MAMA NO STRESS Project. The Effects of the "HAPPY MAMA" Intervention

NCT04093791 | Unknown DMC

• 1 other identifier: 80209930587
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the effects of a postpartum intervention in increasing the maternal well-being and self-efficacy of Italian women in the first one to six months after childbirth, as well as in reducing postpartum depression and stress. The intervention will use the motivational interviewing against high levels of daily stress. One third of participants will be exposed to a 3,5 hours group intervention approximately 1 month after delivery, one third will be exposed to an individual intervention in the same period and one third will receive no intervention. Participants will be followed with stress and depression questionnaires.

Conditions

Depression, Postpartum; Stress, Psychological; Postpartum Sadness; Self Efficacy; Mother-Infant Relations

Keywords

postpartum; stress; depression; self efficacy; Mother-Infant Relations

Outcome Measures

Primary Outcomes (1)

• Assessing a change of the Parental Stress Scale (PSS): The main outcome measures are the Parental Stress Scale (PSS) for change between the baseline and the follow-up (four time points).

  The PSS scale consisted of 18 items rated on a 5-point Likert scale. The total score was obtained by summing up the value for each item. A higher score indicates a higher level of parental stress. An Italian version of the questionnaire will be used. A follow-up of the PSS score will be computed.

  4 weeks after the delivery or 2/3 days before the intervention; 2 months after delivery or 2 weeks after the intervention; 3 months after delivery; 6ths after delivery.

Secondary Outcomes (2)

• Assessing a change of the Karitane Parenting Confidence Scale (KPCS). The secondary outcome measures are theKaritane Parenting Confidence Scale (KPCS) for change between the baseline and the follow-up (four time points).

  4 weeks after delivery or 2/3 days before the intervention; 2 months after delivery or 2 weeks after the intervention; 3 months after delivery; 6 months after delivery.

• Assessing a change of the Edinburgh Postnatal Depression Scale (EPDS). The secondary outcome measures are the Edinburgh Postnatal Depression Scale (EPDS) for change between the baseline and the follow-up (four time points).

  4 weeks after delivery or 2/3 days before the intervention; 2 months after delivery or 2 weeks after the intervention; 3 months after delivery; 6 months after delivery.

Study Arms (3)

Collective Intervention "G"

EXPERIMENTAL

HAPPY MAMA intervention will follow the following steps: listening and establishing relationship phases; analysis of the problems; definition of the problem and the goal of intervention. The duration will be of 3.5 hours in one day and the intervention will happen in "Sapienza" University of Rome, in a group of 15 women. This group fill in an on line questtionarie for four times, the first before the intervention.

Behavioral: Collective Intervention "G"

Individual Intervention "I"

EXPERIMENTAL

The same intervention of "G" group (HAPPY MAMA), but at individual level and the intervention will happen at the participants' house. This group fill in an on line questtionarie for four times, the first before the intervention.

Behavioral: Individual Intervention "I"

Control group "C"

NO INTERVENTION

The women from this group will not receive any intervention. This group fill in an on-line questtionarie for four times.

Interventions

Collective Intervention "G" BEHAVIORAL

The steps are: 1. Listening/establishing relationship. This step is characterized by listening and understanding the critical points from the new mothers. The operator maintains a nonjudgmental approach encouraging the women to describe the need for behavioral change. 2. Analysis. The situation must be carefully evaluated, considering the discomfort and emotional distress. The stress situation will be described in a subjective way and they will assign a grade of discomfort for each problem. 3. Assessment. The operator will carry out a multidimensional evaluation of the mothers within the dyad. The operator will evaluate the strategies implemented by the mothers to face problems and the reasons of the failures. 4. Summary and goal of the intervention. The problems detected by the operator will be explained and summarized to the participants. The operator explores ways to implement change.

Also known as: HAPPY MAMA G intervention

Collective Intervention "G"

Individual Intervention "I" BEHAVIORAL

The steps are: 1. Listening/establishing relationship. This step is characterized by listening and understanding the critical points from the new mother. The operator maintains a nonjudgmental approach encouraging the woman to describe the need for behavioral change. 2. Analysis. The situation have be carefully evaluated, considering the discomfort and emotional distress. The stress situation will be described in a subjective way, and she will assign a grade of discomfort for each problem. 3. Assessment. The operator will carry out a multidimensional evaluation of the mothers within the dyad. The operator will evaluate the strategies implemented by the mother to face problems and the reasons of the failures. 4. Summary and goal of the intervention. The problems detected by the operator will be explained and summarized to the participants. The operator explores ways to implement change.

Also known as: HAPPY MAMA I intervention

Individual Intervention "I"

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• women will be excluded from the study if they or their babies have serious health problems;
• the baby was born at \<37 weeks gestation, weighed \<2500 g;
• the baby has the APGAR score \<7 immediately after birth (17).

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (20)

• APGAR V. A proposal for a new method of evaluation of the newborn infant. Curr Res Anesth Analg. 1953 Jul-Aug;32(4):260-7. No abstract available.

  PMID: 13083014 BACKGROUND

• Bennett AE, Kearney JM. Factors Associated with Maternal Wellbeing at Four Months Post-Partum in Ireland. Nutrients. 2018 May 14;10(5):609. doi: 10.3390/nu10050609.

  PMID: 29757937 BACKGROUND

• Beresford BA. Resources and strategies: how parents cope with the care of a disabled child. J Child Psychol Psychiatry. 1994 Jan;35(1):171-209. doi: 10.1111/j.1469-7610.1994.tb01136.x.

  PMID: 8163627 BACKGROUND

• Carpiniello B, Pariante CM, Serri F, Costa G, Carta MG. Validation of the Edinburgh Postnatal Depression Scale in Italy. J Psychosom Obstet Gynaecol. 1997 Dec;18(4):280-5. doi: 10.3109/01674829709080700.

  PMID: 9443138 BACKGROUND

• Cheng CY, Li Q. Integrative review of research on general health status and prevalence of common physical health conditions of women after childbirth. Womens Health Issues. 2008 Jul-Aug;18(4):267-80. doi: 10.1016/j.whi.2008.02.004. Epub 2008 May 12.

  PMID: 18468922 BACKGROUND

• Cheng CY, Fowles ER, Walker LO. Continuing education module: postpartum maternal health care in the United States: a critical review. J Perinat Educ. 2006 Summer;15(3):34-42. doi: 10.1624/105812406X119002.

  PMID: 17541458 BACKGROUND

• Coates R, Ayers S, de Visser R. Women's experiences of postnatal distress: a qualitative study. BMC Pregnancy Childbirth. 2014 Oct 14;14:359. doi: 10.1186/1471-2393-14-359.

  PMID: 25315742 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• Gallagher L, Begley C, Clarke M. Determinants of breastfeeding initiation in Ireland. Ir J Med Sci. 2016 Aug;185(3):663-668. doi: 10.1007/s11845-015-1333-2. Epub 2015 Jul 15.

  PMID: 26174153 BACKGROUND

• Kahn RS, Zuckerman B, Bauchner H, Homer CJ, Wise PH. Women's health after pregnancy and child outcomes at age 3 years: a prospective cohort study. Am J Public Health. 2002 Aug;92(8):1312-8. doi: 10.2105/ajph.92.8.1312.

  PMID: 12144990 BACKGROUND

• Kristensen IH, Simonsen M, Trillingsgaard T, Pontoppidan M, Kronborg H. First-time mothers' confidence mood and stress in the first months postpartum. A cohort study. Sex Reprod Healthc. 2018 Oct;17:43-49. doi: 10.1016/j.srhc.2018.06.003. Epub 2018 Jun 25.

  PMID: 30193719 BACKGROUND

• O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379-407. doi: 10.1146/annurev-clinpsy-050212-185612. Epub 2013 Feb 1.

  PMID: 23394227 BACKGROUND

• Perez-Blasco J, Viguer P, Rodrigo MF. Effects of a mindfulness-based intervention on psychological distress, well-being, and maternal self-efficacy in breast-feeding mothers: results of a pilot study. Arch Womens Ment Health. 2013 Jun;16(3):227-36. doi: 10.1007/s00737-013-0337-z. Epub 2013 Mar 20.

  PMID: 23512648 BACKGROUND

• Coates R, de Visser R, Ayers S. Not identifying with postnatal depression: a qualitative study of women's postnatal symptoms of distress and need for support. J Psychosom Obstet Gynaecol. 2015;36(3):114-21. doi: 10.3109/0167482X.2015.1059418. Epub 2015 Jul 1.

  PMID: 26135567 BACKGROUND

• Tarkka MT, Paunonen M, Laippala P. Factors related to successful breast feeding by first-time mothers when the child is 3 months old. J Adv Nurs. 1999 Jan;29(1):113-8. doi: 10.1046/j.1365-2648.1999.00868.x.

  PMID: 10064289 BACKGROUND

• Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.

  PMID: 7850498 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

  PMID: 20332509 BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.

  PMID: 20332511 BACKGROUND

• Benvenuti P, Ferrara M, Niccolai C, Valoriani V, Cox JL. The Edinburgh Postnatal Depression Scale: validation for an Italian sample. J Affect Disord. 1999 May;53(2):137-41. doi: 10.1016/s0165-0327(98)00102-5.

  PMID: 10360408 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Stress, Psychological; Depression

Condition Hierarchy (Ancestors)

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

Study Officials

• Alice Mannocci

  University "La Sapienza", Department of Public Health and Infectious Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe La Torre

CONTACT

0649694308; giuseppe.latorre@uniroma1.it

Alice Mannocci

CONTACT

alice.mannocci@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly divided in three groups: the one that will follow the collective intervention (G); the one that will follow the Individual Intervention (I) and the control group, that will receive no intervention (C)

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: September 18, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2020
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share