Clinical trial NCT05111886: Effectiveness of an Online Parenting Training
Official title: Effectiveness of an Online Parenting Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Problem
Behavior, Child
Parents
Parent-Child Relations
Keywords: Parent program, GenerationPMTO
Primary care referral, pediatric referral
Primary care communication skills training
Online delivery
Brief interventions
Parents of 3-5 year old children
Behavior concerns
Parent behavior
Child externalizing, child internalizing
Acceptability, appropriateness, feasibility
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 94
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Aim 3: Change in Behavioral Assessment System Child Score
timeFrame: 8 weeks
measure: Aim 3: Change in Alabama Parenting Questionnaire
timeFrame: 8 weeks
measure: Aim 3: Change in Parent Locus of Control
timeFrame: 8 weeks
measure: Aim 2: Number of Completed Referrals
timeFrame: 1 year
measure: Aim 2: Parent Attendance
timeFrame: 1 year
measure: Aim 1: Fidelity of Implementation Rating System
timeFrame: 1 year
Secondary outcomes:
measure: Intervention Acceptability Measure
timeFrame: 1 year
measure: Appropriateness Measure
timeFrame: 1 year
measure: Feasibility Measure
timeFrame: 1 year
measure: Readiness to Change - Patient Preferences Subscale Score
timeFrame: 8 weeks, 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Chris Mehus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.