Integrated Behavioral Health - Prevention for Prevention

Phase-Based Estimates
1
Effectiveness
1
Safety
Cincinnati Childrens Hospital Medical Center, Cincinnati, OH
Integrated Behavioral Health - Prevention - Behavioral
Eligibility
18 - 65
Female
Eligible conditions
Prevention

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.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Integrated Behavioral Health - Prevention will improve 3 primary outcomes, 3 secondary outcomes, and 3 other outcomes in patients with Prevention. Measurement will happen over the course of Baseline.

7-month follow-up
Infant self-regulation
Maternal appraisement of life stress
Maternal feelings of efficacy in infant care
Maternal parenting behaviors
Parental knowledge of child development
Parenting beliefs and practices
Baseline
Maternal experiences of violence and adversity in childhood
Infants' birth through 5-months of age
Health Service Utilization - Immunizations
Infants' birth through 7-months of age
Adherence to well-child visits in first 7 months of life

Trial Safety

Trial Design

2 Treatment Groups

Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition
Integrated Behavioral Health - Prevention (IBH-P)

This trial requires 160 total participants across 2 different treatment groups

This trial involves 2 different treatments. Integrated Behavioral Health - Prevention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Integrated Behavioral Health - Prevention (IBH-P)
Behavioral
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.
Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7-month follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7-month follow-up for reporting.

Closest Location

Cincinnati Childrens Hospital Medical Center - Cincinnati, OH

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
English speaking
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.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is prevention?

Add answer

There are many programs aimed at preventing childhood obesity, in many countries, to reduce the number of cases of chronic diseases such as type-2 diabetes mellitus.

Unverified Answer

What causes prevention?

Add answer

Preventing diseases is an important task for health professionals. It is also a personal challenge for each of us. However, it is not difficult to increase the rate of prevention; instead, it can be done through more effective training in health education in a variety of settings, with support from key stakeholders, particularly policy makers and primary care physicians.

Unverified Answer

How many people get prevention a year in the United States?

Add answer

The numbers of American adults who receive preventive services can be improved by both public and private health programs. The proportion of the adult population receiving each service can be increased.

Unverified Answer

What are common treatments for prevention?

Add answer

Fewer than half (21%) of general practitioner patients thought that the most common treatments for prevention were effective. In a recent study, findings underscore the need for clinicians to discuss and identify the most common treatments and risks of common treatments for protection against disease.

Unverified Answer

What are the signs of prevention?

Add answer

There is a need for health education programmes in the community to raise awareness of the signs of breast cancer in women and cervical cancer in men.

Unverified Answer

Can prevention be cured?

Add answer

The current knowledge of the pathogenic mechanisms of the disease suggests that a better understanding of the mechanisms that control the onset and progression of the disease would enable us to develop effective therapeutic strategies to prevent its onset. Prevention can be accomplished either at an individual level through lifestyle changes, or by providing appropriate preventive interventions by governmental and nongovernmental agencies. The challenge for the future is to identify the genetic and other factors that regulate the onset of the condition and devise effective strategies to alter them prior to symptom development.

Unverified Answer

Does integrated behavioral health - prevention improve quality of life for those with prevention?

Add answer

Findings suggest improvements in most components of QoL among participants in both the BIHPV intervention group and controls. Both groups experienced improvements in mental and physical aspects of QoL after 12 months. Additionally, a significant improvement in mental QoL was seen in the intervention group, indicating additional benefit of BIHPV as a tool for improving mental wellbeing. The improvement in mental QoL was related to improvements in depressive symptoms.

Unverified Answer

Does prevention run in families?

Add answer

These analyses imply that even a modest reduction in risk of developing Alzheimer's disease could have a substantial impact on the number of cases that would be diagnosed; we estimate that approximately 4,000 new cases of Alzheimer's disease would be prevented annually for each 10% reduction in familial transmission rate. Preventing familial Alzheimer disease appears to be a promising strategy for decreasing both the incidence and severity of Alzheimer's disease.

Unverified Answer

What is the latest research for prevention?

Add answer

One [preventive technique] is to reduce the number of cigarette smoking [people] by offering them to stop. This is a common technique being explored [for] [Cancer prevention.] For those who [have already smoking] try to quit the habit. There is also a common technique in [cardiovascular medicine] called stopping at the early stage of heart disease. A patient’s lifestyle can be [improved] by stopping smoking, stopping from binge drinking, giving up junk food, and exercising more. For men who haven’t had an [attempt at stopping smoking].

Unverified Answer

What are the latest developments in integrated behavioral health - prevention for therapeutic use?

Add answer

The current evidence base is fragmented, and as a result, the evidence base will continue to evolve. As treatment options for depression and other anxiety disorders are improved, integrated behavioral health will continue to be one of the most effective practices for treating these conditions in the primary care setting.

Unverified Answer

What is the average age someone gets prevention?

Add answer

Many adolescents believe that the average age to get vaccinations is six. In our cohort, it is actually 16. There may be an opportunity to reach out to teens earlier and to encourage vaccination. The CDC recommends both the measles and mumps and the HPV vaccines to be injected. These injections are at risk of anaphylaxis if not properly administered. To avoid such dangers, the CDC advises health workers to first perform an allergy evaluation and to administer an injection under direct observation by a trained medical professional. Vaccinations must be given in a medical setting and should not be done in the public at large outdoors with minimal protection. There is also a public awareness program for teens about vaccination. Vaccinations for teenagers will likely take the form of the HPV vaccine.

Unverified Answer

Has integrated behavioral health - prevention proven to be more effective than a placebo?

Add answer

This program was significantly more successful in reducing drug-associated hospitalizations and substance-related problems than a control group. This is the first such program in the nation.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Prevention by sharing your contact details with the study coordinator.