Effectiveness of an Online Parenting Training

NCT ID: NCT05111886

Last Updated: 2026-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-21

Study Completion Date

2024-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Behavior Problem Behavior, Child Parents Parent-Child Relations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

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.

Group Type EXPERIMENTAL

Survey of Experience

Intervention Type DIAGNOSTIC_TEST

Satisfaction with referral process

Communication Skills Training

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Survey of Experience

Intervention Type DIAGNOSTIC_TEST

Satisfaction with referral process

Written Referral Process

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Survey of Experience

Intervention Type DIAGNOSTIC_TEST

Satisfaction with referral process

eHealth GenPMTO

Intervention Type 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).

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.

Group Type ACTIVE_COMPARATOR

One Session Education about Resources

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Satisfaction with referral process

Therapists

Community therapists trained to deliver GenPMTO.

Group Type OTHER

Survey of Experience

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type BEHAVIORAL

Survey of Experience

Satisfaction with referral process

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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
* 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

* None
Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

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

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

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.

Reference Type BACKGROUND
PMID: 17206878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16718302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19594942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9418175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28851459 (View on PubMed)

Kamphaus, R. W. & Reynolds, C. R. (2015). BASC 3 Behavioral and Emotional Screening System Manual. Pearson PsychCorp.

Reference Type 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

Reference Type BACKGROUND

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R34MH124690

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Mehus, C

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Promotion of Successful Parenting
NCT03808987 COMPLETED NA
SBIR/ STTR Family Check-up Online
NCT06876246 RECRUITING NA
Preventing Child Abuse in Infants
NCT00000382 COMPLETED PHASE3
Parenting Mindfully Study II
NCT05370768 ACTIVE_NOT_RECRUITING NA
Middle School Success Over Stress
NCT05117099 COMPLETED NA