COPE Program , Mental Health, Mother- Infant Interaction, Sense of Competence

NCT ID: NCT06502730

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2024-10-15

Brief Summary

The aim of the study is to:

• Evaluate the effect of creating opportunities for parent empowerment program on maternal sense of competence, mental health outcome and mother-infant interaction.

RESEARCH HYPOTHESES

• Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high level of competence than those who don't.
• Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit less stress level than those who don't.
• Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high interaction than those who don't.

The mothers of preterm neonates will be assigned into two equal groups as follows:

• Study group (group II) mothers of preterm neonates who will receive COPE program.
• Control group (group I) mothers of preterm neonates who will not receive COPE program.

Detailed Description

• Research Design: A quasi-experimental (pre-posttest) research design will be used.
• Setting: The study will be conducted at the Neonatal Intensive Care Unit at Smouha Specialty Hospital in Alexandria.
• Subjects: A convenience sampling of 60 mothers of preterm infants who admitted to the previously mentioned setting
• During the 1st day of preterm admission to NICU data concerning characteristics of neonates and their mothers' in both groups will be obtained from medical records using tool I.
• The pretest will be conducted to the mothers of neonates on the 1st day of admission in the NICU to assess mothers' sense of competence and perceived stress by interviewing them to collect data using tool II, III and mother infant interaction in both groups by observation using tool IV.
• After completion of the pretest, the mothers in the study group will receive COPE program, then at the 7th day of the study posttest will be done for both group

Conditions

Empowerment; Competence; Outcome; Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Mothers of preterm neonates who will not receive COPE program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study group

Mothers of preterm neonates who will receive COPE program.

Group Type: EXPERIMENTAL

Creating Opportunities for Parent Empowerment (COPE) Program

Intervention Type: BEHAVIORAL

It helps to recognize the critical role of parents and encourage taking an active role in their neonate's care, engaging in dyadic interaction with their neonate. COPE program consists of two types of educational information; as teaching parents about normal physical, developmental and behavioral characteristics of their preterm infants and the best ways to interact with them and facilitate their development.

Interventions

Creating Opportunities for Parent Empowerment (COPE) Program

It helps to recognize the critical role of parents and encourage taking an active role in their neonate's care, engaging in dyadic interaction with their neonate. COPE program consists of two types of educational information; as teaching parents about normal physical, developmental and behavioral characteristics of their preterm infants and the best ways to interact with them and facilitate their development.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• The mother age more than 20 years, educated and has no experience of premature birth
• The mother has no postpartum discomforts (such as, bleeding, depression or pain
• Premature neonates( gestational age 37 weeks)
• Birth weight < 2500 g or > 1500 g (LBW)
• Five-minute Apgar score > 7
• Neonate not with any medically restricted conditions (e.g., intraventricular hemorrhage or intracerebral hemorrhage (grades III and IV).
• Neonate not on ant ventilation assisted devices, such as ventilator or CPAP

Exclusion Criteria

-

• Minimum Eligible Age: 34 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: collaborator

Matrouh University

OTHER

Sponsor Role: lead

Responsible Party

Seham El-Sayed Saleh Hassan

Assistant Professor of pediatric nursing, faculty of nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seham Saleh

Role: PRINCIPAL_INVESTIGATOR

Matrouh University

Locations

Matrouh university

Marsá Maţrūḩ, , Egypt

Countries

Egypt

References

Gibaud-Wallston J, Wandersman LP. Parenting sense of competence scale. 1978. https://researchingparents.wordpress.com/2013/02/15/parentingsense- of-competence-psoc/

Reference Type: BACKGROUND

Jnaneswari. K, Dr. Manjubala Dash. Effect of COPE Program (Creating Opportunities for Parent Empowerment) on Maternal Stress and Parent Neonate Interaction among NICU Mothers. Archives of Reproductive Medicine and Sexual Health. 2020; 3(1): 16-23.

Reference Type: BACKGROUND

Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.

Reference Type: BACKGROUND

PMID: 8506163 (View on PubMed)

P.O. Svanberg, J. Barlow & W. Tigbe (2013) The Parent-Infant Interaction Observation Scale: reliability and validity of a screening tool, Journal of Reproductive and Infant Psychology, 31:1, 5-14, DOI: 10.1080/02646838.2012.751586

Reference Type: BACKGROUND

Other Identifiers

AU-20-4-248

Identifier Type: -

Identifier Source: org_study_id