Referral Training and eGen Trials

Child and adolescent behavioral health problems are related to the leading causes of youth morbidity and mortality. Parent-focused interventions effectively prevent behavioral health problems such as depression and conduct disorders and can provide a downstream economic benefit to society by reducing criminal activity, education costs, and health care use.

Unfortunately, parenting programs are not widely available, accessible, nor well-attended.

Pediatric primary care is a non-stigmatizing setting with nearly universal reach and, therefore, an ideal contact point to increase access. However, primary care clinicians (PCCs) often have insufficient training in behavioral health topics and typical referral practices are inadequate.

There are also logistical barriers to attending in-person parenting programs, like the need for childcare and a large time-commitment. There is a need to develop effective referral practices in conjunction with increasing the accessibility of parenting programs. The study long-term goal is to prevent significant behavioral health problems through widespread access to effective and accessible parenting programs through primary care referrals.

In this study there are two trials: First is the primary care clinicians "PCC" trial, testing the effectiveness of referral training (aim 1). Second is the parents "eGen" trial provided by therapists, testing the effectiveness of eGen parenting intervention (aim 2).

Study Overview

• Status: Recruiting
• Conditions: Behavioral Problem; Behavioral Problem of Child
• Intervention / Treatment: Behavioral: Referral and communication skills learning; Behavioral: Written guide to the referral process; Behavioral: Empowered Generations (eGen): parent training; Behavioral: control

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher J Mehus; Phone Number: 651-785-3660; Email: cjmehus@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Christopher J Mehus; Phone Number: 651-785-3660; Email: cjmehus@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Inclusion criteria for parent in the randomized controlled trial include being a parent or caregiver of a child ages 3 to 8 and having a referral to a participating therapist from a primary care provider.
• The only inclusion criteria is that participants be a PCC who sees children between the ages of 3- 8 years old. PCCs must also have approval from their clinic to participate. Vulnerable populations will not be targeted from inclusion but may be included if they meet the previously stated inclusion criteria.

Exclusion Criteria:

• Parents would be excluded if there is a reasonable belief that participating could increase danger to a child or if they are psychologically unable to engage in the intervention activities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary care clinicians group 1; PCCs with pediatric patients randomized to experimental group	Behavioral: Referral and communication skills learning; assigned to receive a brief, live, experiential training on the referral process and communication strategies.
Active Comparator: Primary care clinicians group 2; PCCs with pediatric patients randomized to control group	Behavioral: Written guide to the referral process; assigned to receive only written information about the referral process
Experimental: Parent group 1; assigned to receive eGen	Behavioral: Empowered Generations (eGen): parent training; eGen is a six-session parent training program provided by therapists via video chat online to parents with a child between the ages of 3-8 years.
Active Comparator: Parents group 2; assigned to receive one-session control	Behavioral: control; The control condition consists of a single scripted session, in which therapists guide the parent to the following resources: (a) a book, Raising Cooperative Kids, by GenPMTO co-developer Marion Forgatch; (b) vetted parenting advice websites; (c) information about Early Childhood and Family Education classes, which are provided for free in Minnesota through public schools; and (d) a list of culturally tailored parenting advice websites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child behavior problems	Child externalizing and internalizing will be measured using the Behavioral Assessment System for Children - Behavioral and Emotional Screening System (BASC-3-BESS; 29 items).	10 weeks
Change in parenting behavior	The Alabama Parenting Questionnaire - Preschool version (APQ; 32 items) has subscales to measure positive parenting, inconsistent parenting, and punitive parenting.	10 weeks
Number of Completed Referrals	This is defined as the number of parents who agree to begin treatment with the therapist after a referral from a primary care provider.	4 years
Parent Attendance	Parent attendance will be reported as the percent of sessions attended.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parents mental health: depression	The patient health questionnaire will measure parent depression (PHQ-9; 9 items)	10 weeks
Parents mental health: anxiety	the general anxiety disorder scale (GAD-7) will assess parent anxiety symptoms	10 weeks
Parents mental health: absenteeism	the WHO Health and Work Performance Questionnaire - Short Form (HPQ SF, 8 items) will assess parent absenteeism.	10 weeks
Parenting self-efficacy	Parenting self-efficacy will be measured with the Parent Locus of Control measure (PLOC; 24 items).	10 weeks
Intervention Acceptability, Appropriateness, and Feasibility Measure	Average score on the Acceptability of intervention Measure items. These measures are on a 1-5 scale from completely disagree to completely agree. A higher score indicates higher acceptability, appropriateness, or feasibility.	1 year
Readiness to Change - Patient Preferences Subscale Score	Average score on the Readiness to Change Assessment, patient preferences items (Helfrich, Li; Sharp, 2009). This measure is rated on a 1-5 scale from strongly disagree to strongly agree, with a sixth option for not applicable. High scores indicates greater acceptability.	1 year

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Christopher J Mehus, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Child Behavior; Problem Behavior; Professional Practice; Organization and Administration; Health Services Administration; Referral and Consultation
• Other Study ID Numbers: cont

Drug and device information, study documents

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