers that provide standard care (routine immunization and child health services without the MARIA components) to see if the intervention improves contraceptive use and reduces postpartum depression.

Participants will:

• Complete a 10-question mental health screening tool (Edinburgh Postnatal Depression Scale) at their routine immunization visit
• Receive a brief educational session, psychosocial support, or a referral to specialist mental health services - depending on their screening result
• Receive family planning counseling and information about contraceptive options during the same visit
• Be followed up by a community health worker, as needed
• Participate in three interviews - one in person at enrollment and two by telephone at 4 and 7 months after joining

Study Overview

• Status: Not yet recruiting
• Conditions: Post Partum Depression; Family Planning Services
• Intervention / Treatment: Behavioral: MARIA Integrated Maternal Mental Health and Family Planning Package

• Study Type: Interventional
• Enrollment (Estimated): 920
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Randa K. Saad, MD; Phone Number: +962781665060; Email: rsaad@emphnet.net
• Study Contact Backup: Name: Sara Abu Khudair; Email: sabukhudair@emphnet.net

Study Locations

• Jordan
  • Al Mafraq, Jordan, 11181
    • Alkhaldieh
    • Contact: Randa Saad; Phone Number: 962781665060; Email: rsaad@emphnet.net
  • Amman Governorate
    • Irbid, Amman Governorate, Jordan, 11181
      • Alsheikh Hussein
      • Contact: Randa Saad; Phone Number: 962781665060; Email: rsaad@emphnet.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Postpartum women aged 15-49 years
• Attending selected primary healthcare centers for infant immunization or healthy child visits
• Unmet family planning need: interested in using contraception but currently not doing so
• Living in study villages (Mafraq or Al-Ghour)
• Migrant, refugee, or underserved Jordanian women Exclusion Criteria
• Currently using a modern contraceptive method
• Unmarried women
• Unable to provide informed consent
• Planning to leave the study area within 7 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MARIA Integrated Family Planning and Mental Health Intervention; Primary healthcare centers randomized to the intervention arm, where the MARIA package is delivered: mental health screening using the Edinburgh Postnatal Depression Scale, stepped-care psychosocial support (Protocols P1-P4), integrated family planning counseling, community health worker follow-up, and supportive supervision of primary healthcare providers.	Behavioral: MARIA Integrated Maternal Mental Health and Family Planning Package; A multi-component integrated package delivered within routine postnatal and immunization visits at primary healthcare centers. Has 7 components; Integrated service delivery: All eligible postnatal women are screened for postpartum depression using Edinburgh Postnatal Depression Scale. Based on score, primary healthcare providers deliver stepped-care psychosocial support. Family planning counseling is integrated into the same visit for all women.; Community health workers community outreach; Provider training; Supportive Supervision; Communication/educational material (brochures, pamphlets, videos in waiting area); A project website and automated electronic Edinburgh Postnatal Depression Scale tool accessible via QR code for use by providers, community health workers, and women; online learning courses on implementation research and leadership and management
No Intervention: Standard Care (Control); Primary healthcare centers randomized to the control arm, where women receive routine primary health care services - standard immunization and child health visits - without any MARIA package components. No Edinburgh Postnatal Depression Scale screening, no structured psychosocial protocols, no MARIA provider training, and no community health worker outreach are delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants adopting any modern contraceptive method since baseline	from baseline until 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of women with postpartum depression	Edinburgh Postnatal Depression Scale	from baseline until 7 months
number of women who continue the modern contraception		at the end of the 7 months follow up
change in baseline in the number of women who feel empowered	Oxfam Women's Empowerment Measurement Tool	at 7 months
change in baseline in the number of women with positive attitude towards pregnancy	Attitude Toward Potential Pregnancy Scale (APPS)	at 7 months
number of women with improved knowledge of family planning since baseline		at 7 months
improved couple communication since baseline		at 7 months
improved provider capacity in family planning and mental health services		at 7 months

Collaborators and Investigators

• Sponsor: Eastern Mediterranean Public Health Network

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 110529 - 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No