Clinical trial NCT03367845: Efficacy of Family Programs for Improving Child and Family Health and Development
Official title: Efficacy of Family Programs for Improving Child and Family Health and Development
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Behavior, Infant
Keywords: Parent sensitivity
Fathers
Attachment
Marital communication
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-12-11
Enrollment: 1005
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 X 2 factorial design testing two different interventions
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Parents cohabiting
* Both mothers and fathers agree to participate
* Healthy infants with no known health problems

Exclusion Criteria:

* Discovery of developmental delays or health problems in infants

Primary outcomes:
measure: Change in Parental Sensitivity
timeFrame: 12-months
measure: Change in Child Care Activities Scale
timeFrame: 12-months
measure: Change in Parenting Stress Index - Short Form Version III
timeFrame: 12 months
measure: Change in Parenting Sense of Competence Scale
timeFrame: 12-months
measure: Change in Spousal Attachment Questionnaire
timeFrame: 12-months
measure: Change in Conflict and Problem Solving Scale
timeFrame: 12-months
measure: Change in O'Leary Porter Scale
timeFrame: 12-months
measure: Change in Brief Infant Toddler Emotional Assessment
timeFrame: 12-months
measure: Mother-Infant Attachment
timeFrame: 12 months
measure: Father-Infant Attachment
timeFrame: 10 months
measure: Change in Couples' communication styles
timeFrame: 12-months
measure: Change in Infant Affect Regulation
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Fort Wayne Center for Children and Families
state: Indiana
city: South Bend
country: United States
facility: William J. Shaw Center for Children and Families
state: Indiana
Study officials:
affiliation: Colorado State University
name: Julia Braungart-Rieker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Notre Dame
name: E M Cummings, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: