Pediatric Behavioral Health Integrated Care: Indiana Statewide Strategic Plan to Address the Growing Mental Health Crisis

NCT07216638 | Enrolling By Invitation

• 2 other identifiers: 208910069660
• Study Type: observational
• Target: 575
• Locations: 1 country
• Sites: 1

Brief Summary

This research is designed to analyze the implementation and fidelity of Pediatric Integrated Behavioral Health (PEDS-IBH). PEDS-IBH is a multifaceted project designed to address the pediatric mental health crisis by providing prompt and continuing mental health resources to pediatric patients in the primary care setting. The belief is the best way to combat this crisis is through early detection and treatment. Primary care providers (PCP) play a vital role in helping youth with mental health disorders because most youth see their PCP on a yearly basis for their annual well-child visits. However, PCPs have many barriers to treating their young patients with mental health disorders: lack of training, resources, and support to deliver interventions, limited time with patients, and the only available referral options often come with long wait times for an appointment or are at a distance to far for the patient to travel. Indiana University Health (IU Health) has sought to address these concerns by implementing the PEDS-IBH program in 25 different pediatric primary care sites throughout the state of Indiana. Each location will focus on early detection through screening and will have an assigned social worker with either a bachelors or master's level degree. Social workers will administer FIRST or MATCH therapy respectively to those who have been referred and meet the qualifications within the patient's "home" IU Health Clinic. The goal of this project is to learn if clinics participating in PEDS-IBH will increase in early detection and delivery of effective youth mental health treatment. Ultimately leading to better health outcomes when compared to standard primary care detection and treatment. The research portion of PEDS-IBH has three aims, (Aim 1) Evaluate the implementation of the Peds IBH program including the uptake/adoption of and fidelity to the program. (Aim 2) Explore the facilitators and barriers to the implementation of the Peds IBH program. (Aim 3) Compare youth connection to behavioral health care pre- and post-implementation of the Peds IBH program, including time from referral to engagement in behavioral health services and use of emergency department, inpatient, and residential placements. The research team will interview and survey willing PCP's, clinic managers, and other clinic staff to gather information to address the aforementioned aims.

Conditions

Implementation Research; Depressive Disorder; ANXIETY DISORDERS (or Anxiety and Phobic Neuroses); Conduct Disorders in Children; Pediatric Mental Health Services

Keywords

Implementation; Pediatric Mental Health Services; Pediatric Mental Health; Depression; Anxiety; Conduct Disorders

Outcome Measures

Primary Outcomes (13)

• Physician Belief Scale

  Attitudinal constructs will be measured using a 14-item measure indexing providers attitudes toward management of psychosocial problems and comprises of two subscales (Belief and Feeling, Burden) (McLennan et al., 1999). Including one item to asses burnout. Utilizes a 5 point Likert Scale, with 1 being Strongly Disagree and 5 Being Strongly Agree.

  Surveys will be collected prior to implementation, then continue every six months for a total of 2 years.

• Organizational Constructs

  Implementation Climate Scale, an 18-item measure of the degree to which the organizational climate is supportive of evidence-based practice (EBP) adoption and consists of six subscales (focus on EBP, educational support for EBP, recognition for EBP, rewards for EBP, selection for EBP, and selection for openness). Utilizes a 5 point Likert-type Scale, with 0 being "Not at All" and 4 being "Very great extent". Implementation Leadership Scale (Aarons et al., 2014), a 6-item measure of leadership support for EBP, specifically Peds IBH, implementation and Primary Care Dynamics Survey. Which is also a 5 point Likert-type Scale, with 0 being "Not at All" and 4 being "Very great extent". And an 11-item measure of primary care team dynamics (Song et al., 2015), from which we included two subscales (process for communication and information exchange, and acting and feeling like a team). Which uses a Utilizes a 5 point Likert Scale, with 1 being "Strongly Disagree" and 5 being "Strongly Agree".

  Surveys will be collected prior to implementation, then continue every six months for a total of 2 years.

• Implementation Outcomes

  Behavioral Health Screening, Referral, and Consultation Experience and Implementation, developed to assess provider-reported behavior and includes seven items at pre-implementation and 10 at mid- and post-implementation. All questions using a visual analogue scale, with 0 being the lowest and 100 being the highest.

  Surveys will be collected prior to implementation, then continue every six months for a total of 2 year.

• Acceptability, Feasibility, and Appropriateness Measure

  Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention Measure, a 12-item measure of the acceptability, feasibility, and appropriateness of the implemented program, Peds IBH. Which uses a Utilizes a 5 point Likert Scale, with 1 being "Completely Disagree" and 5 being "Completely Agree".

  Surveys will be collected prior to implementation, then continue every six months for a total of 2 year.

• System Usability Scale

  Systems Usability Scale, a 12-item measure of the usability and learnability of a given system, which was adapted to assess the Kiddie-Computerized Adaptive Tests (K-CAT) screening tool. Utilizes a 5 point Likert Scale, with 1 being Strongly Disagree and 5 Being Strongly Agree.

  Surveys will be collected prior to implementation, then continue every six months for a total of 2 year.

• Provider Report of Sustainment Scale

  Provider Report of Sustainment Scale, a 3-item measure of the sustainability or continued use of the implemented program, Peds IBH. Utilizes 5 point Likert Scale, with the lowest point being "Not at all" and the highest point being "To a Very Great Extent".

  Surveys will be collected prior to implementation, then continue every six months for a total of 2 years.

• Confidence in Ability to Identify Behavioral Health Concerns and Connect to Services

  Barriers encountered when implementing the Peds IBH program, and suggested improvement/resources/trainings using seven items. Utilizing an 11 point Likert Scale, with O being the lowest and 10 being the highest. As well as 3 open-ended text box questions.

  Surveys will be collected prior to implementation, then continue every six months for a total of 2 years.

• Screening Rates

  Percent of youth screened for Mental Health Disorders. Measuring screening rates as the percent of 7- to 17-year-olds who have PSC-17 and/or PHQ-2/-9 screening results.

  From clinical trial launch, data will be collected twice a year, for a total of four years

• Referral Rates

  Percent of youth referred to FIRST therapy for treatment. Referral rates to the Peds IBH program as the percent of patients with a positive screen who are referred to the Peds IBH program.

  From clinical trial launch, data will be collected twice a year, for a total of four years.

• PEDS-IBH Implementation Opinion via Clinic Interviews

  Semi-structured interviews involving a Nurse/MA, PCP, and clinic manager of participating PEDS-IBH clinics. Interviews will be conducted virtually by a member of the implementation team. Interviews will inquire about the process for determining if a youth is in need of behavioral health services and shifts in this process following Peds IBH program implementation; their clinic's behavioral health screening and referral process; and Peds IBH program feasibility, fit, integration, implementation, and barriers and facilitators to implementation.

  Interviews will be collected prior to implementation, then continue every six months for a total of 1 year

• Provider 2 Provider (P2P) Consultation Calls

  Number of P2P Consultation Calls. Data will be provided from the BeHappy and AAA consultation lines on number of consultation calls from participating clinics.

  From clinical trial launch, data will be collected twice a year, for a total of four years.

• Top Problem Assessment

  Youth and their caregiver(s) who participate in the FIRST intervention will complete the Kiddie-Computerized Adaptive Tests (K-CAT) at pre- and post-treatment and Top Problems Assessment at each session to evaluate treatment outcomes. The K-CAT and Top Problems Assessment will be administered as part of routine care for youth receiving the FIRST intervention. The Top Problems Assessment is an idiographic assessment of youth and caregiver identified top problems.

  From clinical trial launch, data will be collected twice a year, for a total of four years.

• Assess Youth Engagement in Services

  Measure rates of youth engagement in the Peds IBH program. This data will be collected through administrative data in the EHR. We will measure 1) the percent of youth referred to the Peds IBH program who schedule a Peds IBH assessment appointment, 2) the percent of youth who have a scheduled assessment appointment who attend the appointment, 3) the percent of youth indicated as appropriate for Peds IBH services who attend at least one session of FIRST, and 4) the number of total FIRST sessions attended.

  From clinical trial launch, data will be collected twice a year, for a total of four years.

Study Arms (2)

Primary Care Practice As Usual

Data are collected regarding standard primary care practice and outcomes before the implementation of PEDS-IBH

Integrated Behavioral Health with PEDS-IBH Resources

Participating clinics receive a system-level intervention, PEDS-IBH. Designed to improve youth mental health detection and treatment.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IU Health and Riley Primary Care Clinics

You may qualify if:

• member of participating pediatric primary care team in participating PEDS-IBH clinics
• at least 18 years old
• speaks and understanding English.
• patient at one of the participating pediatric primary care team
• years old -

You may not qualify if:

• N/A

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Phobic Disorders; Depression; Conduct Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Leslie A Hulvershorn, MD

  Indiana University/Indiana University Health

  PRINCIPAL INVESTIGATOR

• Matthew C Aalsma, PhD

  Indiana University/Indiana University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Johnathan & Jennifer Simmons Professor of Pediatrics & Director of the Child Health Services Research Division and the Adolescent Behavioral Health Research Program

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 14, 2025
• Study Start: November 28, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)