Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants

NCT04825210 | Completed

• 1 other identifier: 2020-1007
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prevention

Keywords

Behavioral Health; Integrated Behavioral Health; Infant Self-Regulation; Parenting Skills

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Parenting beliefs and practices

  7-month follow-up

• Maternal feelings of efficacy in infant care

  7-month follow-up

• Maternal appraisement of life stress

  7-month follow-up

Other Outcomes (3)

• Maternal experiences of violence and adversity in childhood

  Baseline

• Adherence to well-child visits in first 7 months of life

  Infants' birth through 7-months of age

• Health Service Utilization - Immunizations

  Infants' birth through 5-months of age

Study Arms (2)

Integrated Behavioral Health - Prevention (IBH-P)

EXPERIMENTAL

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

Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition

ACTIVE COMPARATOR

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

Interventions

Integrated Behavioral Health - Prevention BEHAVIORAL

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.

Integrated Behavioral Health - Prevention (IBH-P)

Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition BEHAVIORAL

Bright Futures curriculum will be delivered by the pediatrician as part of the 1, 2, 4 and 6 month well-child visits.

Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (9)

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

  BACKGROUND

• 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.

  PMID: 24206185 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24050932 BACKGROUND

• 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.

  PMID: 1756667 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 28865645 BACKGROUND

• 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.

  PMID: 29673268 BACKGROUND

• 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.

  PMID: 28586790 BACKGROUND

Study Officials

• Robert T Ammerman, PhD

  Cincinnati Children's Hospital Medical Center Cincinnati, OH USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: April 13, 2021
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data and supporting information will be made available three months after publication of the primary article and ending five years after publication.
• 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).

Locations

US (1)