ClinicalTrials.gg
Not yet recruitingNCT07659509MARIAUpdated Jun 22, 2026

Mental and Reproductive Health Integration and Access

An interventional study of MARIA Integrated Maternal Mental Health and Family Planning Package in Family Planning Services and Post Partum Depression, sponsored by Eastern Mediterranean Public Health Network. Not yet recruiting at 2 sites in Jordan. Open to female participants aged 15 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Eastern Mediterranean Public Health Network · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
920
Allocation
Randomized
Ages
15 Years to 49 Years
Sex
Female
01

Study 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:

  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
02

Conditions studied

  • Family Planning Services
  • Post Partum Depression
03

In context

Depression, Postpartum

569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.

This study's planned enrollment of 920 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

This is the only study on the registry with Eastern Mediterranean Public Health Network as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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 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
  • Planning to leave the study area within 7 months
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
920 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralMARIA 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 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

06

What researchers measure

Primary outcomes

  1. Number of Participants adopting any modern contraceptive method since baseline

    Time frame: from baseline until 7 months

Secondary outcomes

  1. number of women with postpartum depression

    Edinburgh Postnatal Depression Scale

    Time frame: from baseline until 7 months

  2. number of women who continue the modern contraception

    Time frame: at the end of the 7 months follow up

  3. change in baseline in the number of women who feel empowered

    Oxfam Women's Empowerment Measurement Tool

    Time frame: at 7 months

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

    Attitude Toward Potential Pregnancy Scale (APPS)

    Time frame: at 7 months

  5. number of women with improved knowledge of family planning since baseline

    Time frame: at 7 months

  6. improved couple communication since baseline

    Time frame: at 7 months

  7. improved provider capacity in family planning and mental health services

    Time frame: at 7 months

07

Study locations

2 sites
  • Alsheikh Hussein
    Irbid, Amman Governorate 11181, Jordan
  • Alkhaldieh
    Al Mafraq, 11181, Jordan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07659509
Lead sponsor
Eastern Mediterranean Public Health Network
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jun 22, 2026

Study contacts

Randa K. Saad, MD
Contact
rsaad@emphnet.net
+962781665060
Sara Abu Khudair
Contact
sabukhudair@emphnet.net

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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