Clinical trial NCT06695663: Referral Training and eGen Trials
Official title: Referral Training and eGen Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavioral Problem
Behavioral Problem of Child
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Child behavior problems
timeFrame: 10 weeks
measure: Change in parenting behavior
timeFrame: 10 weeks
measure: Number of Completed Referrals
timeFrame: 4 years
measure: Parent Attendance
timeFrame: 1 year
Secondary outcomes:
measure: Parents mental health: depression
timeFrame: 10 weeks
measure: Parents mental health: anxiety
timeFrame: 10 weeks
measure: Parents mental health: absenteeism
timeFrame: 10 weeks
measure: Parenting self-efficacy
timeFrame: 10 weeks
measure: Intervention Acceptability, Appropriateness, and Feasibility Measure
timeFrame: 1 year
measure: Readiness to Change - Patient Preferences Subscale Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Christopher J Mehus
role: PRINCIPAL_INVESTIGATOR
References: