Mental and Reproductive Health Integration and Access

NCT07659509 | Not Yet Recruiting

• 1 other identifier: 110529 - 001
• Study Type: interventional
• Target: 920
• Locations: 1 country
• Sites: 2

Brief Summary

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:

• 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

Conditions

Family Planning Services; Post Partum Depression

Outcome Measures

Primary Outcomes (1)

• Number of Participants adopting any modern contraceptive method since baseline

  from baseline until 7 months

Secondary Outcomes (7)

• number of women with postpartum depression

  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

  at 7 months

• change in baseline in the number of women with positive attitude towards pregnancy

  at 7 months

• number of women with improved knowledge of family planning since baseline

  at 7 months

Study Arms (2)

MARIA Integrated Family Planning and Mental Health Intervention

EXPERIMENTAL

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

Standard Care (Control)

NO INTERVENTION

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.

Interventions

MARIA Integrated Maternal Mental Health and Family Planning Package BEHAVIORAL

A multi-component integrated package delivered within routine postnatal and immunization visits at primary healthcare centers. Has 7 components 1. 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. 2. Community health workers community outreach 3. Provider training 4. Supportive Supervision 5. Communication/educational material (brochures, pamphlets, videos in waiting area) 6. A project website and automated electronic Edinburgh Postnatal Depression Scale tool accessible via QR code for use by providers, community health workers, and women 7. online learning courses on implementation research and leadership and management

MARIA Integrated Family Planning and Mental Health Intervention

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Currently using a modern contraceptive method
• Unmarried women
• Unable to provide informed consent
• Planning to leave the study area within 7 months

Sponsors & Collaborators

• Eastern Mediterranean Public Health Network: lead

Study Sites (2)

Alsheikh Hussein

Irbid, Amman Governorate, 11181, Jordan

Location

Alkhaldieh

Al Mafraq, 11181, Jordan

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Randa K. Saad, MD

CONTACT

+962781665060; rsaad@emphnet.net

Sara Abu Khudair

CONTACT

sabukhudair@emphnet.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (2)