Efficacy of Family Programs for Improving Child and Family Health and Development

NCT03367845 | Active Not Recruiting

• 2 other identifiers: NotreDameR01HD087319
• Study Type: interventional
• Target: 1,005
• Locations: 1 country
• Sites: 2

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.

Conditions

Behavior, Infant

Keywords

Parent sensitivity; Fathers; Attachment; Marital communication

Outcome Measures

Primary Outcomes (12)

• Change in Parental Sensitivity

  Observational measure of parent sensitivity during infant-parent interactions

  12-months

• Change in Child Care Activities Scale

  Parent-report questionnaire assessing degree of involvement with infants at home, reflecting percent time engaging in each activity. Subscales include: Direct Care, Indirect Care, Play Activities, and Total score all ranging from 0 - 100. Higher values mean higher percentage of time spent in that caretaking activity. Scores are averaged to create the subscales and total score.

  12-months

• Change in Parenting Stress Index - Short Form Version III

  Parent-report questionnaire assessing degree of stress about roles as a parent. Subscales include: Parental Distress (scale range from 5 - 60; 33 and higher = 85th percentile); Parent-Child Dysfunctional Interaction (scale range 5 - 60; 26 and higher = 85th percentile); Difficult Child (scale range 5 - 60; 33 and higher = 85th percentile); Total Score (scale range 15 - 180; 86 and higher = 85th percentile). Higher values mean greater levels of parenting stress. Scores are summed to create subscales and the total score.

  12 months

• Change in Parenting Sense of Competence Scale

  Parent-report measure of self-efficacy in their role as a parent. Subscales include Satisfaction (cale range 9 - 54); Efficacy (scale range 8 - 48). Total Score (scale range 17 - 102). Higher values indicate a greater satisfaction, efficacy, and total sense of competence. Scores are summed to create the subscales and total score.

  12-months

• Change in Spousal Attachment Questionnaire

  Parent report questionnaire assessing parents' security in their relationships with each other. Subscales include Preoccupied Attachment (scale range 1 - 7); Fearful Attachment (scale range 1 - 7); Secure Attachment (scale range 1 - 7). Higher values mean greater levels of that type of attachment to spouse. Scores are averages of item sets.

  12-months

• Change in Conflict and Problem Solving Scale

  Parent report questionnaire assessing conflict strategies in spousal relationship. Subscales include Cooperation (scale range 0 - 36); Avoidance and Capitulation (scale range 0 - 60); Stonewalling (scale range 0 - 42); Verbal Aggression (scale range 0 - 48); Physical Aggression (scale range 0 - 42); Child Involvement (scale range 0 - 30); Conflict Resolution (scale range 0 - 39). Higher scores indicate greater levels of use of conflict strategies or greater resolution. Item sets are summed to create subscale scores.

  12-months

• Change in O'Leary Porter Scale

  Parent report questionnaire assessing children's exposure to marital conflict. There is a total score (scale range 0 - 36). Higher values indicate more conflict. Items are summed to create the total score.

  12-months

• Change in Brief Infant Toddler Emotional Assessment

  Parent questionnaire evaluating children's behavior problems and competence. Subscales include Problems (scale range 0 - 66); Competencies (scale range 0 - 22); Externalizing problems (scale range 0 - 12); Internalizing (scale range 0 - 16); Dysregulation (scale range 0 - 16); Autism Spectrum Disorder (scale range 0 - 17). Higher scores indicate higher levels of each construct or higher screening value for Autism Spectrum Disorder. Scores are summed.

  12-months

• Mother-Infant Attachment

  Observational ratings of infant attachment security with mothers from the Strange Situation; with COVID-19, we no longer do in-person assessments so we now use a modified version of the Attachment Q-Sort which is an interview with mothers over zoom.

  12 months

• Father-Infant Attachment

  Observational ratings of infant attachment security with fathers from the Strange Situation; with COVID-19, we no longer do in-person assessments so we now use a modified version of the Attachment Q-Sort which is an interview with fathers over zoom.

  10 months

• Change in Couples' communication styles

  Observational measure of parents' conflict styles during discussions

  12-months

• Change in Infant Affect Regulation

  Observational measure of infants' affective and regulatory behaviors during parent-child interactions and during couples' discussions

  12-months

Study Arms (4)

Control

EXPERIMENTAL

Phone contacts with content not focusing on sensitivity or couples' relationships

Behavioral: Control

Sensitivity Intervention

EXPERIMENTAL

Home visits to enhance mother-infant and father-infant parental sensitivity; with COVID-19, we now conduct remote visits using Zoom

Behavioral: Sensitivity Intervention

Couples Intervention

EXPERIMENTAL

Home visits to enhance constructive couples' communication; with COVID-19, we now conduct remote visits using Zoom

Behavioral: Couples' Intervention

Sensitivity and Couples Intervention

EXPERIMENTAL

Home visits combining sensitivity and couples' interventions; with COVID-19, we now conduct remote visits using Zoom

Behavioral: Sensitivity and Couples' Intervention

Interventions

Control BEHAVIORAL

Parents receive 8 phone contacts (1 per week) that do not focus on material in the sensitivity and couples communication intervention.

Control

Sensitivity Intervention BEHAVIORAL

4 home visits take place. Mothers and fathers are video recorded with their infant (separately) for approximate 10-15 minutes at the beginning of each visit. The recorded situations are natural (e.g., playing together, bathing the baby, mealtime, etc.) and the family coach (interventionist) is not actively involved in the parent-child interaction. A different theme is covered across the four intervention sessions. For each parent-infant interaction recording, the family coach reviews the recordings between visits and provides feedback to parents in the following intervention session. The exception to this is that video of parent-child interactions during the lab pre-test is used for material at the first home visit. Each session takes approximately 90 minutes. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom.

Also known as: Videofeedback to Promote Positive Parenting

Sensitivity Intervention

Couples' Intervention BEHAVIORAL

The psycho-educational inter-parental conflict prevention curriculum is a 4-session program that takes place in the families' homes. Each session lasts approximately 90 minutes and involves discussion and practice of four themes pertinent to improving conflict process, communication, and emotional security in the family: Conflict Overview, Interparental Conflict and Children, Stresses of Parenting, and Emotional Security. The family coach scaffolds and supports the couples' development of constructive conflict behaviors. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom.

Couples Intervention

Sensitivity and Couples' Intervention BEHAVIORAL

This group receives both the Sensitivity and Couples' Intervention in their home. There are 8 home visits (4 for Sensitivity and 4 for Couples Intervention). Because of COVID-19, we now conduct remote visits using Zoom.

Sensitivity and Couples Intervention

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Discovery of developmental delays or health problems in infants

Sponsors & Collaborators

• University of Notre Dame: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Fort Wayne Center for Children and Families

Fort Wayne, Indiana, 46814, United States

Location

William J. Shaw Center for Children and Families

South Bend, Indiana, 46535, United States

Location

MeSH Terms

Conditions

Infant Behavior

Interventions

Sensitivity and Specificity

Condition Hierarchy (Ancestors)

Child Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Statistics as Topic; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Julia Braungart-Rieker, Ph.D.

  Colorado State University

  PRINCIPAL INVESTIGATOR

• E M Cummings, Ph.D.

  University of Notre Dame

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care Providers and Assessors represent two different teams of staff. Each is blind to the other status (how families did during assessment and which group families are assigned to). They do not have access to each others' files.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head

Model Details: 2 X 2 factorial design testing two different interventions

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 11, 2017
• Study Start: January 11, 2017
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)