Behavioral ProblemNCT06505980
Stop, Focus, Plan, and Change: Predicting Parent and Child Responses to a Brief, Telehealth Parent Training
A study testing Brief Behavioral Parenting Program in people with Behavioral Problem and Irritable Mood, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Problem, Irritable Mood, Parenting
- What is being tested?
- Brief Behavioral Parenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2024to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent speaks English or Spanish
- Parent has access to Internet
- Parent intends to complete treatment
- Parent reports child has elevated externalizing concerns
Who cannot join
- Child is a ward of the state
- Child diagnosed with severe medical or nonverbal developmental disability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Gabriela Peralta Reyes, 303-724-7093, gabriela.peraltareyes@ucdenver.edu
Jacob Holzman, PhD
About this study
Official title: 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.
- Conditions
- Behavioral Problem, Irritable Mood, Parenting, Stress
- Being tested
- Brief Behavioral Parenting Program
- Keywords
- Behavioral Concerns, Irritability, Parenting stress, Parenting practices
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Parenting ProgramBehavioural
Also called Behavioral Parent TRaining
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Parent Training Program | Other | 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. Receives: Behavioral: Brief Behavioral Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (1) Pre-treatment and (3) Up to 12 weeks after treatment began (Post-treatment)
Secondary outcomes (7)
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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (3) Up to 12 weeks after treatment began (Post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start18 Oct 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral ProblemStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505980
- Sponsor's protocol ID
- 21-3184
- Other IDs
- 1K23MH134189-01A1
- Status last verified
- Feb 2025
- First submitted
- 18 Jun 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop, Focus, Plan, and Change: A Translational Approach to Predict Parent and Child Responses to a Brief, Telehealth Parent Training
- ClinicalTrials.gov ID
- NCT06505980
- Acronym / sponsor ID
- 21-3184
- Conditions
- Behavioral Problem, Irritable Mood, Parenting, Stress
- Keywords
- Behavioral Concerns, Irritability, Parenting stress, Parenting practices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Parent Training Program | Other | Behavioral: Brief Behavioral Parenting ProgramThe 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parent speaks English or Spanish
- Parent has access to Internet
- Parent intends to complete treatment
- Parent reports child has elevated externalizing concerns
Key exclusion criteria (2 listed)
- Child is a ward of the state
- Child diagnosed with severe medical or nonverbal developmental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Behavioral Parenting ProgramAlso: Behavioral Parent TRainingThe 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. | Behavioural | Behavioral Parent Training Program |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
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)
Parent-Child Interaction Coding System
Time frame: (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)
Retrospective Post-Pre Change: Harsh Parenting
Time frame: (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)
Retrospective Post-Pre Change: Child Externalizing Concerns
Time frame: (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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Parenting Program in people with Behavioral Problem and Irritable Mood, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Peralta Reyes, BA (303-724-7093, gabriela.peraltareyes@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.