Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
94 participants
INTERVENTIONAL
2022-02-21
2024-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of a Multi-Component Evidence-Based Parent Training Program in Reducing Child Maltreatment
NCT00595010
Online Parent Training for Children With Behavior Disorders
NCT01861158
Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain
NCT01496378
Internet-based Universal Parent Training as a Booster to PATHS®: Parent Web
NCT05172297
The Impact of Parent Training on the Child's Health Services
NCT03704974
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Survey of Experience
Satisfaction with referral process
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.
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.
Survey of Experience
Satisfaction with referral process
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.
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.
Survey of Experience
Satisfaction with referral process
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).
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
Therapists
Community therapists trained to deliver GenPMTO.
Survey of Experience
Satisfaction with referral process
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
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).
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Parents who are:
1. Referred to a therapist by their providers
2. Have the ability to speak English or Spanish, and
3. Are a primary caregiver for a child between the ages of 3 and 5 years old
Exclusion Criteria
16 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
University of Minnesota
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chris Mehus, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Minnesota
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Kamphaus, 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
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Mehus, C
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.