Clinical trial NCT05031130: Effects of Empowerment Program Integrated With Family Support on Maternal Self-esteem and Quality of Life Among Palestinian Pregnant Adolescents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Adolescents
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 71
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maternal Self-Esteem (MSE)
timeFrame: Measure MSE at 32 weeks gestation or 33 weeks gestation (Preintervention)
measure: Quality of Life (QoL)
timeFrame: Measure QoL at 32 weeks gestation or 33 weeks gestation (Preintervention)
measure: Maternal Self-Esteem (MSE)
timeFrame: Measure MSE at 36 weeks gestation or 37 weeks gestation (Postintervention)
measure: Quality of Life (QoL)
timeFrame: Measure QoL at 36 weeks gestation or 37 weeks gestation (Postintervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Nablus
country: Palestinian Territory, occupied
facility: Shurouq Ghalib Qadous
Study officials:
affiliation: Prince Songkla University
name: Shurouq Qadous
role: PRINCIPAL_INVESTIGATOR
References: