Family Planning ServicesMARIANCT07659509
Mental and Reproductive Health Integration and Access
A study testing MARIA Integrated Maternal Mental Health and Family Planning Package in people with Family Planning Services and Post Partum Depression, run by Eastern Mediterranean Public Health Network at 2 sites in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Family Planning Services, Post Partum Depression
- What is being tested?
- MARIA Integrated Maternal Mental Health and Family Planning Package
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 920 participants
- Where
- 2 sitesJordan
- Study dates
- Sep 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- Unmarried women
- Unable to provide informed consent
- Planning to leave the study area within 7 months
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Abu Khudair contact
Jordan2 sites
Alkhaldieh
Al Mafraq, 11181
Randa Saad, 962781665060, rsaad@emphnet.net
Alsheikh Hussein
Irbid, Amman Governorate, 11181
Randa Saad, 962781665060, rsaad@emphnet.net
About this study
Official title: 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:
- Does the MARIA intervention increase the use of modern contraceptive methods among postnatal women compared to standard care?
- Does the MARIA intervention reduce the prevalence and severity of postpartum depression symptoms compared to standard care?
Read more
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
- Conditions
- Family Planning Services, Post Partum Depression
- Being tested
- MARIA Integrated Maternal Mental Health and Family Planning Package
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARIA Integrated Maternal Mental Health and Family Planning PackageBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants adopting any modern contraceptive method since baseline
Measured: from baseline until 7 months
Secondary outcomes (7)
number of women with postpartum depression
Edinburgh Postnatal Depression Scale
Measured: from baseline until 7 months
number of women who continue the modern contraception
Measured: 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
Measured: at 7 months
change in baseline in the number of women with positive attitude towards pregnancy
Attitude Toward Potential Pregnancy Scale (APPS)
Measured: at 7 months
number of women with improved knowledge of family planning since baseline
Measured: at 7 months
improved couple communication since baseline
Measured: at 7 months
improved provider capacity in family planning and mental health services
Measured: at 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Planning ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean Public Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659509
- Sponsor's protocol ID
- 110529 - 001
- Acronym
- MARIA
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Family Planning and Mental Health Services Into Postnatal Care for Migrant, Refugee, and Underserved Jordanian Women
- ClinicalTrials.gov ID
- NCT07659509
- Acronym / sponsor ID
- MARIA / 110529 - 001
- Conditions
- Family Planning Services, Post Partum Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 920 participants (estimated)
- Lead sponsor
- Eastern Mediterranean Public Health NetworkUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the MARIA intervention increase the use of modern contraceptive methods among postnatal women compared to standard care?
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MARIA Integrated Family Planning and Mental Health Intervention | Experimental | Behavioral: MARIA Integrated Maternal Mental Health and Family Planning PackagePrimary 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. |
| 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MARIA Integrated Maternal Mental Health and Family Planning PackageA 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 | Behavioural | MARIA Integrated Family Planning and Mental Health Intervention |
Primary outcome
Number of Participants adopting any modern contraceptive method since baseline
Time frame: from baseline until 7 months
7 secondary outcomes
number of women with postpartum depression
Time frame: from baseline until 7 months
number of women who continue the modern contraception
Time frame: at the end of the 7 months follow up
change in baseline in the number of women who feel empowered
Time frame: at 7 months
change in baseline in the number of women with positive attitude towards pregnancy
Time frame: at 7 months
number of women with improved knowledge of family planning since baseline
Time frame: at 7 months
improved couple communication since baseline
Time frame: at 7 months
improved provider capacity in family planning and mental health services
Time frame: at 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Abu Khudair contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MARIA Integrated Maternal Mental Health and Family Planning Package in people with Family Planning Services and Post Partum Depression, run by Eastern Mediterranean Public Health Network at 2 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randa K. Saad, MD (+962781665060, rsaad@emphnet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants adopting any modern contraceptive method since baseline (time frame: from baseline until 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.