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NCT Number: NCT06695663

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).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Christopher J Mehus

CONTACT

[email protected]

651-785-3660

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Referral and communication skills learning

Behavioral

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

Written guide to the referral process

Behavioral

assigned to receive only written information about the referral process

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.

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.

Primary outcomes

  1. Child behavior problems

    Time frame: 10 weeks

    Child externalizing and internalizing will be measured using the Behavioral Assessment System for Children - Behavioral and Emotional Screening System (BASC-3-BESS; 29 items).

  2. Change in parenting behavior

    Time frame: 10 weeks

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

  3. Number of Completed Referrals

    Time frame: 4 years

    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. Parent Attendance

    Time frame: 1 year

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

Secondary outcomes

  1. Parents mental health: depression

    Time frame: 10 weeks

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

  2. Parents mental health: anxiety

    Time frame: 10 weeks

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

  3. Parents mental health: absenteeism

    Time frame: 10 weeks

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

  4. Parenting self-efficacy

    Time frame: 10 weeks

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

  5. Intervention Acceptability, Appropriateness, and Feasibility Measure

    Time frame: 1 year

    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.

  6. Readiness to Change - Patient Preferences Subscale Score

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher J Mehus

CONTACT

[email protected]

651-785-3660

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Nov 19, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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