- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05031130
Effects of Empowerment Program Integrated With Family Support on Maternal Self-esteem and Quality of Life Among Palestinian Pregnant Adolescents
November 15, 2023 updated by: Shurouq Ghalib Mousa Qadous, Prince of Songkla University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nablus, Palestinian Territory, occupied
- Shurouq Ghalib Qadous
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
For the control group, the researcher will provide routine care to pregnant adolescents.
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Experimental: Experimental group
For the experimental group, the researcher will provide the empowered program integrated with family support plus routine care.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maternal Self-Esteem (MSE)
Time Frame: Measure MSE at 32 weeks gestation or 33 weeks gestation (Preintervention)
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Used Maternal Self Report Inventory-Short Form (MSRI-SF)
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Measure MSE at 32 weeks gestation or 33 weeks gestation (Preintervention)
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Quality of Life (QoL)
Time Frame: Measure QoL at 32 weeks gestation or 33 weeks gestation (Preintervention)
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Used World Health Organization Quality of Life- BREF (WHOQoL-BREF)
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Measure QoL at 32 weeks gestation or 33 weeks gestation (Preintervention)
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Maternal Self-Esteem (MSE)
Time Frame: Measure MSE at 36 weeks gestation or 37 weeks gestation (Postintervention)
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Used Maternal Self Report Inventory-Short Form (MSRI-SF)
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Measure MSE at 36 weeks gestation or 37 weeks gestation (Postintervention)
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Quality of Life (QoL)
Time Frame: Measure QoL at 36 weeks gestation or 37 weeks gestation (Postintervention)
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Used World Health Organization Quality of Life- BREF (WHOQoL-BREF)
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Measure QoL at 36 weeks gestation or 37 weeks gestation (Postintervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shurouq Qadous, Prince Songkla University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2021
Primary Completion (Actual)
June 20, 2022
Study Completion (Actual)
August 22, 2022
Study Registration Dates
First Submitted
August 20, 2021
First Submitted That Met QC Criteria
August 28, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- PSU IRB 2021-St-Nur 009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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