Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34MH124690 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication Skills Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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). | 8 weeks |
| Aim 2: Percentage of Completed Referrals | Percentage of eligible appointments leading to successful referral. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Participants are eligible for Aim 1 if they are:
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
Parents who are:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chris Mehus, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17206878 | Background | 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. | |
| 16718302 | Background | Forgatch 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. |
Not provided
Not provided
Data will be deposited in NIH data repository.
3 years
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Primary Care Personnel Training | 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. Communication Skills Training: 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. Survey of Experience: Satisfaction with referral process |
| FG001 | Primary Care Personnel Training Control | 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. Written Referral Process: 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. Survey of Experience: Satisfaction with referral process |
| FG002 | Parents eHealth GenPMTO | 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. eHealth GenPMTO: 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). Survey of Experience: Satisfaction with referral process |
| FG003 | Parents Control | 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. One Session Education about Resources: 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 Experience: Satisfaction with referral process |
| FG004 | Therapists | Community therapists trained to deliver GenPMTO. Survey of Experience: Satisfaction with referral process |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Primary Care Personnel Training | 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. Communication Skills Training: 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. Survey of Experience: Satisfaction with referral process |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The 'Number analyzed' reported for age reflects the total number who reported their age (e.g., 14 clinicians in the experimental condition of 21 total, 12 clinicians in the control condition of 14 total, 23 parent participants in the eGen condition of 23 total, 20 participants in the control condition of 20 total, and 16 participants in the therapist condition of 16 total. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Care Personnel Training | 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. Communication Skills Training: 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. Survey of Experience: Satisfaction with referral process |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Mehus, PhD, LMFT | University of Minnesota | 651-785-3660 | CJMehus@umn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2021 | Sep 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2021 | Sep 24, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Therapists | Other | Community therapists trained to deliver GenPMTO. |
|
|
| eHealth GenPMTO | Behavioral | 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 Process | Behavioral | 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 Resources | Behavioral | 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 Experience | Diagnostic Test | Satisfaction with referral process |
|
| 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). | 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). | 1 year |
| 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. | 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). | 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). | 8 weeks, 1 year |
| 19594942 | Background | Helfrich 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. |
| 9418175 | Background | Lovejoy 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. |
| 28851459 | Background | Weiner 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. |
| Background | Kamphaus, R. W. & Reynolds, C. R. (2015). BASC 3 Behavioral and Emotional Screening System Manual. Pearson PsychCorp. |
| Background | 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 |
| BG001 | Primary Care Personnel Training Control | 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. Written Referral Process: 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. Survey of Experience: Satisfaction with referral process |
| BG002 | Parents eHealth GenPMTO | 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. eHealth GenPMTO: 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). Survey of Experience: Satisfaction with referral process |
| BG003 | Parents Control | 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. One Session Education about Resources: 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 Experience: Satisfaction with referral process |
| BG004 | Therapists | Community therapists trained to deliver GenPMTO. Survey of Experience: Satisfaction with referral process |
| BG005 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | The 'Number analyzed' reported for sex reflects the total number who reported their sex (e.g., 16 clinicians in the experimental condition of 21 total, 12 clinicians in the control condition of 14 total, 23 parent participants in the eGen condition of 23 total, 20 participants in the control condition of 20 total, and 15 participants in the therapist condition of 16 total. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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.
eHealth GenPMTO: 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).
Survey of Experience: Satisfaction with referral process
| OG001 | Parents Control | 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. One Session Education about Resources: 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 Experience: Satisfaction with referral process |
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Primary | 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). | In the active comparator: parents control condition, 1 person was missing data (1/16) | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Primary | Aim 2: Percentage of Completed Referrals | Percentage of eligible appointments leading to successful referral. | Posted | Mean | Standard Deviation | % of appts leading to completed referral | 1 year |
|
|
|
| Primary | 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). | The percent of sessions attended can only be calculated for clinicians who made at least one referral. Data is analyzed for 12 primary care clinicians in the training condition and 7 primary care clinicians in the control condition. This reflects that 9/21 clinicians in the training condition did not make any referrals, and 7/14 clinicians in the control condition did not make any referrals | Posted | Mean | Standard Deviation | percent | 1 year |
|
|
|
| Primary | 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). | Audio-recorded responses were missing for 10 of the 21 primary care clinicians in the experimental condition, and 9 of the 14 primary care clinicians in the control condition | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| Secondary | 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). | Acceptability data was missing for 11 of the 21 primary care clinicians in the experimental condition, and 6 of the 14 primary care clinicians in the control condition. Acceptability data was missing for 5 of the parents in the experimental condition, and 10 of the parents in the control condition. Acceptability data was not missing for any of the therapists. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks (Parents) 1 year (Therapists) |
|
|
|
| Secondary | 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. | Appropriateness was only assessed among Primary Care Clinicians in the experimental condition. Of these 21 clinicians, 13 reported on the acceptability. | Posted | Mean | Standard Deviation | score on a scale | Immediately following training |
|
|
|
| Secondary | 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). | Feasibility was only assessed among Primary Care Clinicians (both arms) and Therapists. Responses to this measure were missing for 11 of the 21 primary care clinicians in the experimental condition, for 6 of the 14 primary care clinicians in the control condition, and for 1 of the 16 therapists. It was not assessed of parents in either arm (active comparator or experimental). | Posted | Mean | Standard Deviation | score on a scale | 1 year |
|
|
|
| Secondary | 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). | Responses to this measure were missing for 10 of the 21 primary care clinicians in the experimental condition, for 2 of the 14 primary care clinicians in the control condition, and for 3 of the 16 therapists. It was not assessed of parents in either arm (active comparator or experimental). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks, 1 year |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Primary Care Personnel Training Control | 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. Written Referral Process: 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. Survey of Experience: Satisfaction with referral process | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Parents eHealth GenPMTO | 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. eHealth GenPMTO: 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). Survey of Experience: Satisfaction with referral process | 0 | 23 | 0 | 23 | 0 | 23 |
| EG003 | Parents Control | 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. One Session Education about Resources: 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 Experience: Satisfaction with referral process | 0 | 20 | 0 | 20 | 0 | 20 |
| EG004 | Therapists | Community therapists trained to deliver GenPMTO. Survey of Experience: Satisfaction with referral process | 0 | 16 | 0 | 16 | 0 | 16 |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|