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Clinical Trials/NCT06695663
NCT06695663
Recruiting
N/A

Referral Training and eGen Trials

University of Minnesota1 site in 1 country600 target enrollmentJanuary 17, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Behavioral Problem
Sponsor
University of Minnesota
Enrollment
600
Locations
1
Primary Endpoint
Child behavior problems
Status
Recruiting
Last Updated
4 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 17, 2025
End Date
November 1, 2030
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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).

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.

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.

Parent Attendance

Time Frame: 1 year

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

Secondary Outcomes

  • Parents mental health: depression(10 weeks)
  • Parents mental health: anxiety(10 weeks)
  • Parents mental health: absenteeism(10 weeks)
  • Parenting self-efficacy(10 weeks)
  • Intervention Acceptability, Appropriateness, and Feasibility Measure(1 year)
  • Readiness to Change - Patient Preferences Subscale Score(1 year)

Study Sites (1)

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