Adolescent MotherNCT06355674
Adolescent Mother and Breastfeeding Education
A study testing Breastfeeding education provided with Lactation Simulation Model in people with Adolescent Mother, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Mother
- What is being tested?
- Breastfeeding education provided with Lactation Simulation Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2024to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Giving birth vaginally between the 37th and 40th gestational weeks,
- Being under 18 years of age,
- Primigravida,
- Not having any systemic/chronic diseases,
- Willing to breastfeed,
- Having received breastfeeding counseling provided by the hospital,
- Being able to speak Turkish, and
- Adolescent mothers in the postnatal 1st and 2nd weeks will be included in the study.
Who cannot join
- Mothers giving birth before the 37th gestational week or after the 40th gestational week,
- Those with barriers hindering effective communication,
- Those unable to speak Turkish,
- Mothers who have not received breastfeeding counseling from the hospital,
- Non-breastfeeding mothers,
- Those experiencing interruptions in breastfeeding due to seasonal work or any other reason,
- Those supplementing breastfeeding with formula,
- Adolescent mothers who discontinue breastfeeding education provided through LSM will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Breastfeeding Education Given to Adolescent Mothers With Lactation Simulation Model on Maternal Breastfeeding Self-Efficacy, Maternal Infant Attachment, and Infant Anthropometric Measurements
In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. 10% of adolescents under the age of 15 in the world are forced to have sexual intercourse and as a result, unwanted teenage pregnancies occur. In high-income countries like Latin America, there is a high prevalence of adolescent non-marital pregnancies. When considering the fertility, health, and social outcomes of adolescence, it emerges as a significant issue. Adolescent motherhood carries numerous adverse effects from both demographic and social perspectives.
In pregnancies occurring during adolescence, both maternal and infant mortality rates are two to three times higher compared to pregnancies at later ages. Many infant and child deaths occur due to preventable causes. Breastfeeding is a significant factor in reducing infant and child mortality. Since infants born to adolescent mothers are at higher risk of death and illness, breastfeeding these infants becomes even more important. However, one of the significant challenges adolescent mothers face during the postpartum period is initiating and maintaining lactation. Research has shown that maternal age plays a significant role in initiating and sustaining breastfeeding, with a strong positive correlation between maternal age and duration of breastfeeding. This study was designed as a randomized controlled trial to examine the effect of breastfeeding education provided to adolescent mothers on maternal breastfeeding self-efficacy, mother-infant attachment, and infant anthropometric measurements.
- Conditions
- Adolescent Mother
- Being tested
- Breastfeeding education provided with Lactation Simulation Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding education provided with Lactation Simulation ModelBehavioural
The Lactation Simulation Model (LSM) is a high-fidelity simulator designed for interactive education, which educators can utilize for practical and wearable breastfeeding training. It is wearable like a shirt and is secured onto the chest by passing it over the shoulders and fastening it with a safety belt from the back. This allows the safety belt to be adjusted according to different body types and weights.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding education group | Experimental | Adolescent mothers included in the breastfeeding education group will receive practical breastfeeding training using the lactation simulation model and newborn baby mannequin for 1.5-2 hours conducted by the researchers.
One week and one month after postnatal day 7, the "Postnatal Breastfeeding Self-Efficacy Scale - Short Form" and the "Maternal-Infant Attachment Scale" will be administered again to mothers in both groups.
Anthropometric measurements of all babies will be repeated and recorded at the end of the 1st, 2nd, 3rd, and 4th weeks following postnatal day 7.
After the completion of the study, adolescent mothers in the control group who request it will receive breastfeeding education using the lactation simulation model provided by the researchers. Receives: Behavioral: Breastfeeding education provided with Lactation Simulation Model |
| Control group | No intervention | Adolescent mothers in the control group will continue with routine breastfeeding and follow-up at the family health center. One week and one month after postnatal day 7, the "Postnatal Breastfeeding Self-Efficacy Scale - Short Form" and the "Maternal-Infant Attachment Scale" will be administered again to mothers in both groups. Anthropometric measurements of all babies will be repeated and recorded at the end of the 1st, 2nd, 3rd, and 4th weeks following postnatal day 7. After the completion of the study, adolescent mothers in the control group who request it will receive breastfeeding education using the lactation simulation model provided by the researchers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postnatal Breastfeeding Self-Efficacy Scale-Short Form
The short form of the scale consists of a total of 14 items and is a 5-point Likert scale. Scores on the scale can range from 14 to 70 points. A higher score indicates higher maternal breastfeeding self-efficacy.
Measured: 4 months
Maternal-Infant Attachment Scale
The scale consists of a total of eight items rated on a four-point Likert scale. An increase in scores on the scale indicates an improvement in mother-infant attachment.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start12 Feb 2024
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent MotherStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maksude YILDIRIM, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355674
- Sponsor's protocol ID
- HRÜ/23.21.12
- Status last verified
- Sep 2025
- First submitted
- 23 Mar 2024
- Last updated
- 22 Sep 2025
- Results posted
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breastfeeding Education Given to Adolescent Mothers With Lactation Simulation Model on Maternal Breastfeeding Self-Efficacy, Maternal Infant Attachment, and Infant Anthropometric Measurements
- ClinicalTrials.gov ID
- NCT06355674
- Acronym / sponsor ID
- HRÜ/23.21.12
- Conditions
- Adolescent Mother
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 9 Apr 2024 (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.
In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. 10% of adolescents under the age of 15 in the world are forced to have sexual intercourse and as a result, unwanted teenage pregnancies occur. In high-income countries like Latin America, there is a high prevalence of adolescent non-marital pregnancies. When considering the fertility, health, and social outcomes of adolescence, it emerges as a significant issue. Adolescent motherhood carries numerous adverse effects from both demographic and social perspectives.
In pregnancies occurring during adolescence, both maternal and infant mortality rates are two to three times higher compared to pregnancies at later ages. Many infant and child deaths occur due to preventable causes. Breastfeeding is a significant factor in reducing infant and child mortality. Since infants born to adolescent mothers are at higher risk of death and illness, breastfeeding these infants becomes even more important. However, one of the significant challenges adolescent mothers face during the postpartum period is initiating and maintaining lactation. Research has shown that maternal age plays a significant role in initiating and sustaining breastfeeding, with a strong positive correlation between maternal age and duration of breastfeeding. This study was designed as a randomized controlled trial to examine the effect of breastfeeding education provided to adolescent mothers on maternal breastfeeding self-efficacy, mother-infant attachment, and infant anthropometric measurements.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding education group | Experimental | Behavioral: Breastfeeding education provided with Lactation Simulation ModelAdolescent mothers included in the breastfeeding education group will receive practical breastfeeding training using the lactation simulation model and newborn baby mannequin for 1.5-2 hours conducted by the researchers. One week and one month after postnatal day 7, the "Postnatal Breastfeeding Self-Efficacy Scale - Short Form" and the "Maternal-Infant Attachment Scale" will be administered again to mothers in both groups. Anthropometric measurements of all babies will be repeated and recorded at the end of the 1st, 2nd, 3rd, and 4th weeks following postnatal day 7. After the completion of the study, adolescent mothers in the control group who request it will receive breastfeeding education using the lactation simulation model provided by the researchers. |
| Control group | No intervention | –Adolescent mothers in the control group will continue with routine breastfeeding and follow-up at the family health center. One week and one month after postnatal day 7, the "Postnatal Breastfeeding Self-Efficacy Scale - Short Form" and the "Maternal-Infant Attachment Scale" will be administered again to mothers in both groups. Anthropometric measurements of all babies will be repeated and recorded at the end of the 1st, 2nd, 3rd, and 4th weeks following postnatal day 7. After the completion of the study, adolescent mothers in the control group who request it will receive breastfeeding education using the lactation simulation model provided by the researchers. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Giving birth vaginally between the 37th and 40th gestational weeks,
- Being under 18 years of age,
- Primigravida,
- Not having any systemic/chronic diseases,
- Willing to breastfeed,
Key exclusion criteria (8 listed)
- Mothers giving birth before the 37th gestational week or after the 40th gestational week,
- Those with barriers hindering effective communication,
- Those unable to speak Turkish,
- Mothers who have not received breastfeeding counseling from the hospital,
- Non-breastfeeding mothers,
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 |
|---|---|---|
| Breastfeeding education provided with Lactation Simulation ModelThe Lactation Simulation Model (LSM) is a high-fidelity simulator designed for interactive education, which educators can utilize for practical and wearable breastfeeding training. It is wearable like a shirt and is secured onto the chest by passing it over the shoulders and fastening it with a safety belt from the back. This allows the safety belt to be adjusted according to different body types and weights. | Behavioural | Breastfeeding education group |
Primary outcome
Postnatal Breastfeeding Self-Efficacy Scale-Short Form
Time frame: 4 months
The short form of the scale consists of a total of 14 items and is a 5-point Likert scale. Scores on the scale can range from 14 to 70 points. A higher score indicates higher maternal breastfeeding self-efficacy.
Maternal-Infant Attachment Scale
Time frame: 4 months
The scale consists of a total of eight items rated on a four-point Likert scale. An increase in scores on the scale indicates an improvement in mother-infant attachment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding education provided with Lactation Simulation Model in people with Adolescent Mother, run by Adiyaman University at 1 site in Turkey (Türkiye).
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postnatal Breastfeeding Self-Efficacy Scale-Short Form (time frame: 4 months). The study lists 2 primary outcomes in all. 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 Sep 2025.