Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants

Prevention Clinical Trial

Official title:

Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825210
• Other study ID #: 2020-1007
• Status: Completed
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: August 24, 2022

Study information

• Verified date: September 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the acceptability and preliminary efficacy of a universal prevention program delivered by psychologists in conjunction with pediatric primary care well-child visits.

Description:

Integrated behavioral health has emerged as an effective approach to addressing emotional and behavioral health needs of children in the pediatric setting, yet there is little evidence for a standardized model of care for providing universal preventive services in pediatric primary care. Current models are typically loosely constructed, inconsistently applied, and unspecified. Our aim is to evaluate a model of care developed to address these gaps. Integrated Behavioral Health-Prevention (IBH-P) is a collection of clinical strategies and structured approaches designed to promote emotional and behavioral health. IBH-P is delivered by psychologists in the pediatric setting as part of scheduled well-child visits. The overall objective of this study is to evaluate the efficacy of the intervention in promoting infant self-regulation. Maternal experience and satisfaction, adherence to well-child visits and immunizations will also be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Infant diagnosed as failure to thrive

• Infant exposure to illicit drugs in utero with the exception of THC

• Extensive care in the Neonatal Intensive Care Unit (>7 days)

• Child has other serious medical condition or acute psychosocial circumstances that results in child not receiving medical clearance from the pediatrician or psychologist for randomization

• mother or father of infant has received Building Futures intervention training

Related Conditions & MeSH terms

• Prevention

Intervention

Behavioral:
• Integrated Behavioral Health - Prevention
IBH-P consists of 15-30 minute visits with mothers as part of the 1, 2, 4, and 6 month well-child visits. The intervention is delivered by doctoral level pediatric psychologists that are an integrated member of the primary care team.
• Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition
Bright Futures curriculum will be delivered by the pediatrician as part of the 1, 2, 4 and 6 month well-child visits.

Locations

Country	Name	City	State
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (9)

Bright futures pocket guide (4th ed.). (2017). American Academy of Pediatrics.

Campo JV, Geist R, Kolko DJ. Integration of Pediatric Behavioral Health Services in Primary Care: Improving Access and Outcomes with Collaborative Care. Can J Psychiatry. 2018 Jul;63(7):432-438. doi: 10.1177/0706743717751668. Epub 2018 Apr 19. Review. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

MacPhee D. Knowledge of Infant Development Inventory: Manual. In. Colorado: Colorado State University; 2002.

Pachter LM, Lieberman L, Bloom SL, Fein JA. Developing a Community-Wide Initiative to Address Childhood Adversity and Toxic Stress: A Case Study of The Philadelphia ACE Task Force. Acad Pediatr. 2017 Sep - Oct;17(7S):S130-S135. doi: 10.1016/j.acap.2017.04.012. — View Citation

Putnam SP, Helbig AL, Gartstein MA, Rothbart MK, Leerkes E. Development and assessment of short and very short forms of the infant behavior questionnaire-revised. J Pers Assess. 2014;96(4):445-58. doi: 10.1080/00223891.2013.841171. Epub 2013 Nov 9. — View Citation

Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong ST, Haileamlak A, Gollogly L, Godlee F, Frizelle FA, Florenzano F, Drazen JM, Bauchner H, Baethge C, Backus J. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Ann Intern Med. 2017 Jul 4;167(1):63-65. doi: 10.7326/M17-1028. Epub 2017 Jun 6. — View Citation

Teti DM, Gelfand DM. Behavioral competence among mothers of infants in the first year: the mediational role of maternal self-efficacy. Child Dev. 1991 Oct;62(5):918-29. — View Citation

Winstanley A, Gattis M. The Baby Care Questionnaire: a measure of parenting principles and practices during infancy. Infant Behav Dev. 2013 Dec;36(4):762-75. doi: 10.1016/j.infbeh.2013.08.004. Epub 2013 Sep 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal experiences of violence and adversity in childhood	The Philadelphia Urban Adverse Childhood Experiences is a 22-item self-report that will be used to measure maternal experience of childhood violence and adversity. The total score is a tally of the 22 items endorsed with higher scores indicating more experiences of violence and adversity.	Baseline
Other	Adherence to well-child visits in first 7 months of life	The American Academy of Pediatrics recommends preventive pediatric care is provided across 5 visits in an infant's first 7 months of life. Percentage of adherence to the 5 well-child visits will be calculated.	Infants' birth through 7-months of age
Other	Health Service Utilization - Immunizations	Completion of immunizations at 5 months	Infants' birth through 5-months of age
Primary	Infant self-regulation	The Infant Behavior Questionnaire-Revised Very Short Form is a 36-item measure of three factors, positive affect, negative emotionality, and orienting/regulatory capacity. Scores range from 0 to 7, with higher scores representing greater positive affect, negative emotionality and orienting and regulatory capacity.	7-month follow-up
Primary	Parental knowledge of child development	The Knowledge of Infant Development Inventory is 58-item measure of caregiver knowledge of infant development. The total score will be calculated as the percentage of correct answers out of 58 items.	7-month follow-up
Primary	Maternal parenting behaviors	The Keys to Interactive Parenting Scale (KIPS) will be used to assess maternal parenting behaviors. KIPS is a structured observational measure and assesses 12 domains of parenting. The domains are scored on a 1 to 5-point scale with higher scores indicating higher quality parenting behaviors.	7-month follow-up
Secondary	Parenting beliefs and practices	The Baby Care Questionnaire is a 30-item measure of parenting belief and practices with 2 subscales, structure and attunement. Total scores range from 1 to 4 with higher scores indicating greater structure and attunement.	7-month follow-up
Secondary	Maternal feelings of efficacy in infant care	The Maternal Self-Efficacy Scale is a 10-item self-report of feelings of efficacy in infant care. The total score will be used and ranges from 10 to 40 with higher scores representing greater maternal self-efficacy.	7-month follow-up
Secondary	Maternal appraisement of life stress	The Perceived Stress Scale is a 14-item self-report of the degree to which situations in one's life within the past month are appraised as stressful. Scores range from 0 to 56 with higher scores indicating greater perceived stress.	7-month follow-up