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

NCT06502730 | Completed DMC

• 1 other identifier: AU-20-4-248
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Empowerment; Competence; Outcome; Interaction

Keywords

COPE;; Maternal Competence;; Maternal Mental Health;; Parent-Infant Interaction;; Preterm neonates

Outcome Measures

Primary Outcomes (3)

• Parenting Sense of Competency Scale (PSOC)

  This scale was developed by Gibaud-Wallston \& Wandersman, 1978, the Chinese version of the PSOC Scale (C-PSOC) to assess the mothers' sense of competence and satisfaction with parenting. The C-PSOC includes 17 items.

  7 days

• Modified Parental Stressor Scale (PSS): NICU

  This scale was developed by (Miles et al. 1993). It is used to assess perceived stress of mothers with preterm infants during the NICU hospitalization of their infant. The PSS:NICU is a 50-item self-report scale that measures parental stress related to four dimensions of the NICU environment: sights and sounds in the NICU (5 items); the infant's appearance (21 items); staff behaviors and communication (13 items), and parent interaction with baby (11 items).

  7 days

• Parent-Infant Interaction Observation (PIIO) Checklist:

  It is an observational Scale developed by (Svanberg, et al., 2013), It is a screening tool for parent-infant interactions for infant aged from 0-6 months. It includes 13 interactional items such as: Infant positioning, eye contact, vocalizations, affect engagement and synchrony, warmth and affection, holding and handling, verbal commenting (mind- mindedness), attunement/ harmony to distress, bodily intrusiveness, expressed expectations, empathic understanding, responsive turn taking, and baby's self-soothing strategies.

  7 days

Study Arms (2)

Control group

NO INTERVENTION

Mothers of preterm neonates who will not receive COPE program.

Study group

EXPERIMENTAL

Mothers of preterm neonates who will receive COPE program.

Behavioral: Creating Opportunities for Parent Empowerment (COPE) Program

Interventions

Creating Opportunities for Parent Empowerment (COPE) Program 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.

Study group

Eligibility Criteria

• Age: 34 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Matrouh University: lead
• Alexandria University: collaborator

Study Sites (1)

Matrouh university

Marsá Maţrūḩ, Egypt

Location

Related Publications (4)

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

  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.

  BACKGROUND

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

  PMID: 8506163 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Seham Saleh

  Matrouh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of pediatric nursing, faculty of nursing

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: January 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 15, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)