Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants

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.

Study Overview

• Status: Completed
• Conditions: Prevention
• Intervention / Treatment: Behavioral: Integrated Behavioral Health - Prevention; Behavioral: Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Integrated Behavioral Health - Prevention (IBH-P); 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.	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.
ACTIVE_COMPARATOR: Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Health Service Utilization - Immunizations	Completion of immunizations at 5 months	Infants' birth through 5-months of age

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Robert T Ammerman, PhD, Cincinnati Children's Hospital Medical Center Cincinnati, OH USA

Publications and helpful links

General Publications

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
• 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.
• Bright futures pocket guide (4th ed.). (2017). American Academy of Pediatrics.
• MacPhee D. Knowledge of Infant Development Inventory: Manual. In. Colorado: Colorado State University; 2002.
• 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.
• 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. doi: 10.1111/j.1467-8624.1991.tb01580.x.
• 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.
• 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.
• 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. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 13, 2021
• Primary Completion (ACTUAL): August 24, 2022
• Study Completion (ACTUAL): August 24, 2022

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Behavioral Health; Integrated Behavioral Health; Parenting Skills; Infant Self-Regulation
• Other Study ID Numbers: 2020-1007 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Consistent with the open science movement and with the directive of clinicaltrials.gov to include a data sharing plan in submissions, we will have the following data sharing policy: we will share with other investigators (1) all individual participant data after deidentification, and (2) study management documents (protocol, statistical analysis plan, consent form, analytic code, data dictionary).
• IPD Sharing Time Frame: Data and supporting information will be made available three months after publication of the primary article and ending five years after publication.
• IPD Sharing Access Criteria: Those requesting data will be required to submit a proposal to Robert.Ammerman@cchmc.org. This will be reviewed by the investigative team for methodological soundness and scientific merit before data is shared. This plan is consistent with guidelines developed by the International Committee of Medical Journal Editors (Taichman et al., 2017).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No