NCT05031130

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

August 20, 2021

Last Update Submit

November 15, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Maternal Self-Esteem (MSE)

    Used Maternal Self Report Inventory-Short Form (MSRI-SF)

    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)

    Measure QoL at 32 weeks gestation or 33 weeks gestation (Preintervention)

  • Maternal Self-Esteem (MSE)

    Used Maternal Self Report Inventory-Short Form (MSRI-SF)

    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)

    Measure QoL at 36 weeks gestation or 37 weeks gestation (Postintervention)

Study Arms (2)

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.

Other: Empowered program integrated with family support

Interventions

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.

Experimental group

Eligibility Criteria

Age15 Years - 20 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shurouq Ghalib Qadous

Nablus, Palestinian Territories

Location

Related Publications (1)

  • 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.

Study Officials

  • Shurouq Qadous

    Prince Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 20, 2021

First Posted

September 1, 2021

Study Start

September 29, 2021

Primary Completion

June 20, 2022

Study Completion

August 22, 2022

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations