Behavior ProblemNCT05111886
Effectiveness of an Online Parenting Training
A study testing Communication Skills Training, eHealth GenPMTO and Written Referral Process in people with Behavior Problem and Behavior, 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 preventive interventions, such as GenerationPMTO (GenPMTO), effectively prevent behavioral health problems such as depression and conduct disorders. Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problem, Behavior, Child, Parents
- What is being tested?
- Communication Skills Training, eHealth GenPMTO and Written Referral Process
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants are eligible for Aim 1 if they are:
- Able to speak English
- Able to participate in the focus group
- Participants are eligible for Aim 2 if they are:
- Primary care personnel who are currently practicing in a collaborating clinic
- Therapists who are eligible for reimbursement from insurance and Medicaid
Show all 10Show fewer
- Parents who are:
- Referred to a therapist by their providers
- Have the ability to speak English or Spanish, and
- Are a primary caregiver for a child between the ages of 3 and 5 years old
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Child and adolescent behavioral health problems are related to the leading causes of youth morbidity and mortality. Parent-focused preventive interventions, such as GenerationPMTO (GenPMTO), effectively prevent behavioral health problems such as depression and conduct disorders. Unfortunately, parenting programs are not widely available nor well-attended. Pediatric primary care (PC) is a non-stigmatizing setting with nearly universal reach and, therefore, an ideal access point to increase availability. However, PC personnel are not trained to address behavioral health topics. Also, typical referral practices are inadequate. There is a need to develop effective referral practices in conjunction with increasing availability. 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 overcome these logistical barriers with more accessible programs. The long-term goal is to prevent significant behavioral health problems by increasing access to GenPMTO.
Read the detailed description
Specifically, the investigators propose engaging parents of 3 to 5-year-olds with moderate externalizing or internalizing symptoms through pediatric primary care (PC); PC personnel will refer parents to a community therapist who will deliver a novel brief eHealth (i.e. online video-chat) model of GenPMTO. Collaborating clinics are part of a Federally Qualified Health Center (FQHC), allowing for access to an under-served population of parents.
The primary objective of this project is to test a brief eHealth version of GenPMTO, delivered to parents online by community therapists (Aim 3). Brief online delivery can overcome logistical barriers, thereby increasing access while maintaining effectiveness. An additional objective is to develop (Aim 1) and test (Aim 2) a brief training for PC personnel and a referral process to equip them to effectively refer parents to eHealth GenPMTO, thereby increasing access to needed services through effective engagement in a trusted setting.
To achieve these objectives, the following aims will be completed. Aim 1 is a development phase to inform Aim 2 components. Aims 2 and 3 run concurrently in the study; the order of the aims reflects the patient flow.
Aim 1: Develop a referral process and a training for PC personnel by gathering mixed-method expert and stakeholder input and feedback. The investigators will present a proposed referral process and PC personnel training, and solicit feedback via the Nominal Group Technique from four expert groups: (1) researchers and implementers (n=6) with experience delivering other parenting interventions though primary care in the U.S., (2) primary care personnel (n=9) from FQHC primary care clinics, (3) personnel from British Columbia (n=6) who have implemented brief GenPMTO over the telephone with parents referred by primary care, and (4) parents (n=6) who receive care from an FQHC. One key question that will be addressed is which PC personnel (e.g., provider, nurse) is best suited to have the referring conversation with parents and receive the training.
Aim 2: Evaluate the referral process and conduct a pilot test of the PC personnel training within FQHC clinics. PC personnel (n=35) within two FQHC primary care clinics will be randomly assigned to receive communication skills training or a control condition. Control group personnel will receive a written description of the referral process but no training. Aim 2a: Using a sequential mixed-methods approach with PC personnel, the investigators will evaluate the acceptability and appropriateness of the referral process and the training. The investigators will also interview parents who do not complete a referral (n=10) to examine the acceptability of the referral process and identify remaining barriers to engagement. Aim 2b: The investigators will pilot test the effectiveness of the training to increase PC personnel's communication skills. The investigators will also use EHR data to pilot test the effect of the training on parent engagement in GenPMTO by comparing the rates of referral and engagement among patients who had an appointment with personnel in the training arm to those seeing control personnel.
Aim 3: Pilot test a brief, eHealth version of GenerationPMTO for moderate externalizing or internalizing symptoms. The personnel described in Aim 2 will refer parents to GenPMTO. Aim 3a: With the referred parents, the investigators will conduct a pilot RCT to examine change in parents' (n=60) parenting locus of control, self-reported parenting behaviors, and child externalizing and internalizing, all of which have been shown to predict later changes in child behavioral health outcomes. The investigators will examine the mediating effect of parenting changes on changes in child outcomes. These effect sizes will also be compared to effect sizes from other GenPMTO studies to determine if this preliminary assessment aligns with findings from other versions of GenPMTO. Aim 3b: Using a sequential mixed-methods approach, the investigators will assess the acceptability, feasibility, and appropriateness of brief, eHealth GenPMTO among therapists (n=15) and a sub-sample of parents (n=14).
- Conditions
- Behavior Problem, Behavior, Child, Parents, Parent-Child Relations
- Being tested
- Communication Skills Training, eHealth GenPMTO, Written Referral Process, One Session Education about Resources, Survey of Experience
- Keywords
- Parent program, GenerationPMTO, Primary care referral, pediatric referral, Primary care communication skills training, Online delivery, Brief interventions, Parents of 3-5 year old children, Behavior concerns, Parent behavior, Child externalizing, child internalizing, Acceptability, appropriateness, feasibility
- Medical subject headings
- Mental Disorders, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Skills TrainingBehavioural
The training will focus on communication skills based on key constructs in the Health Belief Model and motivation/resistance research (described in section A3), the training will focus on: (1) conveying the benefits of parenting programs, (2) knowledge of and responses to common perceived barriers to attending parenting programs, and (3) skills and strategies to effectively motivate and refer parents in ways that are least likely to elicit resistance. The in-person training will last 60-90 minutes. It will include a theoretical background and experiential learning; each step of the referral process will be demonstrated and role-played. The investigators will work to ensure that personnel receive continuing education credits for the training.
eHealth GenPMTOBehavioural
The GenPMTO is delivered over the phone (not online). This version is up to 6 sessions in length. This brief eHealth version of GenPMTO will be delivered through community therapists. The program will be delivered one-on-one (i.e., between a therapist and a parent or couple).
Written Referral ProcessBehavioural
A written summary and process map of the referral process, modeled on the Institute for Healthcare Improvement (IHI) 9-step process for "closing the loop" on referrals.
One Session Education about ResourcesBehavioural
One online or phone conversation with the therapist in which the therapist guides the parent to the following resources: (a) a book, Raising Cooperative Kids, by GenPMTO co-developer Marion Forgatch; (b) a website, behaviorchecker.org, which includes behavioral "prescriptions" for common behavior issues; and (c) information about Early Childhood and Family Education classes, which are provided for free in Minnesota through public schools.
Survey of ExperienceDiagnostic test
Satisfaction with referral process
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Personnel Training | Experimental | Primary care personnel within two Federally Qualified Health Center (FQHC) primary care clinics will be randomly assigned to receive communication skills training or a control condition. Receives: Behavioral: Communication Skills Training; Diagnostic Test: Survey of Experience |
| Primary Care Personnel Training Control | Active comparator | Primary care personnel within two Federally Qualified Health Center (FQHC) primary care clinics will be randomly assigned to receive communication skills training or a control condition. Control group personnel will receive a written description of the referral process but no training. Receives: Behavioral: Written Referral Process; Diagnostic Test: Survey of Experience |
| Parents eHealth GenPMTO | Experimental | Parents of 3- to 5-year-olds who receive services from primary care personnel at an Federally Qualified Health Center (FQHC) primary care clinic. Primary care personnel will refer parents of child with externalizing or internalizing behaviors to study therapists. Parents may be assigned to GenPMTO or control after referral. Receives: Behavioral: eHealth GenPMTO; Diagnostic Test: Survey of Experience |
| Parents Control | Active comparator | Parents of 3- to 5-year-olds who receive services from primary care personnel at an Federally Qualified Health Center (FQHC) primary care clinic. Primary care personnel will refer parents of child with externalizing or internalizing behaviors to study therapists. Parents may be assigned to GenPMTO or control after referral. Receives: Behavioral: One Session Education about Resources; Diagnostic Test: Survey of Experience |
| Therapists | Other | Community therapists trained to deliver GenPMTO. Receives: Diagnostic Test: Survey of Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 3: Change in Behavioral Assessment System Child Score
Outcome is reported as the difference in pre- and post-intervention Externalizing Risk Scores, a subscale from the Behavior Assessment System for Children (3rd Edition, Parent Report Form - Preschool), which measures externalizing, internalizing, and adaptive behaviors. The Externalizing Risk Scores subscale measures externalizing behaviors the sum of using 9 items with a four-choice response format, for a raw Externalizing Risk Score range of 0-27. Higher scores indicate worse levels of externalizing behavior functioning. Scores of 0-10 are in the normal risk range, scores of 11-19 are elevated, and scores of 20 or above are extremely elevated. This is administered to parents before and after the intervention window (8 week separation). The change score was calculated as the value at 8 weeks minus value at baseline.
Measured: 8 weeks
Aim 3: Change in Alabama Parenting Questionnaire
Outcome is reported as the difference in total scale score on the Alabama Parenting Questionnaire (preschool version) (Clerkin et al., 2007). This questionnaire contains 32 items rated on a 5-point scale ranging from "Never" to "Always." Total scores range from 32 to 160 with higher score indicating more involvement and positive parenting. This is administered to parents before and after the intervention window (8 week separation).
Measured: 8 weeks
Aim 3: Change in Parent Locus of Control
Outcome is reported as the difference in total scores on the Parent Locus of Control measure (Lovejoy et al., 1997). This measure contains 24 items rated on a 5-point scale from strongly disagree (1) to strongly agree (5). Scores range from 24 to 120. High scores on the scale indicate an external locus of parenting control and low scores indicate an internal locus. This is administered to parents before and after the intervention window (8 week separation).
Measured: 8 weeks
Aim 2: Percentage of Completed Referrals
Percentage of eligible appointments leading to successful referral.
Measured: 1 year
Aim 2: Parent Attendance
For each referred caregiver, the number of sessions attended (0-6) was divided by the total possible number of sessions (6), to calculate the percent of sessions attended. The average was then calculated by referring clinician condition (training or control).
Measured: 1 year
Aim 1: Fidelity of Implementation Rating System
Communication skills rating will be measured using the Support and Guide Observational Coding Scale of audio-recorded provider responses to clinical vignettes, a measure adapted from the Fidelity of Implementation Rating System. The scale measures the communication skills of supporting, guiding, confronting (reverse-coded), teaching (reverse-coded), and tone. Each of these components is averaged across the three vignettes on a 0-3 scale (support, guide, confront, teach), or a 0-2 scale (tone). A total scale is then summed for a total scale score range of 0-14, with higher scores indicating greater communication skills. These vignette prompts are administered to providers before and after the pilot year (1 year separation).
Measured: 1 year
Secondary outcomes (4)
Intervention Acceptability Measure
Average score on the Acceptability of intervention Measure (4 items) (Weiner et al., 2017), which assesses acceptability, or belief that the training is agreeable or satisfactory. Scores are on a 1-5 scale from completely disagree to completely agree, and all four items are averaged for a total score range of 1 to 5. A higher score indicates higher acceptability. This is administered to parents after the intervention window (8 week separation) and to providers and therapists before and after the pilot year (1 year separation).
Measured: 8 weeks (Parents) 1 year (Therapists)
Appropriateness Measure
Average score on two appropriateness items assessing appropriateness of time commitment and expected benefit, generated by the researchers. The first item was "My communication with patients will improve as a result of the training," and the second item was "The time commitment for the training was reasonable." Appropriateness refers to perceived fit of the training for the practice setting and patients. Scores are on a 1-5 scale from completely disagree to completely agree. A higher score indicates higher appropriateness. This is administered to providers immediately after the training.
Measured: Immediately following training
Feasibility Measure
Average score on the Feasibility of Intervention Measure (4 items). Feasibility refers to how well the training can be carried out within the agency/clinic setting. Scores are on a 1-5 scale from completely disagree to completely agree. All four items are averaged for a total score range of 1 to 5. A higher score indicates higher feasibility. This is administered to providers and therapists before and after the pilot year (1 year separation).
Measured: 1 year
Readiness to Change - Patient Preferences Subscale Score
Summed score on the Readiness to Change Assessment, patient preferences (4 items). The patient preferences subscale assesses site readiness to implement new trainings, based on perceived patient preferences. This measure is rated on a 1-5 scale from strongly disagree to strongly agree, with a sixth option for not applicable. Summed scores range from 4 to 20; High scores indicates greater acceptability. This is administered to providers and therapists before and after the pilot year (1 year separation).
Measured: 8 weeks, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start21 Feb 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Chris Mehus, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111886
- Sponsor's protocol ID
- Mehus, C
- Other IDs
- R34MH124690
- Status last verified
- Jan 2026
- First submitted
- 14 Oct 2021
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be deposited in NIH data repository.
Publications
Clerkin SM, Marks DJ, Policaro KL, Halperin JM. Psychometric properties of the Alabama parenting questionnaire-preschool revision. J Clin Child Adolesc Psychol. 2007 Mar;36(1):19-28. doi: 10.1080/15374410709336565.
PubMed 17206878Forgatch MS, Patterson GR, DeGarmo DS. Evaluating fidelity: predictive validity for a measure of competent adherence to the Oregon model of parent management training. Behav Ther. 2005;36(1):3-13. doi: 10.1016/s0005-7894(05)80049-8.
PubMed 16718302Helfrich CD, Li YF, Sharp ND, Sales AE. Organizational readiness to change assessment (ORCA): development of an instrument based on the Promoting Action on Research in Health Services (PARIHS) framework. Implement Sci. 2009 Jul 14;4:38. doi: 10.1186/1748-5908-4-38.
PubMed 19594942Lovejoy MC, Verda MR, Hays CE. Convergent and discriminant validity of measures of parenting efficacy and control. J Clin Child Psychol. 1997 Dec;26(4):366-76. doi: 10.1207/s15374424jccp2604_5.
PubMed 9418175Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Kamphaus, R. W. & Reynolds, C. R. (2015). BASC 3 Behavioral and Emotional Screening System Manual. Pearson PsychCorp.
Mehus, C., Ballard, J., Driscoll, J., Sargeant, L., & Exsted, M. (2025). Support and Guide: Observational Coding Scale Manual for Primary Care Clinician Conversations with Parents. University of Minnesota Digital Conservancy. Retrieved from https://hdl.handle.net/11299/276913
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Online Parenting Training
- ClinicalTrials.gov ID
- NCT05111886
- Acronym / sponsor ID
- Mehus, C
- Conditions
- Behavior Problem, Behavior, Child, Parents, Parent-Child Relations
- Keywords
- Parent program, GenerationPMTO, Primary care referral, pediatric referral, Primary care communication skills training, Online delivery, Brief interventions, Parents of 3-5 year old children, Behavior concerns, Parent behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Posted 4 Feb 2026
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 preventive interventions, such as GenerationPMTO (GenPMTO), effectively prevent behavioral health problems such as depression and conduct disorders. Unfortunately, parenting programs are not widely available nor well-attended. Pediatric primary care (PC) is a non-stigmatizing setting with nearly universal reach and, therefore, an ideal access point to increase availability. However, PC personnel are not trained to address behavioral health topics. Also, typical referral practices are inadequate. There is a need to develop effective referral practices in conjunction with increasing availability. 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 overcome these logistical barriers with more accessible programs. The long-term goal is to prevent significant behavioral health problems by increasing access to GenPMTO.
Detailed description
Specifically, the investigators propose engaging parents of 3 to 5-year-olds with moderate externalizing or internalizing symptoms through pediatric primary care (PC); PC personnel will refer parents to a community therapist who will deliver a novel brief eHealth (i.e. online video-chat) model of GenPMTO. Collaborating clinics are part of a Federally Qualified Health Center (FQHC), allowing for access to an under-served population of parents.
The primary objective of this project is to test a brief eHealth version of GenPMTO, delivered to parents online by community therapists (Aim 3). Brief online delivery can overcome logistical barriers, thereby increasing access while maintaining effectiveness. An additional objective is to develop (Aim 1) and test (Aim 2) a brief training for PC personnel and a referral process to equip them to effectively refer parents to eHealth GenPMTO, thereby increasing access to needed services through effective engagement in a trusted setting.
To achieve these objectives, the following aims will be completed. Aim 1 is a development phase to inform Aim 2 components. Aims 2 and 3 run concurrently in the study; the order of the aims reflects the patient flow.
Aim 1: Develop a referral process and a training for PC personnel by gathering mixed-method expert and stakeholder input and feedback. The investigators will present a proposed referral process and PC personnel training, and solicit feedback via the Nominal Group Technique from four expert groups: (1) researchers and implementers (n=6) with experience delivering other parenting interventions though primary care in the U.S., (2) primary care personnel (n=9) from FQHC primary care clinics, (3) personnel from British Columbia (n=6) who have implemented brief GenPMTO over the telephone with parents referred by primary care, and (4) parents (n=6) who receive care from an FQHC. One key question that will be addressed is which PC personnel (e.g., provider, nurse) is best suited to have the referring conversation with parents and receive the training.
Aim 2: Evaluate the referral process and conduct a pilot test of the PC personnel training within FQHC clinics. PC personnel (n=35) within two FQHC primary care clinics will be randomly assigned to receive communication skills training or a control condition. Control group personnel will receive a written description of the referral process but no training. Aim 2a: Using a sequential mixed-methods approach with PC personnel, the investigators will evaluate the acceptability and appropriateness of the referral process and the training. The investigators will also interview parents who do not complete a referral (n=10) to examine the acceptability of the referral process and identify remaining barriers to engagement. Aim 2b: The investigators will pilot test the effectiveness of the training to increase PC personnel's communication skills. The investigators will also use EHR data to pilot test the effect of the training on parent engagement in GenPMTO by comparing the rates of referral and engagement among patients who had an appointment with personnel in the training arm to those seeing control personnel.
Aim 3: Pilot test a brief, eHealth version of GenerationPMTO for moderate externalizing or internalizing symptoms. The personnel described in Aim 2 will refer parents to GenPMTO. Aim 3a: With the referred parents, the investigators will conduct a pilot RCT to examine change in parents' (n=60) parenting locus of control, self-reported parenting behaviors, and child externalizing and internalizing, all of which have been shown to predict later changes in child behavioral health outcomes. The investigators will examine the mediating effect of parenting changes on changes in child outcomes. These effect sizes will also be compared to effect sizes from other GenPMTO studies to determine if this preliminary assessment aligns with findings from other versions of GenPMTO. Aim 3b: Using a sequential mixed-methods approach, the investigators will assess the acceptability, feasibility, and appropriateness of brief, eHealth GenPMTO among therapists (n=15) and a sub-sample of parents (n=14).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Primary Care Personnel Training | Experimental | Behavioral: Communication Skills Training, Diagnostic Test: Survey of ExperiencePrimary care personnel within two Federally Qualified Health Center (FQHC) primary care clinics will be randomly assigned to receive communication skills training or a control condition. |
| Primary Care Personnel Training Control | Active comparator | Behavioral: Written Referral Process, Diagnostic Test: Survey of ExperiencePrimary care personnel within two Federally Qualified Health Center (FQHC) primary care clinics will be randomly assigned to receive communication skills training or a control condition. Control group personnel will receive a written description of the referral process but no training. |
| Parents eHealth GenPMTO | Experimental | Behavioral: eHealth GenPMTO, Diagnostic Test: Survey of ExperienceParents of 3- to 5-year-olds who receive services from primary care personnel at an Federally Qualified Health Center (FQHC) primary care clinic. Primary care personnel will refer parents of child with externalizing or internalizing behaviors to study therapists. Parents may be assigned to GenPMTO or control after referral. |
| Parents Control | Active comparator | Behavioral: One Session Education about Resources, Diagnostic Test: Survey of ExperienceParents of 3- to 5-year-olds who receive services from primary care personnel at an Federally Qualified Health Center (FQHC) primary care clinic. Primary care personnel will refer parents of child with externalizing or internalizing behaviors to study therapists. Parents may be assigned to GenPMTO or control after referral. |
| Therapists | Other | Diagnostic Test: Survey of ExperienceCommunity therapists trained to deliver GenPMTO. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Able to speak English
- Able to participate in the focus group
- Primary care personnel who are currently practicing in a collaborating clinic
- Therapists who are eligible for reimbursement from insurance and Medicaid
- Parents who are:
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Communication Skills TrainingThe training will focus on communication skills based on key constructs in the Health Belief Model and motivation/resistance research (described in section A3), the training will focus on: (1) conveying the benefits of parenting programs, (2) knowledge of and responses to common perceived barriers to attending parenting programs, and (3) skills and strategies to effectively motivate and refer parents in ways that are least likely to elicit resistance. The in-person training will last 60-90 minutes. It will include a theoretical background and experiential learning; each step of the referral process will be demonstrated and role-played. The investigators will work to ensure that personnel receive continuing education credits for the training. | Behavioural | Primary Care Personnel Training |
| eHealth GenPMTOThe GenPMTO is delivered over the phone (not online). This version is up to 6 sessions in length. This brief eHealth version of GenPMTO will be delivered through community therapists. The program will be delivered one-on-one (i.e., between a therapist and a parent or couple). | Behavioural | Parents eHealth GenPMTO |
| Written Referral ProcessA written summary and process map of the referral process, modeled on the Institute for Healthcare Improvement (IHI) 9-step process for "closing the loop" on referrals. | Behavioural | Primary Care Personnel Training Control |
| One Session Education about ResourcesOne online or phone conversation with the therapist in which the therapist guides the parent to the following resources: (a) a book, Raising Cooperative Kids, by GenPMTO co-developer Marion Forgatch; (b) a website, behaviorchecker.org, which includes behavioral "prescriptions" for common behavior issues; and (c) information about Early Childhood and Family Education classes, which are provided for free in Minnesota through public schools. | Behavioural | Parents Control |
| Survey of ExperienceSatisfaction with referral process | Diagnostic test | Parents Control, Parents eHealth GenPMTO, Primary Care Personnel Training, Primary Care Personnel Training Control, Therapists |
Primary outcome
Aim 3: Change in Behavioral Assessment System Child Score
Time frame: 8 weeks
Outcome is reported as the difference in pre- and post-intervention Externalizing Risk Scores, a subscale from the Behavior Assessment System for Children (3rd Edition, Parent Report Form - Preschool), which measures externalizing, internalizing, and adaptive behaviors. The Externalizing Risk Scores subscale measures externalizing behaviors the sum of using 9 items with a four-choice response format, for a raw Externalizing Risk Score range of 0-27. Higher scores indicate worse levels of externalizing behavior functioning. Scores of 0-10 are in the normal risk range, scores of 11-19 are elevated, and scores of 20 or above are extremely elevated. This is administered to parents before and after the intervention window (8 week separation). The change score was calculated as the value at 8 weeks minus value at baseline.
Aim 3: Change in Alabama Parenting Questionnaire
Time frame: 8 weeks
Outcome is reported as the difference in total scale score on the Alabama Parenting Questionnaire (preschool version) (Clerkin et al., 2007). This questionnaire contains 32 items rated on a 5-point scale ranging from "Never" to "Always." Total scores range from 32 to 160 with higher score indicating more involvement and positive parenting. This is administered to parents before and after the intervention window (8 week separation).
Aim 3: Change in Parent Locus of Control
Time frame: 8 weeks
Outcome is reported as the difference in total scores on the Parent Locus of Control measure (Lovejoy et al., 1997). This measure contains 24 items rated on a 5-point scale from strongly disagree (1) to strongly agree (5). Scores range from 24 to 120. High scores on the scale indicate an external locus of parenting control and low scores indicate an internal locus. This is administered to parents before and after the intervention window (8 week separation).
Aim 2: Percentage of Completed Referrals
Time frame: 1 year
Percentage of eligible appointments leading to successful referral.
Aim 2: Parent Attendance
Time frame: 1 year
For each referred caregiver, the number of sessions attended (0-6) was divided by the total possible number of sessions (6), to calculate the percent of sessions attended. The average was then calculated by referring clinician condition (training or control).
Aim 1: Fidelity of Implementation Rating System
Time frame: 1 year
Communication skills rating will be measured using the Support and Guide Observational Coding Scale of audio-recorded provider responses to clinical vignettes, a measure adapted from the Fidelity of Implementation Rating System. The scale measures the communication skills of supporting, guiding, confronting (reverse-coded), teaching (reverse-coded), and tone. Each of these components is averaged across the three vignettes on a 0-3 scale (support, guide, confront, teach), or a 0-2 scale (tone). A total scale is then summed for a total scale score range of 0-14, with higher scores indicating greater communication skills. These vignette prompts are administered to providers before and after the pilot year (1 year separation).
4 secondary outcomes
Intervention Acceptability Measure
Time frame: 8 weeks (Parents) 1 year (Therapists)
Appropriateness Measure
Time frame: Immediately following training
Feasibility Measure
Time frame: 1 year
Readiness to Change - Patient Preferences Subscale Score
Time frame: 8 weeks, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17206878Clerkin SM, Marks DJ, Policaro KL, Halperin JM. Psychometric properties of the Alabama parenting questionnaire-preschool revision. J Clin Child Adolesc Psychol. 2007 Mar;36(1):19-28. doi: 10.1080/15374410709336565.
- Background: PubMed 16718302Forgatch MS, Patterson GR, DeGarmo DS. Evaluating fidelity: predictive validity for a measure of competent adherence to the Oregon model of parent management training. Behav Ther. 2005;36(1):3-13. doi: 10.1016/s0005-7894(05)80049-8.
- Background: PubMed 19594942Helfrich CD, Li YF, Sharp ND, Sales AE. Organizational readiness to change assessment (ORCA): development of an instrument based on the Promoting Action on Research in Health Services (PARIHS) framework. Implement Sci. 2009 Jul 14;4:38. doi: 10.1186/1748-5908-4-38.
- Background: PubMed 9418175Lovejoy MC, Verda MR, Hays CE. Convergent and discriminant validity of measures of parenting efficacy and control. J Clin Child Psychol. 1997 Dec;26(4):366-76. doi: 10.1207/s15374424jccp2604_5.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- BackgroundKamphaus, R. W. & Reynolds, C. R. (2015). BASC 3 Behavioral and Emotional Screening System Manual. Pearson PsychCorp.
- BackgroundMehus, C., Ballard, J., Driscoll, J., Sargeant, L., & Exsted, M. (2025). Support and Guide: Observational Coding Scale Manual for Primary Care Clinician Conversations with Parents. University of Minnesota Digital Conservancy. Retrieved from https://hdl.handle.net/11299/276913
- Individual participant dataSharing planned: Yes. Data will be deposited in NIH data repository.
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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. This study is not recruiting at the moment.
Chris Mehus, PhD 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 Communication Skills Training, eHealth GenPMTO and Written Referral Process in people with Behavior Problem and Behavior, 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 10 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: finished, as of the sponsor's last update on 4 Feb 2026. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 3: Change in Behavioral Assessment System Child Score (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05111886, which also lists 7 linked publications.
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 4 Feb 2026.