Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03367845 |
Other study ID # |
NotreDame |
Secondary ID |
R01HD087319 |
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 11, 2017 |
Est. completion date |
March 31, 2024 |
Study information
Verified date |
November 2023 |
Source |
University of Notre Dame |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The proposed research is relevant to public health because of the critical importance of
infant attachment and early experiences to the lifetime trajectory of mental health and
socio-emotional functioning. This Randomized Clinical Trial addresses major gaps in available
family-wide programs that can promote healthy development that best serve infants, mothers,
fathers, and inter-parental relationships in cost-effective ways. This study also
systematically tests for which families the interventions are most effective and rigorously
tests the theoretical processes that link changes in mother-infant, father-infant, and
mother-father interactions with infant and parent outcomes.
Description:
Preventative interventions involving video-feedback programs to promote parenting (VIPP) have
been shown to be successful in improving maternal sensitivity and infant-mother attachment
security. However, interventions might be substantially more effective if broader elements of
family systems were also addressed, including father-child and inter-parental relationships,
particularly given the growing body of evidence that highlights the importance of father
involvement and positive engagement in children's socio-emotional development. Infancy is a
particularly sensitive and vulnerable period not only for the child but also for the parents
who often experience heightened daily stress, parenting demands, work-family role strain, and
inter-parental discord associated with changes in the family.The proposed longitudinal study
addresses major gaps by testing the effectiveness of family-wide preventative interventions
designed to promote healthy development and functioning in infants, mothers, and fathers,
including low-income families. This three-phase study involves a rigorous randomized clinical
trial (RCT) approach and will involve a demographically diverse sample of 400 families. Phase
I involves a lab and home pre-test (infants 6 months of age) and 8-week intervention period;
Phase II (12 months) includes an initial post-test, and Phase III (16-18 months) involves a
second post-test. Families will be randomly assigned to one of four conditions: sensitivity
intervention (SI), couples intervention (CI), both (SI + CI) or control. Specific aims of the
study include: (1) An evaluation of the effectiveness of the SI, CI, and SI+CI interventions
at improving parental sensitivity, parental efficacy, parenting stress, inter-parental
conflict, infant affective development, attachment security, behavior problems, and
socio-emotional competence; (2) A test of the mechanisms through which change in behavior
occurs. For example, relations between SI participation in Phase I and child attachment in
Phase III may be mediated by enhanced parent sensitivity in Phase II.
Relations between CI participation and child outcomes may be mediated by inter-parental
functioning and more effective communication skills; (3) An examination of factors that
moderate the effectiveness of the interventions, determining which families benefit the most.
Potential moderators include demographic characteristics, family (dis)organization, parents'
own caregiving history, parents' depressive and anxious systems, and infant negative
temperament; (4) Mother-father comparisons on direct effects, mediating mechanisms and
moderating processes. This study builds upon past research towards increasing children's
emotional security in multiple family relationships by testing new directions in preventative
interventions in infancy, addressing the mother-child, father-child, and mother-father
relationships. The goal is to foster children's socio-emotional development and security
through cost-effective family-wide interventions in infancy that promote sensitive
parent-infant interactions and improved inter-parental communication.