Referral Training and eGen Trials
- Conditions
- Behavioral ProblemBehavioral Problem of Child
- Registration Number
- NCT06695663
- Lead Sponsor
- University of Minnesota
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Child behavior problems 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 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 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 1 year Parent attendance will be reported as the percent of sessions attended.
- Secondary Outcome Measures
Name Time Method Parents mental health: depression 10 weeks The patient health questionnaire will measure parent depression (PHQ-9; 9 items)
Parents mental health: anxiety 10 weeks the general anxiety disorder scale (GAD-7) will assess parent anxiety symptoms
Parents mental health: absenteeism 10 weeks the WHO Health and Work Performance Questionnaire - Short Form (HPQ SF, 8 items) will assess parent absenteeism.
Parenting self-efficacy 10 weeks Parenting self-efficacy will be measured with the Parent Locus of Control measure (PLOC; 24 items).
Intervention Acceptability, Appropriateness, and Feasibility Measure 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.
Readiness to Change - Patient Preferences Subscale Score 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.
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States