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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03367845
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Julia Braungart-Rieker, University of Notre Dame

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.

Condition or disease Intervention/treatment Phase
Behavior, Infant Behavioral: Control Behavioral: Sensitivity Intervention Behavioral: Couples' Intervention Behavioral: Sensitivity and Couples' Intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2 X 2 factorial design testing two different interventions
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
Official Title: Efficacy of Family Programs for Improving Child and Family Health and Development
Actual Study Start Date : January 11, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: Control
Phone contacts with content not focusing on sensitivity or couples' relationships
Behavioral: Control
Parents receive 8 phone contacts (1 per week) that do not focus on material in the sensitivity and couples communication intervention.

Experimental: Sensitivity Intervention
Home visits to enhance mother-infant and father-infant parental sensitivity
Behavioral: Sensitivity Intervention
Four 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: Exploration vs. Attachment Behavior, Speaking for the Child, Sensitivity Chain, and Sharing Emotions. 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.
Other Name: Videofeedback to Promote Positive Parenting

Experimental: Couples Intervention
Home visits to enhance constructive couples' communication
Behavioral: Couples' Intervention
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.

Experimental: Sensitivity and Couples Intervention
Home visits combining sensitivity and couples' interventions
Behavioral: Sensitivity and Couples' Intervention
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).

Primary Outcome Measures :
  1. Change in Parental Sensitivity [ Time Frame: 12-months ]
    Observational measure of parent sensitivity during infant-parent interactions

  2. Change in Child Care Activities Scale [ Time Frame: 12-months ]
    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.

  3. Change in Parenting Stress Index - Short Form Version III [ Time Frame: 12 months ]
    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.

  4. Change in Parenting Sense of Competence Scale [ Time Frame: 12-months ]
    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.

  5. Change in Spousal Attachment Questionnaire [ Time Frame: 12-months ]
    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.

  6. Change in Conflict and Problem Solving Scale [ Time Frame: 12-months ]
    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.

  7. Change in O'Leary Porter Scale [ Time Frame: 12-months ]
    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.

  8. Change in Brief Infant Toddler Emotional Assessment [ Time Frame: 12-months ]
    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.

  9. Mother-Infant Attachment [ Time Frame: 12 months ]
    Observational ratings of infant attachment security with mothers from the Strange Situation

  10. Father-Infant Attachment [ Time Frame: 10 months ]
    Observational ratings of infant attachment security with fathers from the Strange Situation

  11. Change in Couples' communication styles [ Time Frame: 12-months ]
    Observational measure of parents' conflict styles during discussions

  12. Change in Infant Affect Regulation [ Time Frame: 12-months ]
    Observational measure of infants' affective and regulatory behaviors during parent-child interactions and during couples' discussions

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03367845

Contact: Cheryl Lee, MA 5746310950

United States, Indiana
Fort Wayne Center for Children and Families Recruiting
Fort Wayne, Indiana, United States, 46814
Contact: Kathleen Bergman, PhD    616-481-2742   
William J. Shaw Center for Children and Families Recruiting
South Bend, Indiana, United States, 46535
Contact: Terri Sweeney, BA    574-631-0959   
Sponsors and Collaborators
University of Notre Dame
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Julia Braungart-Rieker, Ph.D. University of Notre Dame

Responsible Party: Julia Braungart-Rieker, Professor, University of Notre Dame Identifier: NCT03367845     History of Changes
Other Study ID Numbers: NotreDame
R01HD087319 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At the close of the study, subject data will be deidentified and individual participant data will no longer be available for further use.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Julia Braungart-Rieker, University of Notre Dame:
Parent sensitivity
Marital communication