Health TrialsbyHealthPanel

Referral Training and eGen Trials

ConditionsBehavioral ProblemBehavioral Problem of Child
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Minnesota

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Referral and communication skills learning

    Behavioral

    assigned to receive a brief, live, experiential training on the referral process and communication strategies.

  • Written guide to the referral process

    Behavioral

    assigned to receive only written information about the referral process

  • Empowered Generations (eGen): parent training

    Behavioral

    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.

  • control

    Behavioral

    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.

Treatment groups

600 Participants
are divided into 4 treatment groups
Group A: Primary care clinicians group 1Experimental treatment 1 intervention
Group B: Primary care clinicians group 2Active comparator 1 intervention
Group C: Parent group 1Experimental treatment 1 intervention
Group D: Parents group 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Child behavior problems

Child externalizing and internalizing will be measured using the Behavioral Assessment System for Children - Behavioral and Emotional Screening System (BASC-3-BESS; 29 items).

Time frame
10 weeks
2

Change in parenting behavior

The Alabama Parenting Questionnaire - Preschool version (APQ; 32 items) has subscales to measure positive parenting, inconsistent parenting, and punitive parenting.

Time frame
10 weeks
3

Number of Completed Referrals

This is defined as the number of parents who agree to begin treatment with the therapist after a referral from a primary care provider.

Time frame
4 years
4

Parent Attendance

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

Time frame
1 year

Secondary outcomes

1

Parents mental health: depression

The patient health questionnaire will measure parent depression (PHQ-9; 9 items)

Time frame
10 weeks
2

Parents mental health: anxiety

the general anxiety disorder scale (GAD-7) will assess parent anxiety symptoms

Time frame
10 weeks
3

Parents mental health: absenteeism

the WHO Health and Work Performance Questionnaire - Short Form (HPQ SF, 8 items) will assess parent absenteeism.

Time frame
10 weeks
4

Parenting self-efficacy

Parenting self-efficacy will be measured with the Parent Locus of Control measure (PLOC; 24 items).

Time frame
10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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