Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616090
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2023-12-01
Brief Title:
Nurse Implemented Infant-Mother Attachment Security Program
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Effectiveness of Nurse Implemented Attachment-Based Maternal Sensitivity Program in Primary Family Health Care Services
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 eg 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 eg 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 childs emotions and behaviors and psychological characteristics eg 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 programs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None