NCT03367845|Active Not Recruiting
Loading search results
Sponsor study identifier
Secondary identifiers
NIH
interventional
1,005
1 country
2
Study Start
January 11, 2017
Actual (reported)Primary Completion
January 30, 2023
Actual (reported)Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 11, 2017
Actual (reported)November 14, 2017
Actual (reported)December 11, 2017
Actual (reported)January 30, 2023
Actual (reported)June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Phone contacts with content not focusing on sensitivity or couples' relationships
Home visits to enhance mother-infant and father-infant parental sensitivity; with COVID-19, we now conduct remote visits using Zoom
Home visits to enhance constructive couples' communication; with COVID-19, we now conduct remote visits using Zoom
Parents receive 8 phone contacts (1 per week) that do not focus on material in the sensitivity and couples communication intervention.
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.
Fort Wayne Center for Children and Families
Fort Wayne, Indiana, 46814, United States
William J. Shaw Center for Children and Families
South Bend, Indiana, 46535, United States
Samantha Murray-Perdue, Ph.D.
Colorado State University
E M Cummings, Ph.D.
University of Notre Dame
1,005 participants (actual enrollment reported by the registry).
First Submitted
November 14, 2017
First Posted
December 11, 2017
Infant-Directed Singing for At-Risk Mothers and Infants
Healthcare Provider Behavior and Children's Perioperative Distress
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
Home visits combining sensitivity and couples' interventions; with COVID-19, we now conduct remote visits using Zoom
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
January 11, 2017
Actual (reported)Primary Completion
January 30, 2023
Actual (reported)Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 1, 2026
Record last verified: 2026-06
At the close of the study, subject data will be deidentified and individual participant data will no longer be available for further use.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: