Pregnant AdolescentsNCT05031130
Effects of Empowerment Program Integrated With Family Support on Maternal Self-esteem and Quality of Life Among Palestinian Pregnant Adolescents
A study testing Empowered program integrated with family support in people with Pregnant Adolescents, run by Prince of Songkla University at 1 site in Palestinian Territories.
Trial summary
Adolescent pregnancy leads to increase risks and complications for the adolescent mother and her newborn. This study aims to examine the effects of empowerment program integrated with family support on maternal self-esteem and quality of life among Palestinian pregnant adolescents. Read more about this study
- Who is it for?
- Ages 15 to 20 years, women only
- Conditions the study is for
- Pregnant Adolescents
- What is being tested?
- Empowered program integrated with family support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 29 Sep 2021to 22 Aug 2022
- 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 15 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age from 15 to 20 years.
- First-time pregnant.
- Have a single fetus.
- Gestational age 32 or 33 weeks.
- Medical history free from diseases such as diabetes mellitus (DM), hypertension, urinary tract infections (UTIs), heart disease, and thyroid disease.
- Free of complications during the present pregnancy such as preterm labor and gestational hypertension.
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- Have more than check answers on the perinatal screening depression checklist (adopted from Edinburgh Postnatal Depression Scale).
- Having their own family member (pregnant adolescents' husband, own mother, mother-in-law, her sister, or sister-in-law) during giving the intervention.
- Able to read, write, and communicate clearly in the Arabic language.
- Living in Nablus City.
- The family member will be included in any of the following criteria are present.
- Being with the pregnant adolescent during the intervention and continue giving support at home.
- The available phone number for contact while family members are at home.
Who cannot join
- Pregnant adolescents who experience any serious obstetric complications during the study such as preterm labor, gestational hypertension, and bleeding disorders.
- Pregnant adolescent who is not able to follow or complete the intervention program.
- Family member who is unable to accompany the pregnant adolescent during the intervention delivery at the primary health care clinic.
- Family member who is unable to give social support to the pregnant adolescent at home.
- Pregnant adolescents or family members in case one of them withdraws from the study the other will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Empowerment Program Integrated With Family Support on Maternal Self-Esteem and Quality of Life Among Pregnant Adolescents in Palestine: A Randomized Controlled Trial
Adolescent pregnancy leads to increase risks and complications for the adolescent mother and her newborn. This study aims to examine the effects of empowerment program integrated with family support on maternal self-esteem and quality of life among Palestinian pregnant adolescents. A randomized controlled single-blind trial, pretest-posttest controlled group design will be conducted with 62 participants ( control group =31, experimental group = 31). Research instruments will include the instruments for data collection, instruments for research intervention, and control instruments for intervention evaluation. The instruments for data collection will be consists of a demographic data form, Maternal Self-Report Inventory (MSRI), and WHO quality of life-BREF (WHOQoL-BREF, 1997). The empowerment program integrated with family support will be the research intervention instruments and included five steps; step 1: building relationships and creating collaboration, step 2: discovering reality, step 3: critical reflection, step 4: taking charge, and step 5: holding on. Control instruments through Family Support Questionnaire (FSQ) will be used to evaluate the effectiveness of the intervention program. Data will be analyzed using mean and standard deviations, frequency distribution, percentage, and chi-square test, and t-test. This program is expected to guide nurses to empower pregnant adolescents in enhancing maternal self-esteem and improve their quality of life.
- Conditions
- Pregnant Adolescents
- Being tested
- Empowered program integrated with family support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered program integrated with family supportOther
The empowered program integrated with family support is an intervention consisted of five steps that will be given when pregnant adolescents on gestational age 32 or 33 weeks the second meeting will be when the pregnant adolescents on gestational age 34 or 35 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | For the control group, the researcher will provide routine care to pregnant adolescents. |
| Experimental group | Experimental | For the experimental group, the researcher will provide the empowered program integrated with family support plus routine care. Receives: Other: Empowered program integrated with family support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Self-Esteem (MSE)
Used Maternal Self Report Inventory-Short Form (MSRI-SF)
Measured: Measure MSE at 32 weeks gestation or 33 weeks gestation (Preintervention)
Quality of Life (QoL)
Used World Health Organization Quality of Life- BREF (WHOQoL-BREF)
Measured: Measure QoL at 32 weeks gestation or 33 weeks gestation (Preintervention)
Maternal Self-Esteem (MSE)
Used Maternal Self Report Inventory-Short Form (MSRI-SF)
Measured: Measure MSE at 36 weeks gestation or 37 weeks gestation (Postintervention)
Quality of Life (QoL)
Used World Health Organization Quality of Life- BREF (WHOQoL-BREF)
Measured: Measure QoL at 36 weeks gestation or 37 weeks gestation (Postintervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start29 Sep 2021
- Primary completion20 Jun 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant AdolescentsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shurouq Ghalib Mousa Qadous, Prince of Songkla University
- Investigators
- Shurouq Qadous, Principal investigator, Prince Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031130
- Sponsor's protocol ID
- PSU IRB 2021-St-Nur 009
- Status last verified
- Nov 2023
- First submitted
- 20 Aug 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qadous SG, Chunuan S, Chatchawet W. Effectiveness of a nurse-led family empowerment program to improve the quality of life among pregnant adolescents: A randomized controlled trial. Int J Gynaecol Obstet. 2025 Feb;168(2):716-723. doi: 10.1002/ijgo.15881. Epub 2024 Sep 3.
PubMed 39224986
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Empowerment Program Integrated With Family Support on Maternal Self-Esteem and Quality of Life Among Pregnant Adolescents in Palestine: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05031130
- Acronym / sponsor ID
- PSU IRB 2021-St-Nur 009
- Conditions
- Pregnant Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 1 Sep 2021 (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.
Adolescent pregnancy leads to increase risks and complications for the adolescent mother and her newborn. This study aims to examine the effects of empowerment program integrated with family support on maternal self-esteem and quality of life among Palestinian pregnant adolescents. A randomized controlled single-blind trial, pretest-posttest controlled group design will be conducted with 62 participants ( control group =31, experimental group = 31). Research instruments will include the instruments for data collection, instruments for research intervention, and control instruments for intervention evaluation. The instruments for data collection will be consists of a demographic data form, Maternal Self-Report Inventory (MSRI), and WHO quality of life-BREF (WHOQoL-BREF, 1997). The empowerment program integrated with family support will be the research intervention instruments and included five steps; step 1: building relationships and creating collaboration, step 2: discovering reality, step 3: critical reflection, step 4: taking charge, and step 5: holding on. Control instruments through Family Support Questionnaire (FSQ) will be used to evaluate the effectiveness of the intervention program. Data will be analyzed using mean and standard deviations, frequency distribution, percentage, and chi-square test, and t-test. This program is expected to guide nurses to empower pregnant adolescents in enhancing maternal self-esteem and improve their quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –For the control group, the researcher will provide routine care to pregnant adolescents. |
| Experimental group | Experimental | Other: Empowered program integrated with family supportFor the experimental group, the researcher will provide the empowered program integrated with family support plus routine care. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Age from 15 to 20 years.
- First-time pregnant.
- Have a single fetus.
- Gestational age 32 or 33 weeks.
- Medical history free from diseases such as diabetes mellitus (DM), hypertension, urinary tract infections (UTIs), heart disease, and thyroid disease.
Key exclusion criteria (5 listed)
- Pregnant adolescents who experience any serious obstetric complications during the study such as preterm labor, gestational hypertension, and bleeding disorders.
- Pregnant adolescent who is not able to follow or complete the intervention program.
- Family member who is unable to accompany the pregnant adolescent during the intervention delivery at the primary health care clinic.
- Family member who is unable to give social support to the pregnant adolescent at home.
- Pregnant adolescents or family members in case one of them withdraws from the study the other will be excluded from the study.
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 |
|---|---|---|
| Empowered program integrated with family supportThe empowered program integrated with family support is an intervention consisted of five steps that will be given when pregnant adolescents on gestational age 32 or 33 weeks the second meeting will be when the pregnant adolescents on gestational age 34 or 35 weeks. | Other | Experimental group |
Primary outcome
Maternal Self-Esteem (MSE)
Time frame: Measure MSE at 32 weeks gestation or 33 weeks gestation (Preintervention)
Used Maternal Self Report Inventory-Short Form (MSRI-SF)
Quality of Life (QoL)
Time frame: Measure QoL at 32 weeks gestation or 33 weeks gestation (Preintervention)
Used World Health Organization Quality of Life- BREF (WHOQoL-BREF)
Maternal Self-Esteem (MSE)
Time frame: Measure MSE at 36 weeks gestation or 37 weeks gestation (Postintervention)
Used Maternal Self Report Inventory-Short Form (MSRI-SF)
Quality of Life (QoL)
Time frame: Measure QoL at 36 weeks gestation or 37 weeks gestation (Postintervention)
Used World Health Organization Quality of Life- BREF (WHOQoL-BREF)
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 18 Nov 2023.
- Derived from this study: PubMed 39224986Qadous SG, Chunuan S, Chatchawet W. Effectiveness of a nurse-led family empowerment program to improve the quality of life among pregnant adolescents: A randomized controlled trial. Int J Gynaecol Obstet. 2025 Feb;168(2):716-723. doi: 10.1002/ijgo.15881. Epub 2024 Sep 3.
- 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.
Shurouq Qadous principal investigator
Prince Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered program integrated with family support in people with Pregnant Adolescents, run by Prince of Songkla University at 1 site in Palestinian Territories.
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 13 inclusion and 5 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 18 Nov 2023. 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 Palestinian Territories. 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?
Maternal Self-Esteem (MSE) (time frame: Measure MSE at 32 weeks gestation or 33 weeks gestation (Preintervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031130, which also lists 1 linked publication.
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 18 Nov 2023.