Effects of Empowerment Program Integrated With Family Support on Maternal Self-esteem and Quality of Life Among Palestinian Pregnant Adolescents

NCT ID: NCT05031130

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2022-08-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnant Adolescents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

For the control group, the researcher will provide routine care to pregnant adolescents.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

For the experimental group, the researcher will provide the empowered program integrated with family support plus routine care.

Group Type EXPERIMENTAL

Empowered program integrated with family support

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empowered program integrated with family support

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age from 15 to 20 years.
2. First-time pregnant.
3. Have a single fetus.
4. Gestational age 32 or 33 weeks.
5. Medical history free from diseases such as diabetes mellitus (DM), hypertension, urinary tract infections (UTIs), heart disease, and thyroid disease.
6. Free of complications during the present pregnancy such as preterm labor and gestational hypertension.
7. Have more than check answers on the perinatal screening depression checklist (adopted from Edinburgh Postnatal Depression Scale).
8. Having their own family member (pregnant adolescents' husband, own mother, mother-in-law, her sister, or sister-in-law) during giving the intervention.
9. Able to read, write, and communicate clearly in the Arabic language.
10. Living in Nablus City.

The family member will be included in any of the following criteria are present.

1. Being with the pregnant adolescent during the intervention and continue giving support at home.
2. The available phone number for contact while family members are at home.

Exclusion Criteria

1. Pregnant adolescents who experience any serious obstetric complications during the study such as preterm labor, gestational hypertension, and bleeding disorders.
2. Pregnant adolescent who is not able to follow or complete the intervention program.
3. Family member who is unable to accompany the pregnant adolescent during the intervention delivery at the primary health care clinic.
4. Family member who is unable to give social support to the pregnant adolescent at home.
5. Pregnant adolescents or family members in case one of them withdraws from the study the other will be excluded from the study.
Minimum Eligible Age

15 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shurouq Ghalib Mousa Qadous

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shurouq Qadous

Role: PRINCIPAL_INVESTIGATOR

Prince Songkla University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shurouq Ghalib Qadous

Nablus, , Palestinian Territories

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Palestinian Territories

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39224986 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PSU IRB 2021-St-Nur 009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Reducing Adolescent Pregnancy
NCT04120376 COMPLETED NA