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RecruitingNCT06695663Updated Dec 15, 2025

Referral Training and eGen Trials

An interventional study of Referral and communication skills learning and Written guide to the referral process in Behavioral Problem and Behavioral Problem of Child, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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).

02

Conditions studied

  • Behavioral Problem
  • Behavioral Problem of Child

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03

In context

Problem Behavior

178 studies on the registry are indexed under Problem Behavior; 47 are open to participants now.

This study's planned enrollment of 600 is above the median of 90 across 165 interventional studies indexed under Problem Behavior.

Browse Problem Behavior studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.

Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Primary care clinicians group 1

    PCCs with pediatric patients randomized to experimental group

    Behavioral: Referral and communication skills learning

  • Active comparator
    Primary care clinicians group 2

    PCCs with pediatric patients randomized to control group

    Behavioral: Written guide to the referral process

  • Experimental
    Parent group 1

    assigned to receive eGen

    Behavioral: Empowered Generations (eGen): parent training

  • Active comparator
    Parents group 2

    assigned to receive one-session control

    Behavioral: control

Interventions

  • BehavioralReferral and communication skills learning

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

  • BehavioralWritten guide to the referral process

    assigned to receive only written information about the referral process

  • BehavioralEmpowered 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.

  • Behavioralcontrol

    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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 10 weeks

  2. Change in parenting behavior

    The Alabama Parenting Questionnaire - Preschool version (APQ; 32 items) has subscales to measure positive parenting, inconsistent parenting, and punitive parenting.

    Time frame: 10 weeks

  3. 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.

    Time frame: 4 years

  4. Parent Attendance

    Parent attendance will be reported as the percent of sessions attended.

    Time frame: 1 year

Secondary outcomes

  1. Parents mental health: depression

    The patient health questionnaire will measure parent depression (PHQ-9; 9 items)

    Time frame: 10 weeks

  2. Parents mental health: anxiety

    the general anxiety disorder scale (GAD-7) will assess parent anxiety symptoms

    Time frame: 10 weeks

  3. Parents mental health: absenteeism

    the WHO Health and Work Performance Questionnaire - Short Form (HPQ SF, 8 items) will assess parent absenteeism.

    Time frame: 10 weeks

  4. Parenting self-efficacy

    Parenting self-efficacy will be measured with the Parent Locus of Control measure (PLOC; 24 items).

    Time frame: 10 weeks

  5. 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.

    Time frame: 1 year

  6. 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.

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06695663
Responsible party
Sponsor
First posted
Nov 19, 2024
Start date
Jan 17, 2025
Primary completion
Nov 1, 2028 (estimated)
Completion
Nov 1, 2030 (estimated)
Last update
Dec 15, 2025

Study contacts

Christopher J Mehus
Contact
cjmehus@umn.edu
651-785-3660
Christopher J Mehus
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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