An interventional study of Communication Skills Training and eHealth GenPMTO in Behavior Problem, Behavior, Child and Parents, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 16 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by University of Minnesota · Not applicable, Interventional, and Other
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.
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).
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's enrollment of 94 is close to the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible for Aim 1 if they are:
Participants are eligible for Aim 2 if they are:
Parents who are:
Exclusion Criteria:
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.
Behavioral: Communication Skills Training · Diagnostic Test: Survey of Experience
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.
Behavioral: Written Referral Process · Diagnostic Test: Survey of Experience
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.
Behavioral: eHealth GenPMTO · Diagnostic Test: Survey of Experience
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.
Behavioral: One Session Education about Resources · Diagnostic Test: Survey of Experience
Community therapists trained to deliver GenPMTO.
Diagnostic Test: Survey of Experience
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.
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).
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 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.
Satisfaction with referral process
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.
Time frame: 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).
Time frame: 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).
Time frame: 8 weeks
Aim 2: Percentage of Completed Referrals
Percentage of eligible appointments leading to successful referral.
Time frame: 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).
Time frame: 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).
Time frame: 1 year
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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 8 weeks, 1 year
| Milestone | Primary Care Personnel Training | Primary Care Personnel Training Control | Parents eHealth GenPMTO | Parents Control | Therapists |
|---|---|---|---|---|---|
| Started | 21 | 14 | 23 | 20 | 16 |
| Completed | 21 | 14 | 23 | 16 | 16 |
| Not completed | 0 | 0 | 0 | 4 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 4 | 0 |
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.
| score on a scale | Parents eHealth GenPMTO | Parents Control |
|---|---|---|
| Aim 3: Change in Behavioral Assessment System Child Score | -3.17 ± 7.51 | 0.13 ± 8.76 |
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).
| score on a scale | Parents eHealth GenPMTO | Parents Control |
|---|---|---|
| Aim 3: Change in Alabama Parenting Questionnaire | -0.65 ± 1.94 | -0.13 ± 1.41 |
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).
| score on a scale | Parents eHealth GenPMTO | Parents Control |
|---|---|---|
| Aim 3: Change in Parent Locus of Control | 3.78 ± 8.05 | 2.47 ± 7.98 |
Percentage of eligible appointments leading to successful referral.
| % of appts leading to completed referral | Primary Care Personnel Training | Primary Care Personnel Training Control |
|---|---|---|
| Aim 2: Percentage of Completed Referrals | 0.34 ± 0.94 | 0.15 ± 0.37 |
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).
| percent | Primary Care Personnel Training | Primary Care Personnel Training Control |
|---|---|---|
| Aim 2: Parent Attendance | 22.4 ± 39.0 | 20.0 ± 36.0 |
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).
| score on a scale | Primary Care Personnel Training | Primary Care Personnel Training Control |
|---|---|---|
| Aim 1: Fidelity of Implementation Rating System | 11.26 ± 4.53 | 8.9 ± 2.56 |
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).
| score on a scale | Primary Care Personnel Training | Primary Care Personnel Training Control | Parents eHealth GenPMTO | Parents Control | Therapists |
|---|---|---|---|---|---|
| Intervention Acceptability Measure | 3.3 ± 0.88 | 3.25 ± 0.89 | 4.24 ± 0.8 | 3.13 ± 1.2 | 4.23 ± 0.72 |
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.
| score on a scale | Primary Care Personnel Training |
|---|---|
| Appropriateness Measure | 4.03 ± 0.43 |
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).
| score on a scale | Primary Care Personnel Training | Primary Care Personnel Training Control | Therapists |
|---|---|---|---|
| Feasibility Measure | 3.4 ± 0.74 | 3.44 ± 0.73 | 4.24 ± 0.40 |
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).
| score on a scale | Primary Care Personnel Training | Primary Care Personnel Training Control | Therapists |
|---|---|---|---|
| Readiness to Change - Patient Preferences Subscale Score | 17.09 ± 1.58 | 17.25 ± 1.86 | 16.23 ± 1.87 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary Care Personnel Training | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Primary Care Personnel Training Control | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Parents eHealth GenPMTO | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Parents Control | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Therapists | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Categorical(Participants) | Primary Care Personnel Training | Primary Care Personnel Training Control | Parents eHealth GenPMTO | Parents Control | Therapists | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 12 | 23 | 19 | 16 | 83 |
| >=65 years | 1 | 0 | 0 | 1 | 0 | 2 |
| Sex: Female, Male(Participants) | Primary Care Personnel Training | Primary Care Personnel Training Control | Parents eHealth GenPMTO | Parents Control | Therapists | Total |
|---|---|---|---|---|---|---|
| Female | 14 | 8 | 22 | 19 | 15 | 78 |
| Male | 2 | 4 | 1 | 1 | 0 | 8 |
| Race (NIH/OMB)(Participants) | Primary Care Personnel Training | Primary Care Personnel Training Control | Parents eHealth GenPMTO | Parents Control | Therapists | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 2 | 0 | 0 | 2 |
| Asian | 2 | 2 | 0 | 0 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 | 4 | 4 | 12 |
| White | 11 | 8 | 10 | 7 | 6 | 42 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 3 | 9 | 9 | 5 | 33 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be deposited in NIH data repository.
Supporting information: Statistical analysis plan
Time frame: 3 years
Ran from Feb 2022 to primary completion in Jun 2024, 27 months.
Results were first posted in Feb 2026, 1 year 8 months after primary completion.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 27 months is close to that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.