Effectiveness of an Online Parenting Training

Not Applicable

Completed

• Conditions: Behavior, Child; Parent-Child Relations; Parents; Behavior Problem
• Interventions: Diagnostic Test: Survey of Experience; Behavioral: Communication Skills Training; Behavioral: eHealth GenPMTO; Behavioral: Written Referral Process; Behavioral: One Session Education about Resources

• Registration Number: NCT05111886
• Lead Sponsor: University of Minnesota

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).

Study Timeline

• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-08
• Study Start: 2022-02-21
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapists	Survey of Experience	Community therapists trained to deliver GenPMTO.
Primary Care Personnel Training	Communication Skills 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.
Parents eHealth GenPMTO	Survey of Experience	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	Survey of Experience	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 eHealth GenPMTO	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.
Primary Care Personnel Training	Survey of Experience	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	Written Referral Process	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.
Primary Care Personnel Training Control	Survey of Experience	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 Control	One Session Education about Resources	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.

Primary Outcome Measures

Name	Time	Method
Aim 2: Number of Completed Referrals	1 year	This is defined as the number of parents who agree to begin treatment with the therapist after a referral from a primary care provider.
Aim 2: Parent Attendance	1 year	Parent attendance will be reported as the percent of sessions attended.
Aim 3: Change in Behavioral Assessment System Child Score	8 weeks	Outcome is reported as the difference in pre- and post-intervention t-scores (unitless measure) on the BASC - Behavior Assessment System for Children (3rd Edition, Parent Report Form - Preschool) (Reynolds; Kamphaus, 2015). The assessment includes 29 items and uses a four-choice response format. Higher scores indicate problematic levels of functioning. This is administered to parents before and after the intervention window (8 week separation).
Aim 3: Change in Alabama Parenting Questionnaire	8 weeks	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).
Aim 1: Fidelity of Implementation Rating System	1 year	Communication skills rating will be measured by the total score of an adapted Fidelity of Implementation Rating System of audio-recorded provider responses to clinical vignettes. Each dimension uses a 9-point scale, with higher scores indicating greater communication skills. This vignette prompts are administered to providers before and after the pilot year (1 year separation).
Aim 3: Change in Parent Locus of Control	8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Intervention Acceptability Measure	1 year	Average score on the Acceptability of intervention Measure (4 items) (Weiner et al., 2017). Scores are on a scale 1-5 scale from completely disagree to completely agree. 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).
Appropriateness Measure	1 year	Average score on the Intervention Appropriateness Measure(Weiner et al., 2017). Scores are on a 1-5 scale from completely disagree to completely agree. A higher score indicates higher appropriateness. 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).
Feasibility Measure	1 year	Average score on the Feasibility of Intervention Measure (4 items) (Weiner et al., 2017). Scores are on a 1-5 scale from completely disagree to completely agree. A higher score indicates higher feasibility. 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).
Readiness to Change - Patient Preferences Subscale Score	8 weeks, 1 year	Average score on the Readiness to Change Assessment, patient preferences (4 items)(Helfrich, Li; Sharp, 2009). This measure is rated on a 1-5 scale from strongly disagree to strongly agree, with a sixth option for not applicable. High scores indicates greater acceptability. This is administered to providers and therapists before and after the pilot year (1 year separation).

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States