Nurse Implemented Infant-Mother Attachment Security Program

NCT06616090 | Not Yet Recruiting

• 1 other identifier: 123K416
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurse's Role; Infant Development; Maternal Behavior

Keywords

attachment-based program; maternal sensitivity; attachment security; nurse-based; primary healthcare

Outcome Measures

Primary Outcomes (5)

• 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

  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).

  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)

  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.

  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.

  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

  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

  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

  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

  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

  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

Study Arms (2)

Nurse implementation

EXPERIMENTAL

This arm will receive nurse implemented attachment-based parenting modules in addition to routine well-child check up

Behavioral: Nurse Implemented Infant-Mother Attachment Security Program

No intervention

NO INTERVENTION

This arm will receive routine well-child check up

Interventions

Nurse Implemented Infant-Mother Attachment Security Program BEHAVIORAL

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.

Nurse implementation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• mothers with 9- to 12-month infants
• having a normally developing infant.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sabanci University: lead

Study Sites (1)

Sabanci University

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Feyza Çorapçı, PhD

  Sabanci University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feyza Çorapçı, PhD

CONTACT

905326768807; feyza.corapci@sabanciuniv.edu

Nebi Sumer, PhD

CONTACT

905324852012; nebi.sumer@sabanciuniv.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment team will be blind to the treatment condition of the mothers.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: September 27, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available in 2027

Locations

TU (1)