NCT06505980

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Oct 2024Mar 2029

First Submitted

Initial submission to the registry

June 18, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 18, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

June 18, 2024

Last Update Submit

February 28, 2025

Conditions

Behavioral ProblemIrritable MoodParentingStress

Keywords

Behavioral ConcernsIrritabilityParenting stressParenting practices

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • PROMIS Child Anger / 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

    (1) Pre-treatment and (3) Up to 12 weeks after treatment began (Post-treatment)

  • Dyadic Parent-Child Interaction Coding System

    (1) Pre-treatment and (3) Up to 12 weeks after treatment began (Post-treatment)

  • Retrospective Post-Pre Change: Harsh Parenting

    (3) Up to 12 weeks after treatment began (Post-treatment)

  • Retrospective Post-Pre Change: Parenting Stress

    (3) Up to 12 weeks after treatment began (Post-treatment)

  • +2 more secondary outcomes

Study Arms (1)

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.

Behavioral: Brief Behavioral Parenting Program

Interventions

Brief Behavioral Parenting ProgramBEHAVIORAL

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.

Also known as: Behavioral Parent TRaining
Behavioral Parent Training Program

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Behavior

Central Study Contacts

Gabriela Peralta Reyes, BA

CONTACT

303-724-7093gabriela.peraltareyes@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Coders will be masked to treatment time-point when measuring observed outcomes.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2024

First Posted

July 17, 2024

Study Start

October 18, 2024

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

March 30, 2029

Last Updated

March 4, 2025

Record last verified: 2025-02

Locations

US(1)