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Recruiting NCT06695663

Referral Training and eGen Trials

No phase Interventional Behavioral Problem Behavioral Problem of Child

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Referral and communication skills learning, Written guide to the referral process, Empowered Generations (eGen): parent training, control.
Who it may be relevant to
Registry conditions: Behavioral Problem, Behavioral Problem of Child. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Behavioral Referral and communication skills learning
    assigned to receive a brief, live, experiential training on the referral process and communication strategies.
  • Behavioral Written guide to the referral process
    assigned to receive only written information about the referral process
  • Behavioral Empowered 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.
  • Behavioral control
    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.

Primary outcome measures

  • Child behavior problems [Time frame: 10 weeks]
  • Change in parenting behavior [Time frame: 10 weeks]
  • Number of Completed Referrals [Time frame: 4 years]
  • Parent Attendance [Time frame: 1 year]
Secondary outcome measures (6)
  • Parents mental health: depression [Time frame: 10 weeks]
  • Parents mental health: anxiety [Time frame: 10 weeks]
  • Parents mental health: absenteeism [Time frame: 10 weeks]
  • Parenting self-efficacy [Time frame: 10 weeks]
  • Intervention Acceptability, Appropriateness, and Feasibility Measure [Time frame: 1 year]
  • Readiness to Change - Patient Preferences Subscale Score [Time frame: 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT06695663 · cont

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗