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Supporting women's role integration and identity during the emotional transition to motherhood

I-MATERNA: Identity and Maternal Adjustment for the Emotional Transition and Role integration in New Adulthood. Study protocol for a multicenter randomized controlled trial in pregnant women, comparing a psychosocial intervention with standard care to improve role integration, identity consolidation and emotional wellbeing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16642296
Enrollment
78
Registered
2025-12-10
Start date
2025-01-19
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and motherhood Pregnancy and Childbirth

Interventions

We invite the training group to participate in the I-Materna program that we have specially designed for pregnancy, to prevent psychological symptoms and promote psychological well-being through the i

Sponsors

Universidad Rey Juan Carlos
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18 years or older 2. Sufficient spoken and written comprehension of Spanish 3. Pregnancy without physiological complications that may compromise fetal development 4. No prior diagnosis of maternal psychological disorders before pregnancy 5. Voluntary acceptance of participation in the study 6. Inclusion in the intervention program between 10 and 14 weeks of gestation, at the first ultrasound medical visit

Exclusion criteria

Exclusion criteria: 1. Development of severe medical conditions during the study that may compromise the pregnancy 2. Current psychological treatment 3. Problematic substance use in the past 6 months 4. Participation in similar therapeutic programs in the past year 5. Withdrawal from the study after enrollment 6. Failure to attend at least 80 percent of the intervention sessions

Design outcomes

Primary

MeasureTime frame
Measured at (T1) during the initial session between gestational weeks 10 and 14, prior to intervention and group allocation; (T2) between gestational weeks 35 and 40; (T3) within the first week postpartum; and (T4) at five months postpartum: 1. Identity Scale (ad hoc). Developed by the research team 2. Maternal Role Integration Scale (ad hoc). Developed by the research team 3. Life satisfaction assessed using the Satisfaction with Life Scale (SWLS) (Diener, Emmons, Larsen, & Griffin, 1985)

Secondary

MeasureTime frame
1. Age is measured using an ad-hoc questionnaire at baseline (first trimester) 2. Gender is measured using an ad-hoc questionnaire at baseline (first trimester) 3. Country of origin is measured using an ad-hoc questionnaire at baseline (first trimester) 4. Educational level is measured using an ad-hoc questionnaire at baseline (first trimester) 5. Current employment status is measured using an ad-hoc questionnaire at baseline (first trimester) 6. Annual income is measured using an ad-hoc questionnaire at baseline (first trimester) 7. Marital status is measured using an ad-hoc questionnaire at baseline (first trimester) 8. History of previous abortions is measured using an ad-hoc questionnaire at baseline (first trimester) 9. Number of children previously delivered is measured using an ad-hoc questionnaire at baseline (first trimester) 10. Pregnancy planning status is measured using an ad-hoc questionnaire at baseline (first trimester) 11. Time taken to conceive is measured using an ad-hoc questionnaire at baseline (first trimester) 12. Parity status (primiparous or multiparous) is measured using an ad-hoc questionnaire at baseline (first trimester) 13. Biological origin of the baby is measured using an ad-hoc questionnaire at baseline (first trimester) 14. Current gestational week is measured using an ad-hoc questionnaire at baseline (first trimester) 15. Intention to breastfeed is measured using an ad-hoc questionnaire at baseline (first trimester) 16. Intended duration of breastfeeding in months is measured using an ad-hoc questionnaire at baseline (first trimester) 17. Gestational week at delivery is measured using an ad-hoc questionnaire at childbirth 18. Type of delivery is measured using an ad-hoc questionnaire at childbirth 19. Multiple birth status is measured using an ad-hoc questionnaire at childbirth 20. Use of analgesia is measured using an ad-hoc questionnaire at childbirth 21. Duration of labor is measured using an ad-hoc questionnaire at chil

Countries

Spain

Contacts

Public ContactPatricia Catalá Mesón
patricia.catala@urjc.es+34 914888864

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026