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Referral Training and eGen Trials

Referral Training and eGen Trials

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06695663
Enrollment
600
Registered
2024-11-19
Start date
2025-01-17
Completion date
2030-11-01
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral Problem, Behavioral Problem of Child

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).

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.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Child behavior problems10 weeksChild externalizing and internalizing will be measured using the Behavioral Assessment System for Children - Behavioral and Emotional Screening System (BASC-3-BESS; 29 items).
Change in parenting behavior10 weeksThe Alabama Parenting Questionnaire - Preschool version (APQ; 32 items) has subscales to measure positive parenting, inconsistent parenting, and punitive parenting.
Number of Completed Referrals4 yearsThis is defined as the number of parents who agree to begin treatment with the therapist after a referral from a primary care provider.
Parent Attendance1 yearParent attendance will be reported as the percent of sessions attended.

Secondary

MeasureTime frameDescription
Parents mental health: absenteeism10 weeksthe WHO Health and Work Performance Questionnaire - Short Form (HPQ SF, 8 items) will assess parent absenteeism.
Intervention Acceptability, Appropriateness, and Feasibility Measure1 yearAverage 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.
Parenting self-efficacy10 weeksParenting self-efficacy will be measured with the Parent Locus of Control measure (PLOC; 24 items).
Readiness to Change - Patient Preferences Subscale Score1 yearAverage 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.
Parents mental health: depression10 weeksThe patient health questionnaire will measure parent depression (PHQ-9; 9 items)
Parents mental health: anxiety10 weeksthe general anxiety disorder scale (GAD-7) will assess parent anxiety symptoms

Countries

United States

Contacts

Primary ContactChristopher J Mehus
cjmehus@umn.edu651-785-3660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026