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Integrated Behavioral Health - Prevention for Prevention

N/A
Waitlist Available
Led By Robert T Ammerman, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biological mother of a newborn infant presenting at the newborn well-child visit
Intends to continue to receive infant's pediatric care at one of the three participating clinics over the next year.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-month follow-up
Awards & highlights

Study Summary

This study is evaluating whether a universal prevention program delivered by psychologists in conjunction with pediatric primary care well-child visits is acceptable and effective.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Infant self-regulation
Maternal parenting behaviors
Parental knowledge of child development
Secondary outcome measures
Maternal appraisement of life stress
Maternal feelings of efficacy in infant care
Parenting beliefs and practices
Other outcome measures
Adherence to well-child visits in first 7 months of life
Health Service Utilization - Immunizations
Maternal experiences of violence and adversity in childhood

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Behavioral Health - Prevention (IBH-P)Experimental Treatment1 Intervention
The IBH-P intervention addresses four areas: 1) assessment of emotional and behavioral adjustment, 2) parental education on important supports for emotional and behavioral health, 3) modeling and guidance on nurturing and responsive parenting, and 4) addressing parental concerns about and promoting child self-regulation. The primary focus of IBH-P is promoting infant self-regulation by teaching mothers how to soothe and calm their baby. Trauma-informed and relationship building methods are emphasized to acknowledge maternal experiences with violence and adversity and the desire to establish a strong working alliance. IBH-P is distinguished from Bright Futures through its emphasis on experiential learning, modeling of effective parenting skills, in-session practice and feedback, and proactive problem-solving. Families in IBH-P will receive all standard care elements of the well-child visit including pediatrician implementation of Bright Futures curriculum.
Group II: Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th EditionActive Control1 Intervention
The Bright Futures control condition consists of standard of care in addressing emotional and behavioral health as provided by pediatricians. Pediatricians will follow the 4th edition of the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents [pocket guide]. Guidelines are provided for topics to discuss and anticipatory guidance at each well-child visit. In contrast to IBH-P, there is an emphasis on didactic presentation, teaching mothers about developmental milestones, and responding to questions and concerns. These include discussions of crying, soothing, and feeding, although self-regulation is not a unifying theme.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Integrated Behavioral Health - Prevention
2021
N/A
~160

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
814 Previous Clinical Trials
6,531,421 Total Patients Enrolled
Robert T Ammerman, PhDPrincipal InvestigatorCincinnati Children's Hospital Medical Center Cincinnati, OH USA

Frequently Asked Questions

~41 spots leftby Mar 2025