Recruiting

Referral Training & eGen

Sponsor:

University of Minnesota

Code:

NCT06695663

Conditions

Behavioral Problem

Behavioral Problem of Child

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Referral and communication skills learning

Written guide to the referral process

Empowered Generations (eGen): parent training

control

Study Details

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 ID

NCT06695663

Start date

Jan 17, 2025

Status verified date

Dec, 2025

Completion date

Nov 1, 2030

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Primary care clinicians group 1

PCCs with pediatric patients randomized to experimental group

active comparator: Primary care clinicians group 2

PCCs with pediatric patients randomized to control group

experimental: Parent group 1

assigned to receive eGen

active comparator: Parents group 2

assigned to receive one-session control

Interventions

Referral and communication skills learning

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

Written guide to the referral process

assigned to receive only written information about the referral process

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.

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.

Primary outcome measure

  • Child behavior problems [ Time Frame: 10 weeks ]
  • Change in parenting behavior [ Time Frame: 10 weeks ]
  • Number of Completed Referrals [ Time Frame: 4 years ]
  • Parent Attendance [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Christopher J Mehus

651-785-3660cjmehus@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Christopher J Mehus

651-785-3660cjmehus@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-12-15.