Effectiveness of an Online Parenting Training

Parent-Child Relations Clinical Trial

Official title:

Effectiveness of an Online Parenting Training

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05111886
• Other study ID #: Mehus, C
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 21, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 146
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior Problem
• Behavior, Child
• Parent-Child Relations
• Parents
• Problem Behavior

Intervention

Behavioral:
• 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.
• 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.

Diagnostic Test:
• Survey of Experience
Satisfaction with referral process

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aim 3: Change in Behavioral Assessment System Child Score	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).	8 weeks
Primary	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
Primary	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
Primary	Aim 2: Number of Completed Referrals	This is defined as the number of parents who agree to begin treatment with the therapist after a referral from a primary care provider.	1 year
Primary	Aim 2: Parent Attendance	Parent attendance will be reported as the percent of sessions attended.	1 year
Primary	Aim 1: Fidelity of Implementation Rating System	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).	1 year
Secondary	Intervention Acceptability Measure	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).	1 year
Secondary	Appropriateness Measure	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).	1 year
Secondary	Feasibility Measure	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).	1 year
Secondary	Readiness to Change - Patient Preferences Subscale Score	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).	8 weeks, 1 year