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

February 28, 2025 updated by: University of Colorado, Denver

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Principal Investigator:
          • Jacob Holzman, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parenting Scale - Short Form
Time Frame: (1) Pre-treatment, (2) Up to 4 weeks after treatment began (Mid-Treatment), and (3) Up to 12 weeks after treatment began (Post-treatment)
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
Time Frame: (1) Pre-treatment, (2) Up to 4 weeks after treatment began (Mid-Treatment), and (3) Up to 12 weeks after treatment began (Post-treatment)
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
Time Frame: (1) Pre-treatment, (2) Up to 4 weeks after treatment began (Mid-Treatment), and (3) Up to 12 weeks after treatment began (Post-treatment)
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
Time Frame: (1) Pre-treatment and (3) Up to 12 weeks after treatment began (Post-treatment)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS Child Anger / Irritability
Time Frame: (1) Pre-treatment, (2) Up to 4 weeks after treatment began (Mid-Treatment), and (3) Up to 12 weeks after treatment began (Post-treatment)
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
Time Frame: (1) Pre-treatment and (3) Up to 12 weeks after treatment began (Post-treatment)
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
Time Frame: (1) Pre-treatment and (3) Up to 12 weeks after treatment began (Post-treatment)
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
Time Frame: (3) Up to 12 weeks after treatment began (Post-treatment)
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
Time Frame: (3) Up to 12 weeks after treatment began (Post-treatment)
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
Time Frame: (3) Up to 12 weeks after treatment began (Post-treatment)
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
Time Frame: (3) Up to 12 weeks after treatment began (Post-treatment)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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