Referral Training and eGen Trials

NCT ID: NCT06695663

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2030-11-01

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; Behavioral Problem of Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Primary care clinicians group 1

PCCs with pediatric patients randomized to experimental group

Group Type: EXPERIMENTAL

Referral and communication skills learning

Intervention Type: BEHAVIORAL

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

Primary care clinicians group 2

PCCs with pediatric patients randomized to control group

Group Type: ACTIVE_COMPARATOR

Written guide to the referral process

Intervention Type: BEHAVIORAL

assigned to receive only written information about the referral process

Parent group 1

assigned to receive eGen

Group Type: EXPERIMENTAL

Empowered Generations (eGen): parent training

Intervention Type: 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.

Parents group 2

assigned to receive one-session control

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: 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.

Interventions

Referral and communication skills learning

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

Intervention Type: BEHAVIORAL

Written guide to the referral process

assigned to receive only written information about the referral process

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J Mehus

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher J Mehus

Role: CONTACT

cjmehus@umn.edu

651-785-3660

Facility Contacts

Christopher J Mehus

Role: primary

cjmehus@umn.edu

651-785-3660

Other Identifiers

cont

Identifier Type: -

Identifier Source: org_study_id