Condition category
Not Applicable
Date applied
08/02/2016
Date assigned
22/02/2016
Last edited
18/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Becoming a new mother is a very challenging time, particularly when the mother is an adolescent herself. For these girls, bonding and interacting with their babies can be difficult and so steps must be taken to help them form a healthy and nurturing relationship with their children. A possible reason for this is that many young mothers do not have a strong support network, and so can feel alone and unhappy while caring for an infant. This study is looking at an early parenting project which is designed to help new parents to bond with their babies. Trained community workers will visit first-time adolescent mothers (aged 10-19) in their homes during late pregnancy and the post-partum (after the child is born) period, demonstrating sensitive interactive behavior and providing constructive feedback to help parents understand and respond to the developmental needs of their infants. The aim of this study is to look at the effects of this project on new mothers in the Sonsonate province (El Salvador) in order to find out whether it is an effective way of helping new mothers to build nurturing, non-violent relationships from the moment their babies are born.

Who can participate?
Girls aged between 10 and 19 who are in their last 11 weeks of pregnancy with their first child, who live in Sosonate province, El Salvador.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive 16 visits from by community workers (CW), which take place twice in late pregnancy, weekly for the first eight weeks after they have given birth, every two weeks for a further two months and then monthly visits for two additional months up to six months. During the visits, the CW’s provide support to the new mothers, in order to help mothers to better understand their child and their development. The sessions cover a range of topics, such as the mother’s immediate support network, the birth process, infant care and early child development. The mothers are also given taught how to sympathetically manage infant behavioral problems (sleeping, feeding and crying) and encouraged to talk to their babies and to engage in play. Participants in the second group receive standard post-partum care only which consists of regular doctors’ appointments for both mother and baby. At the start of the study and then again after six months, participants in both groups are observed interacting with their babies in order to judge parenting skills and how well the mother is able to interact with her baby.

What are the possible benefits and risks of participating?
Participants who take part in the parenting project may benefit from improvements to their parenting skills which could improve the relationship with their child. Participants also benefit from receiving help at no cost if postpartum depression or violence in their relationship is found. There is a risk that some participants may find talking about their problems to be distressing, however they can be referred to counseling or specialized services if this is the case.

Where is the study run from?
Clinics in the municipalities of Nahuizalco, Acajutla, Izalco and Juayúa, in Sosonate province (El Salvador)

When is the study starting and how long is it expected to run for?
January 2016 to June 2017

Who is funding the study?
International Planned Parenthood Federation, Western Hemisphere Region (USA)

Who is the main contact?
1. Dr Jose Angel Portillo Henriquez (public)
2. Professor Peter J Cooper (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Jose Angel Portillo Henriquez

ORCID ID

Contact details

Edificio Pro-Familia
25 Avenida Norte # 583
San Salvador
1338
El Salvador

Type

Scientific

Additional contact

Prof Peter J Cooper

ORCID ID

http://orcid.org/0000-0002-8978-3448

Contact details

School of psychology and clinical language sciences
University of Reading
Whiteknights
Reading
RG6 6AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An early parenting intervention for adolescent mothers in El Salvador: A pilot randomized control trial

Acronym

Study hypothesis

1. Participation in an early parenting intervention increases maternal sensitivity for first-time mothers aged 10-19 in El Salvador
2. Participation in the intervention decreases maternal intrusiveness for first-time mothers aged 10-19 in El Salvador
3. Participation in the intervention results in better emotional regulation for infants aged 6 months in El Salvador

Ethics approval

Comité Nacional de Ética de la Investigación en Salud, del Consejo Superior de Salud Publica (CSSP), del Ministerio de Salud de la República de El Salvador, 16/12/2015, ref: CNEIS/2015/035

Study design

Pilot randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

1. Early childhood care and development
2. Gender based violence

Intervention

The intervention is a home visiting program developed and evaluated by Peter Cooper and Lynne Murray in Khayelitsha, South Africa (Cooper et al, 2009), targeted at first-time mothers aged 10-19 in the last stage of pregnancy and up to 6 months post-partum. A total of 64 first-time adolescent mothers will be recruited to participate in the study, during their last trimester, and will be randomly assigned to either control (32) or intervention groups (32) at the time of recruitment using a random number generator. All participants will be screened for maternal depression and gender-based violence.

Control group: Participants will receive standard postpartum care consisting of regular checkups with obstetricians and pediatrician.

Intervention group: In addition to standard care, participants will receive a home visiting program provided by community workers (CW). Each mother will be visited by the CW 16 times, two visits in the late antenatal period, weekly visits in the first eight postnatal weeks, followed by a visit every two weeks for a further two months and then monthly visits for two additional months up to six months postpartum. The visits will follow a fully specified manual that covers topics related to mother’s support structure, the birth process, infant care and early child development. In the context of a supportive counseling framework, CW will provide will provide support to the first time mothers, seeking to enhance maternal sensitivity to infant communication and development. In addition, mothers will be given support in sympathetically managing infant behavioral problems (sleeping, feeding and crying) and encouraged to talk to their babies and to engage in play. Other caregivers, particularly fathers, will be strongly encouraged to participate in the intervention sessions. The total duration of the intervention could range between 8-6 months depending on the delivery date of each participant.

All participants (control and intervention groups) will receive a follow-up assessment at six months post-partum.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Maternal style (sensitivity and intrusiveness) is rated from the mother-infant face-to-face interaction task using the Global Rating Scale at 6 months
2. Infant emotion regulation is rated from the mother-infant face-to-face still-face (FFSF) task using the Regulatory Scoring System at 6 months

Secondary outcome measures

1. Maternal Depression is measured using the Edinburgh Postnatal Depression Scale at baseline, 3 and 6 months
2. Gender Based Violence is measured using the GBV screening protocol (IPPF/WHR, 2004) at baseline and 6 months

Overall trial start date

01/01/2016

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adolescents between 10 and 19 years of age.
2. Primiparous women in their third trimester of pregnancy
3. Lack of medical complications during pregnancy
4. Delivery not before 36 weeks gestation
5. Women who have a permanent residency so that they are available for the duration of the project (up to 6 months of age of the infant)
6. Resident in urban and rural communities of the municipalities of Nahuizalco, Acajutla, Izalco and Juayúa, Sosonate province
7. Willing and capable to give their written consent (informed consent for minors will be obtained according to the specific age limits of the country)

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

A non-probability sample of 64 pregnant primiparous adolescents that fulfill the inclusion criteria, from the urban and rural communities of the municipalities of Nahuizalco, Acajutla, Izalco and Juayúa in the province of Sonsonate will be enrolled in the study.

Participant exclusion criteria

1. Maternal physical or mental disability
2. Significant infant congenital abnormality

Recruitment start date

14/03/2016

Recruitment end date

30/06/2016

Locations

Countries of recruitment

El Salvador

Trial participating centre

Nahuizalco Clinic
1ª. Calle Poniente Barrio La Trinidad Frente a Casa Comunal Nahuizalco
Sonsonate
-
El Salvador

Trial participating centre

Los Arenales Clinic
Carretera a los Naranjos Hacienda El Águila Cantón Los Arenales Nahuizalco
Sonsonate
-
El Salvador

Trial participating centre

Acajutla Clinic
Av. Pedro de Alvarado Blvd. 25 de Febrero Frente Alcaldía Municipal de Acajutla Acajutla
Sonsonate
-
El Salvador

Trial participating centre

Metalio Clinic
Colonia San José Calle Principal Cantón Metalío Acajutla
Sonsonate
-

Trial participating centre

Izalco Clinic
9ª Calle Oriente Barrio La Otra Banda Izalco
Sonsonate
-
El Salvador

Trial participating centre

Dr. Francisco Magaña Herrera (Juayúa) Clinic
Calle Monseñor Romero Poniente y 5ª. Av. Sur Barrio San José Juayúa
Sonsonate
-
El Salvador

Trial participating centre

San Jose La Majada
Carretera a los Naranjos Cantón San José de la Majada Juayúa
Sonsonate
-
El Salvador

Trial participating centre

Pro-Familia Clinic
5ta. Calle Poniente #1-3 Barrio El Calvario
Sonsonate
-
El Salvador

Sponsor information

Organisation

International Planned Parenthood Federation, Western Hemisphere Region

Sponsor details

125 Maiden Lane
9th Floor
New York
10038
United States of America

Sponsor type

Other

Website

Funders

Funder type

Charity

Funder name

International Planned Parenthood Federation, Western Hemisphere Region

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned dissemination of results nationally with key-stakeholders in El Salvador, both in the public and private sectors.
2. Planned publication in at least one article in an international peer reviewed journal and one article in a Latin American journal.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes