NCT05111886

Brief Summary

Child and adolescent behavioral health problems are related to the leading causes of youth morbidity and mortality. Parent-focused preventive interventions, such as GenerationPMTO (GenPMTO), effectively prevent behavioral health problems such as depression and conduct disorders. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

October 14, 2021

Results QC Date

September 25, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

Parent program, GenerationPMTOPrimary care referral, pediatric referralPrimary care communication skills trainingOnline deliveryBrief interventionsParents of 3-5 year old childrenBehavior concernsParent behaviorChild externalizing, child internalizingAcceptability, appropriateness, feasibility

Outcome Measures

Primary Outcomes (6)

  • 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.

    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

Secondary Outcomes (4)

  • Intervention Acceptability Measure

    8 weeks (Parents) 1 year (Therapists)

  • Appropriateness Measure

    Immediately following training

  • Feasibility Measure

    1 year

  • Readiness to Change - Patient Preferences Subscale Score

    8 weeks, 1 year

Study Arms (5)

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.

Behavioral: Communication Skills TrainingDiagnostic Test: Survey of Experience

Primary Care Personnel Training Control

ACTIVE COMPARATOR

Primary care personnel within two Federally Qualified Health Center (FQHC) primary care clinics will be randomly assigned to receive communication skills training or a control condition. Control group personnel will receive a written description of the referral process but no training.

Behavioral: Written Referral ProcessDiagnostic Test: Survey of Experience

Parents eHealth GenPMTO

EXPERIMENTAL

Parents of 3- to 5-year-olds who receive services from primary care personnel at an Federally Qualified Health Center (FQHC) primary care clinic. Primary care personnel will refer parents of child with externalizing or internalizing behaviors to study therapists. Parents may be assigned to GenPMTO or control after referral.

Behavioral: eHealth GenPMTODiagnostic Test: Survey of Experience

Parents Control

ACTIVE COMPARATOR

Parents of 3- to 5-year-olds who receive services from primary care personnel at an Federally Qualified Health Center (FQHC) primary care clinic. Primary care personnel will refer parents of child with externalizing or internalizing behaviors to study therapists. Parents may be assigned to GenPMTO or control after referral.

Behavioral: One Session Education about ResourcesDiagnostic Test: Survey of Experience

Therapists

OTHER

Community therapists trained to deliver GenPMTO.

Diagnostic Test: Survey of Experience

Interventions

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
eHealth GenPMTOBEHAVIORAL

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 eHealth GenPMTO

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.

Primary Care Personnel Training Control

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.

Parents Control
Survey of ExperienceDIAGNOSTIC_TEST

Satisfaction with referral process

Parents ControlParents eHealth GenPMTOPrimary Care Personnel TrainingPrimary Care Personnel Training ControlTherapists

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Referred to a therapist by their providers
  • Have the ability to speak English or Spanish, and
  • Are a primary caregiver for a child between the ages of 3 and 5 years old

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (7)

  • 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.

    PMID: 17206878BACKGROUND
  • 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.

    PMID: 16718302BACKGROUND
  • 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.

    PMID: 19594942BACKGROUND
  • 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.

    PMID: 9418175BACKGROUND
  • 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.

    PMID: 28851459BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Mental DisordersChild Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Christopher Mehus, PhD, LMFT
Organization
University of Minnesota

Study Officials

  • Chris Mehus, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2021

First Posted

November 8, 2021

Study Start

February 21, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

February 4, 2026

Results First Posted

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Data will be deposited in NIH data repository.

Shared Documents
SAP
Time Frame
3 years

Locations