Nurse's RoleNCT06616090
Nurse Implemented Infant-Mother Attachment Security Program
A study testing Nurse Implemented Infant-Mother Attachment Security Program in people with Nurse's Role and Infant Development, run by Sabanci University at 1 site in Turkey (Türkiye).
Trial summary
This study focuses on adapting and evaluating an attachment-based intervention program implemented by nurses in Family Health Centers (FHCs) in Turkey. The program aims to enhance parental sensitivity and infant-mother attachment security. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Infant Development, Maternal Behavior
- What is being tested?
- Nurse Implemented Infant-Mother Attachment Security Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- mothers with 9- to 12-month infants
- having a normally developing infant.
Who cannot join
- mothers with infants who have a chronic pediatric health problem
- mother with infants whose developmental problems are detected during routine evaluations
- mothers with temporary protection status (i.e., immigrants) due to potential communication problems
- if the mother is not the primary caregiver
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sabanci University
Istanbul
Feyza Çorapçı, PhD, 905326768807, feyza.corapci@sabanciuniv.edu
Nebi Sumer, PhD, 905324852012, nebi.sumer@sabanciuniv.edu
About this study
Official title: Investigating the Effectiveness of Nurse Implemented Attachment-Based Maternal Sensitivity Program in Primary Family Health Care Services
This study focuses on adapting and evaluating an attachment-based intervention program implemented by nurses in Family Health Centers (FHCs) in Turkey. The program aims to enhance parental sensitivity and infant-mother attachment security. Evidence suggests that such programs, developed in Western countries, effectively improve parenting behaviors and attachment quality. Despite the positive effects of similar programs in Turkey, their integration into primary healthcare for wider public benefit remains unexplored. The project will develop an intervention protocol based on effective methods from previous attachment-based programs into routine childcare visits at FHCs. A randomized controlled trial involving 120 mothers with 9- to 12-month-old babies in Istanbul will be recruited. FHCs will be randomly assigned to intervention and control groups, with 60 mother-infant dyads in each condition. Nurses will deliver the program during childcare visits at 9, 12, 15, and 18 months. Intervention FHCs will also use reminders like posters and short films in the waiting rooms to reinforce the concepts. Effectiveness will be evaluated through pretest, posttest, and follow-up home visits using observational and self-report measures on attachment security, maternal sensitivity, as well as maternal psychological characteristics, along with infant socioemotional measures. Upon completion of the project, control FHC nurses will receive training to deliver a condensed version of the program.
Read the detailed description
This study aims to adapt and evaluate the effectiveness of an attachment-based, protective-preventive intervention program implemented by nurses in Family Health Centers (FHC) that routinely follow up infants' health. Attachment-based parenting intervention programs have been developed and implemented in Western countries given that parental sensitivity and secure attachment relationship in the early years are critical precursors of psychological resilience. These evidence-based programs have been widely shown to reinforce responsive parenting behaviors and improve attachment quality. A few attachment-based programs have been adopted in Turkey with documented positive effects. However, adaptations of such programs within the primary healthcare services that actively reach families have yet to be conducted to evaluate their potential widespread use for public benefit. In this proposed project, effective application methods of attachment-based programs identified in previous studies, will be integrated to the current well-child care visits in FHCs. It is expected that this program will positively affect maternal sensitivity, caregiving competence, positive discipline methods, mother-child attachment security, and reduce child problem behaviors (e.g., internalizing and externalizing problems). It is also expected that the program effectiveness will be more robust among mothers from socioeconomically disadvantaged families, those with initially low levels of sensitivity, and anxious attachment pattern. To test these expectations with a randomized controlled trial, 120 mothers with 9-month-old babies from FHCs in Istanbul will participate. Selected FHCs will be randomly assigned to intervention and control conditions. Mother-infant dyads will be divided into intervention (N = 60) and control (N = 60) groups. Following a comprehensive training, nurses will apply five modules with sensitivity and positive discipline themes, including a booster module, to the mother-infant dyads during well-child care visits at the 9th, 12th, 13th, 14th and 15th months following the pretest measurements. The application will draw on nurses' positive feedback to mothers utilizing short video recordings and in-the-moment mother-baby interactions consistent with each module theme. Additionaly, mothers will be exposed to the reminders (e.g., pictures, posters, short film screenings) reflecting maternal sensitivity and secure attachment in the waiting rooms of the intervention FHCs. The proposed project will be carried out by experts from psychology with research and experience in attachment-based intervention in collaboration with the experts working in family medicine, nursing, and primary healthcare. To examine program effectiveness, pretest, posttest, and follow-up measurements will occur at pre-defined times through home visits to mothers. Data on mother and infant demographics and psychological characteristics will be collected using multimethod measurement in line with the program goals. Thus, maternal sensitivity level will be assessed using the Ainsworth Sensitivity Scale and Maternal Sensitivity Q-Sort, and the mother-infant attachment quality will be assessed using the short form of the Attachment Q-Sort. Besides observation, mother-reported sensitivity and attitudes towards discipline, caregiving competence, mental processes underlying child's emotions and behaviors, and psychological characteristics (e.g., adult attachment pattern, depressive symptoms) will be evaluated with widely used measurement tools. Finally, infant development and temperament will be assessed via mother report. Following the intervention program, training will also be given to nurses in the control FHCs, who will deliver a condensed maternal sensitivity program to control mothers. The program will be disseminated to relevant experts and institutions, including the priority stakeholders in the family primary healthcare system. If the program's effectiveness is demonstrated, special efforts will be made to scale-up the program. Given that attachment-based early intervention programs positively affect child development throughout life, improve the family environment and social relations and reduce public expenditure on health problems in the long run, the proposed program is expected to create a similar impact in Turkey and lead to positive psychosocial change.
- Conditions
- Nurse's Role, Infant Development, Maternal Behavior
- Being tested
- Nurse Implemented Infant-Mother Attachment Security Program
- Keywords
- attachment-based program, maternal sensitivity, attachment security, nurse-based, primary healthcare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Implemented Infant-Mother Attachment Security ProgramBehavioural
The intervention will draw on video-feedback of mother-infant interactions during the well-child visit. Nurses will videotape the dyad during routine visit in the Family Health Center and show short clips to mothers during the session in order to provide mother positive feedback on their sensitive caregiving. Additionaly, intervention mothers will be exposed to the reminders (e.g., pictures, posters, short film screenings) reflecting maternal sensitivity and secure attachment in the waiting rooms of the intervention Family Health Centers.
| Study group | Role | What they receive |
|---|---|---|
| Nurse implementation | Experimental | This arm will receive nurse implemented attachment-based parenting modules in addition to routine well-child check up Receives: Behavioral: Nurse Implemented Infant-Mother Attachment Security Program |
| No intervention | No intervention | This arm will receive routine well-child check up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal sensitivity 1
The Ainsworth Sensitivity Scale (Ainsworth et al., 1978) will be used to assess maternal global sensitivity. The scale ranges from 1 to 7, with higher scores meaning higher maternal sensitivity
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal sensitivity 2
Maternal Behavior Q-set will be used to assess maternal global sensitivity. The score ranges from -1 (extremely insensitive) to +1 (extremely sensitive).
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Attachment Security
Attachment Q-sort will be used to assess the security of infant attachment. Scores range from -1 (high levels of attachment insecurity) to +1 (high levels of attachment security)
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal Sensitive Discipline
Maternal Attitudes toward Sensitivity and Sensitive Discipline Scale will be used. The scale score ranges from 1 to 6. Higher scores characterize mothers with more sensitive attitudes towards sensitive care and discipline.
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Infant Socio-Emotional Development
The Problem Behaviors Subscale of the Brief Infant Toddler Socioemotional Assessment scale will be used to measure age-relevant developmental difficulties in young children. Scores range from 0 to 62, with higher scores characterizing children with more frequent behavioral and emotional problems.
Measured: Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Secondary outcomes (6)
Maternal Reflective Functioning
Mothers\' ability to mentalize their children will be measured with the Pre-Mentalizing Modes of the Parental Reflective Functioning Questionnaire. Scores range from 1 to 7. Higher scores indicate higher levels of impairment in parental reflective functioning such as parents' lack of acknowledgement for the child's subjective world.
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal Attachment Representation
The short form of the Experiences in Close Relationships questionnaire will be used to measure mothers\' attachment anxiety and avoidance. Scores for attachment anxiety range from 1 to 6, with higher scores indicating higher levels of attachment anxiety in mothers. Scores for attachment avoidance range from 1 to 6, with higher scores indicating higher levels of attachment avoidance in mothers.
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal Efficacy in Parenting
Mothers\' sense of competence in dealing with infant care and parenting will be measured with a subscale from the Parenting Stress Index. The scores range from 1 to 6, with higher scores higher perceived competence in parenting.
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal depression
Maternal psychological well being will be measured by using the Edinburgh Postpartum Depression scale. The scores range from 0 to 30 with higher scores indicating higher levels of maternal depression
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
General Parenting Practices
Maternal warmth, cognitive stimulation and general discipline practices will be measured with the Comprehensive Early Childhood Parenting Questionnaire. Scores range from 1 to 6 with higher scores indicating better quality caregiving.
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Marital Conflict
Spousal disagreement over child rearing will be measured with the O\'Leary-Porter scale of marital conflict. Scores range from 1 to 4, with higher scores indicating more frequent spousal disagreement in front of the child.
Measured: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial will be conducted. The sample will consist of 120 mothers with 9- to 12-month-old babies from Family Health Centers (FHC) in Istanbul. FHCs will be randomly assigned to intervention and control conditions so that mother-infant dyads will be divided into intervention (N = 60) and control (N = 60) groups. A comprehensive training will be provided to intervention nurses. Mother-infant dyads in the intervention group will receive the regulare well child check up procedures along with the attachment-based intervention modules, following the pretest measurements. Mother-infant dyads in the control group will receive the routine well-child check up procedures. Changes in maternal sensitivity and infant attachment security from pre- to posttest will be compared across two groups measures. Control mothers will receive a condensed form of the intervention after the follow up assessments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sabanci University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Corapcı, Sabanci University
- Investigators
- Feyza Çorapçı, PhD, Principal investigator, Sabanci University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616090
- Sponsor's protocol ID
- 123K416
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open science guidelines will be followed
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Nurse Implemented Attachment-Based Maternal Sensitivity Program in Primary Family Health Care Services
- ClinicalTrials.gov ID
- NCT06616090
- Acronym / sponsor ID
- 123K416
- Conditions
- Nurse's Role, Infant Development, Maternal Behavior
- Keywords
- attachment-based program, maternal sensitivity, attachment security, nurse-based, primary healthcare
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sabanci UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Sep 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.
This study focuses on adapting and evaluating an attachment-based intervention program implemented by nurses in Family Health Centers (FHCs) in Turkey. The program aims to enhance parental sensitivity and infant-mother attachment security. Evidence suggests that such programs, developed in Western countries, effectively improve parenting behaviors and attachment quality. Despite the positive effects of similar programs in Turkey, their integration into primary healthcare for wider public benefit remains unexplored. The project will develop an intervention protocol based on effective methods from previous attachment-based programs into routine childcare visits at FHCs. A randomized controlled trial involving 120 mothers with 9- to 12-month-old babies in Istanbul will be recruited. FHCs will be randomly assigned to intervention and control groups, with 60 mother-infant dyads in each condition. Nurses will deliver the program during childcare visits at 9, 12, 15, and 18 months. Intervention FHCs will also use reminders like posters and short films in the waiting rooms to reinforce the concepts. Effectiveness will be evaluated through pretest, posttest, and follow-up home visits using observational and self-report measures on attachment security, maternal sensitivity, as well as maternal psychological characteristics, along with infant socioemotional measures. Upon completion of the project, control FHC nurses will receive training to deliver a condensed version of the program.
Detailed description
This study aims to adapt and evaluate the effectiveness of an attachment-based, protective-preventive intervention program implemented by nurses in Family Health Centers (FHC) that routinely follow up infants' health. Attachment-based parenting intervention programs have been developed and implemented in Western countries given that parental sensitivity and secure attachment relationship in the early years are critical precursors of psychological resilience. These evidence-based programs have been widely shown to reinforce responsive parenting behaviors and improve attachment quality. A few attachment-based programs have been adopted in Turkey with documented positive effects. However, adaptations of such programs within the primary healthcare services that actively reach families have yet to be conducted to evaluate their potential widespread use for public benefit. In this proposed project, effective application methods of attachment-based programs identified in previous studies, will be integrated to the current well-child care visits in FHCs. It is expected that this program will positively affect maternal sensitivity, caregiving competence, positive discipline methods, mother-child attachment security, and reduce child problem behaviors (e.g., internalizing and externalizing problems). It is also expected that the program effectiveness will be more robust among mothers from socioeconomically disadvantaged families, those with initially low levels of sensitivity, and anxious attachment pattern. To test these expectations with a randomized controlled trial, 120 mothers with 9-month-old babies from FHCs in Istanbul will participate. Selected FHCs will be randomly assigned to intervention and control conditions. Mother-infant dyads will be divided into intervention (N = 60) and control (N = 60) groups. Following a comprehensive training, nurses will apply five modules with sensitivity and positive discipline themes, including a booster module, to the mother-infant dyads during well-child care visits at the 9th, 12th, 13th, 14th and 15th months following the pretest measurements. The application will draw on nurses' positive feedback to mothers utilizing short video recordings and in-the-moment mother-baby interactions consistent with each module theme. Additionaly, mothers will be exposed to the reminders (e.g., pictures, posters, short film screenings) reflecting maternal sensitivity and secure attachment in the waiting rooms of the intervention FHCs. The proposed project will be carried out by experts from psychology with research and experience in attachment-based intervention in collaboration with the experts working in family medicine, nursing, and primary healthcare. To examine program effectiveness, pretest, posttest, and follow-up measurements will occur at pre-defined times through home visits to mothers. Data on mother and infant demographics and psychological characteristics will be collected using multimethod measurement in line with the program goals. Thus, maternal sensitivity level will be assessed using the Ainsworth Sensitivity Scale and Maternal Sensitivity Q-Sort, and the mother-infant attachment quality will be assessed using the short form of the Attachment Q-Sort. Besides observation, mother-reported sensitivity and attitudes towards discipline, caregiving competence, mental processes underlying child's emotions and behaviors, and psychological characteristics (e.g., adult attachment pattern, depressive symptoms) will be evaluated with widely used measurement tools. Finally, infant development and temperament will be assessed via mother report. Following the intervention program, training will also be given to nurses in the control FHCs, who will deliver a condensed maternal sensitivity program to control mothers. The program will be disseminated to relevant experts and institutions, including the priority stakeholders in the family primary healthcare system. If the program's effectiveness is demonstrated, special efforts will be made to scale-up the program. Given that attachment-based early intervention programs positively affect child development throughout life, improve the family environment and social relations and reduce public expenditure on health problems in the long run, the proposed program is expected to create a similar impact in Turkey and lead to positive psychosocial change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial will be conducted. The sample will consist of 120 mothers with 9- to 12-month-old babies from Family Health Centers (FHC) in Istanbul. FHCs will be randomly assigned to intervention and control conditions so that mother-infant dyads will be divided into intervention (N = 60) and control (N = 60) groups. A comprehensive training will be provided to intervention nurses. Mother-infant dyads in the intervention group will receive the regulare well child check up procedures along with the attachment-based intervention modules, following the pretest measurements. Mother-infant dyads in the control group will receive the routine well-child check up procedures. Changes in maternal sensitivity and infant attachment security from pre- to posttest will be compared across two groups measures. Control mothers will receive a condensed form of the intervention after the follow up assessments.
| Arm | Type | Receives |
|---|---|---|
| Nurse implementation | Experimental | Behavioral: Nurse Implemented Infant-Mother Attachment Security ProgramThis arm will receive nurse implemented attachment-based parenting modules in addition to routine well-child check up |
| No intervention | No intervention | –This arm will receive routine well-child check up |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- mothers with 9- to 12-month infants
- having a normally developing infant.
Key exclusion criteria (4 listed)
- mothers with infants who have a chronic pediatric health problem
- mother with infants whose developmental problems are detected during routine evaluations
- mothers with temporary protection status (i.e., immigrants) due to potential communication problems
- if the mother is not the primary caregiver
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 |
|---|---|---|
| Nurse Implemented Infant-Mother Attachment Security ProgramThe intervention will draw on video-feedback of mother-infant interactions during the well-child visit. Nurses will videotape the dyad during routine visit in the Family Health Center and show short clips to mothers during the session in order to provide mother positive feedback on their sensitive caregiving. Additionaly, intervention mothers will be exposed to the reminders (e.g., pictures, posters, short film screenings) reflecting maternal sensitivity and secure attachment in the waiting rooms of the intervention Family Health Centers. | Behavioural | Nurse implementation |
Primary outcome
Maternal sensitivity 1
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
The Ainsworth Sensitivity Scale (Ainsworth et al., 1978) will be used to assess maternal global sensitivity. The scale ranges from 1 to 7, with higher scores meaning higher maternal sensitivity
Maternal sensitivity 2
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal Behavior Q-set will be used to assess maternal global sensitivity. The score ranges from -1 (extremely insensitive) to +1 (extremely sensitive).
Attachment Security
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Attachment Q-sort will be used to assess the security of infant attachment. Scores range from -1 (high levels of attachment insecurity) to +1 (high levels of attachment security)
Maternal Sensitive Discipline
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal Attitudes toward Sensitivity and Sensitive Discipline Scale will be used. The scale score ranges from 1 to 6. Higher scores characterize mothers with more sensitive attitudes towards sensitive care and discipline.
Infant Socio-Emotional Development
Time frame: Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
The Problem Behaviors Subscale of the Brief Infant Toddler Socioemotional Assessment scale will be used to measure age-relevant developmental difficulties in young children. Scores range from 0 to 62, with higher scores characterizing children with more frequent behavioral and emotional problems.
6 secondary outcomes
Maternal Reflective Functioning
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal Attachment Representation
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal Efficacy in Parenting
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Maternal depression
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
General Parenting Practices
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Marital Conflict
Time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Yes. Open science guidelines will be followed
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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.
Feyza Çorapçı, PhD principal investigator
Sabanci 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 Nurse Implemented Infant-Mother Attachment Security Program in people with Nurse's Role and Infant Development, run by Sabanci University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Sep 2024. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feyza Çorapçı, PhD (905326768807, feyza.corapci@sabanciuniv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal sensitivity 1 (time frame: Pretest: 1 month before the intervention begins when infants are 8 months old. Posttest: Immediately after the intervention concludes, when infants are 18 months old. Follow-up: 2 months after the the intervention ends, when infants are 20 months old). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2024.