Behavioral ProblemNCT06695663
Referral Training and eGen Trials
A study testing Referral and communication skills learning, Written guide to the referral process and Empowered Generations (eGen): parent training in people with Behavioral Problem and Behavioral Problem of Child, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Problem, Behavioral Problem of Child
- What is being tested?
- Referral and communication skills learning, Written guide to the referral process and Empowered Generations (eGen): parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to 1 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Christopher J Mehus, 651-785-3660, cjmehus@umn.edu
About this study
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.
Read more
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).
- Conditions
- Behavioral Problem, Behavioral Problem of Child
- Being tested
- Referral and communication skills learning, Written guide to the referral process, Empowered Generations (eGen): parent training, control
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral and communication skills learningBehavioural
assigned to receive a brief, live, experiential training on the referral process and communication strategies.
Written guide to the referral processBehavioural
assigned to receive only written information about the referral process
Empowered Generations (eGen): parent trainingBehavioural
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.
controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary care clinicians group 1 | Experimental | PCCs with pediatric patients randomized to experimental group Receives: Behavioral: Referral and communication skills learning |
| Primary care clinicians group 2 | Active comparator | PCCs with pediatric patients randomized to control group Receives: Behavioral: Written guide to the referral process |
| Parent group 1 | Experimental | assigned to receive eGen Receives: Behavioral: Empowered Generations (eGen): parent training |
| Parents group 2 | Active comparator | assigned to receive one-session control Receives: Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 weeks
Change in parenting behavior
The Alabama Parenting Questionnaire - Preschool version (APQ; 32 items) has subscales to measure positive parenting, inconsistent parenting, and punitive parenting.
Measured: 10 weeks
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.
Measured: 4 years
Parent Attendance
Parent attendance will be reported as the percent of sessions attended.
Measured: 1 year
Secondary outcomes (6)
Parents mental health: depression
The patient health questionnaire will measure parent depression (PHQ-9; 9 items)
Measured: 10 weeks
Parents mental health: anxiety
the general anxiety disorder scale (GAD-7) will assess parent anxiety symptoms
Measured: 10 weeks
Parents mental health: absenteeism
the WHO Health and Work Performance Questionnaire - Short Form (HPQ SF, 8 items) will assess parent absenteeism.
Measured: 10 weeks
Parenting self-efficacy
Parenting self-efficacy will be measured with the Parent Locus of Control measure (PLOC; 24 items).
Measured: 10 weeks
Intervention Acceptability, Appropriateness, and Feasibility Measure
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.
Measured: 1 year
Readiness to Change - Patient Preferences Subscale Score
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start17 Jan 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher J Mehus, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695663
- Sponsor's protocol ID
- cont
- Status last verified
- Dec 2025
- First submitted
- 31 Oct 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Referral Training and eGen Trials
- ClinicalTrials.gov ID
- NCT06695663
- Acronym / sponsor ID
- cont
- Conditions
- Behavioral Problem, Behavioral Problem of Child
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary care clinicians group 1 | Experimental | Behavioral: Referral and communication skills learningPCCs with pediatric patients randomized to experimental group |
| Primary care clinicians group 2 | Active comparator | Behavioral: Written guide to the referral processPCCs with pediatric patients randomized to control group |
| Parent group 1 | Experimental | Behavioral: Empowered Generations (eGen): parent trainingassigned to receive eGen |
| Parents group 2 | Active comparator | Behavioral: controlassigned to receive one-session control |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral and communication skills learningassigned to receive a brief, live, experiential training on the referral process and communication strategies. | Behavioural | Primary care clinicians group 1 |
| Written guide to the referral processassigned to receive only written information about the referral process | Behavioural | Primary care clinicians group 2 |
| Empowered Generations (eGen): parent trainingeGen 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. | Behavioural | Parent group 1 |
| controlThe 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. | Behavioural | Parents group 2 |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher J Mehus principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral and communication skills learning, Written guide to the referral process and Empowered Generations (eGen): parent training in people with Behavioral Problem and Behavioral Problem of Child, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher J Mehus (651-785-3660, cjmehus@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child behavior problems (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.