Referral Training and eGen Trials

University of Minnesota (UMN)

Status: Enrolling

Conditions: Behavioral Problem of Child; Behavioral Problem

Treatments: Behavioral: control; Behavioral: Referral and communication skills learning; Behavioral: Written guide to the referral process; Behavioral: Empowered Generations (eGen): parent training

Study type: Interventional

Funder types: Other

Identifiers

NCT06695663

cont

Details and patient eligibility

About

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).

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

Primary care clinicians group 1

Experimental group

Description:

PCCs with pediatric patients randomized to experimental group

Treatment:

Behavioral: Referral and communication skills learning

Primary care clinicians group 2

Active Comparator group

Description:

PCCs with pediatric patients randomized to control group

Treatment:

Behavioral: Written guide to the referral process

Parent group 1

Experimental group

Description:

assigned to receive eGen

Treatment:

Behavioral: Empowered Generations (eGen): parent training

Parents group 2

Active Comparator group

Description:

assigned to receive one-session control

Treatment:

Behavioral: control