EmpowermentNCT06502730
COPE Program , Mental Health, Mother- Infant Interaction, Sense of Competence
A study testing Creating Opportunities for Parent Empowerment (COPE) Program in people with Empowerment and Competence, run by Matrouh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 34 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Empowerment, Competence, Outcome
- What is being tested?
- Creating Opportunities for Parent Empowerment (COPE) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2024to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nursing Led Interventions: Effect of Creating Opportunities for Parent Empowerment Program on Mother- Infant Interaction, Sense of Competence and Mental Health Outcome.
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.
Read more
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.
Read the 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
- Being tested
- Creating Opportunities for Parent Empowerment (COPE) Program
- Keywords
- COPE;, Maternal Competence;, Maternal Mental Health;, Parent-Infant Interaction;, Preterm neonates
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creating Opportunities for Parent Empowerment (COPE) ProgramBehavioural
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Creating Opportunities for Parent Empowerment (COPE) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start25 Jan 2024
- Primary completion30 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EmpowermentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matrouh University
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Principal investigator, Seham El-Sayed Saleh Hassan, Matrouh University
- Investigators
- Seham Saleh, Principal investigator, Matrouh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502730
- Sponsor's protocol ID
- AU-20-4-248
- Status last verified
- Mar 2025
- First submitted
- 9 Jul 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibaud-Wallston J, Wandersman LP. Parenting sense of competence scale. 1978. https://researchingparents.wordpress.com/2013/02/15/parentingsense- of-competence-psoc/
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.
Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
PubMed 8506163P.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
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Led Interventions: Effect of Creating Opportunities for Parent Empowerment Program on Mother- Infant Interaction, Sense of Competence and Mental Health Outcome.
- ClinicalTrials.gov ID
- NCT06502730
- Acronym / sponsor ID
- AU-20-4-248
- Conditions
- Empowerment, Competence, Outcome, Interaction
- Keywords
- COPE;, Maternal Competence;, Maternal Mental Health;, Parent-Infant Interaction;, Preterm neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Matrouh UniversityUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Mothers of preterm neonates who will not receive COPE program. |
| Study group | Experimental | Behavioral: Creating Opportunities for Parent Empowerment (COPE) ProgramMothers of preterm neonates who will receive COPE program. |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creating Opportunities for Parent Empowerment (COPE) ProgramIt 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. | Behavioural | Study group |
Primary outcome
Parenting Sense of Competency Scale (PSOC)
Time frame: 7 days
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.
Modified Parental Stressor Scale (PSS): NICU
Time frame: 7 days
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).
Parent-Infant Interaction Observation (PIIO) Checklist:
Time frame: 7 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- BackgroundGibaud-Wallston J, Wandersman LP. Parenting sense of competence scale. 1978. https://researchingparents.wordpress.com/2013/02/15/parentingsense- of-competence-psoc/
- BackgroundJnaneswari. 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: PubMed 8506163Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
- BackgroundP.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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seham Saleh principal investigator
Matrouh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creating Opportunities for Parent Empowerment (COPE) Program in people with Empowerment and Competence, run by Matrouh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Sense of Competency Scale (PSOC) (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06502730, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.