Referral Training and eGen Trials

NCT06695663 | Recruiting

• 1 other identifier: cont
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Behavioral Problem of Child; Behavioral Problem

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Parents mental health: depression

  10 weeks

• Parents mental health: anxiety

  10 weeks

• Parents mental health: absenteeism

  10 weeks

• Parenting self-efficacy

  10 weeks

• Intervention Acceptability, Appropriateness, and Feasibility Measure

  1 year

Study Arms (4)

Primary care clinicians group 1

EXPERIMENTAL

PCCs with pediatric patients randomized to experimental group

Behavioral: Referral and communication skills learning

Primary care clinicians group 2

ACTIVE COMPARATOR

PCCs with pediatric patients randomized to control group

Behavioral: Written guide to the referral process

Parent group 1

EXPERIMENTAL

assigned to receive eGen

Behavioral: Empowered Generations (eGen): parent training

Parents group 2

ACTIVE COMPARATOR

assigned to receive one-session control

Behavioral: control

Interventions

control BEHAVIORAL

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.

Parents group 2

Written guide to the referral process BEHAVIORAL

assigned to receive only written information about the referral process

Primary care clinicians group 2

Empowered Generations (eGen): parent training BEHAVIORAL

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.

Parent group 1

Referral and communication skills learning BEHAVIORAL

assigned to receive a brief, live, experiential training on the referral process and communication strategies.

Primary care clinicians group 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Problem Behavior

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Christopher J Mehus

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher J Mehus

CONTACT

651-785-3660; cjmehus@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 19, 2024
• Study Start: January 17, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2030
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)