Stop, Focus, Plan, and Change: Predicting Parent and Child Responses to a Brief, Telehealth Parent Training

Stop, Focus, Plan, and Change: A Translational Approach to Predict Parent and Child Responses to a Brief, Telehealth Parent Training

This study will look at who does not improve after doing a behavioral parent training program briefly through telehealth. It will also study ways to make the intervention better for those that do not improve.

Study Overview

• Status: Recruiting
• Conditions: Stress; Parenting; Irritable Mood; Behavioral Problem
• Intervention / Treatment: Behavioral: Brief Behavioral Parenting Program

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela Peralta Reyes, BA; Phone Number: 303-724-7093; Email: gabriela.peraltareyes@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Principal Investigator: Jacob Holzman, PhD
      • Contact: Gabriela Peralta Reyes; Phone Number: 303-724-7093; Email: gabriela.peraltareyes@ucdenver.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parent speaks English or Spanish
• Parent has access to Internet
• Parent intends to complete treatment
• Parent reports child has elevated externalizing concerns

Exclusion Criteria:

• Child is a ward of the state
• Child diagnosed with severe medical or nonverbal developmental disability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Behavioral Parent Training Program; The behavioral parent training intervention is delivered briefly through telehealth. It will be the only arm. It will be the only intervention received by participants in the context of this study.	Behavioral: Brief Behavioral Parenting Program; The brief behavioral parenting program is a 6 session, group-based behavioral parent training program. The components include support-building, parenting strategy education, and actively practicing parenting strategies. It is delivered through telehealth.; Other Names: Behavioral Parent TRaining

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Scale - Short Form	The Parenting Scale Short Form measures parenting practices, including emotional over-reactivity and lax discipline use. Possible scores on the emotional over-reactivity scale range from 4 to 28, with higher scores indicating more emotional reactivity. Possible scores on the lax discipline scale range from 4 to 28, with higher scores indicating more lax discipline use.	(1) Pre-treatment, (2) Up to 4 weeks after treatment began (Mid-Treatment), and (3) Up to 12 weeks after treatment began (Post-treatment)
Caregiver Strain Questionnaire - Short Form	The Caregiver Strain Questionnaire - Short Form measures parenting stress. Possible scores range from 7 to 35, with higher scores indicating more parenting stress.	(1) Pre-treatment, (2) Up to 4 weeks after treatment began (Mid-Treatment), and (3) Up to 12 weeks after treatment began (Post-treatment)
Eyberg Child Behavior Inventory	The Eyberg Child Behavior Inventory measures parent-reported child behavioral concerns. Possible scores range from 36 to 252, with higher scores indicating more child behaviors concerns.	(1) Pre-treatment, (2) Up to 4 weeks after treatment began (Mid-Treatment), and (3) Up to 12 weeks after treatment began (Post-treatment)
Sutter Eyberg Student Behavior Inventory	The Sutter Eyberg Student Behavior Inventory measures teacher-reported child behavioral concerns. Possible scores range from 36 to 266, with higher scores indicating more child behaviors concerns.	(1) Pre-treatment and (3) Up to 12 weeks after treatment began (Post-treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Child Anger / Irritability	The PROMIS Child Anger / Irritability survey measures child irritability. Possible scores range from 8 to 40, with higher scores indicating more child irritability.	(1) Pre-treatment, (2) Up to 4 weeks after treatment began (Mid-Treatment), and (3) Up to 12 weeks after treatment began (Post-treatment)
Parent-Child Interaction Coding System	The Parent-Child Interaction Coding System (PARCHISY) is an observational coding system measuring parenting behavior and affect. Observation are coded using global ratings on a 1 (not observed) to 7 (frequently observed) scale.	(1) Pre-treatment and (3) Up to 12 weeks after treatment began (Post-treatment)
Dyadic Parent-Child Interaction Coding System	The dyadic parent-child interaction coding system is an observational coding system measuring parenting behaviors. Observations are coding using event-based ratings to tally the number of specific parenting behaviors observed within the parent-child interaction task.	(1) Pre-treatment and (3) Up to 12 weeks after treatment began (Post-treatment)
Retrospective Post-Pre Change: Harsh Parenting	The retrospective post-pre change: harsh parenting questionnaire measures parental perceptions of change in harsh parenting (e.g., yelling) over the course of the intervention. One item measures the frequency of harsh parenting before the intervention and another item measures the frequency of harsh parenting after the intervention. Each item ranges from 0 to 100 with higher scores indicating more harsh parenting at the respective time point.	(3) Up to 12 weeks after treatment began (Post-treatment)
Retrospective Post-Pre Change: Parenting Stress	The retrospective post-pre change: parenting stress questionnaire measures parental perceptions of change in parenting stress over the course of the intervention. One item measures the frequency of parenting stress before the intervention and another item measures the frequency of parenting stress after the intervention. Each item ranges from 0 to 100 with higher scores indicating more parenting stress at the respective time point.	(3) Up to 12 weeks after treatment began (Post-treatment)
Retrospective Post-Pre Change: Child Externalizing Concerns	The retrospective post-pre change: child behavioral concerns questionnaire measures parental perceptions of change in child behavioral concerns over the course of the intervention. One item measures the frequency of child behavioral concerns before the intervention and another item measures the frequency of child behavioral concerns after the intervention. Each item ranges from 0 to 100 with higher scores indicating more child behavioral concerns at the respective time point.	(3) Up to 12 weeks after treatment began (Post-treatment)
Retrospective Post-Pre Change: Child Irritability	The retrospective post-pre change: child irritability questionnaire measures parental perceptions of change in child irritability over the course of the intervention. One item measures the frequency of child irritability before the intervention and another item measures the frequency of child irritability after the intervention. Each item ranges from 0 to 100 with higher scores indicating more child irritability at the respective time point.	(3) Up to 12 weeks after treatment began (Post-treatment)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Irritability; Parenting stress; Parenting practices; Behavioral Concerns
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: 21-3184; 1K23MH134189-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No