NCT07505381

Brief Summary

HOT DOCS and DOCS K-5 are group-delivered behavioral parent training interventions for caregivers of children ages 0-12 years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Oct 2018

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 Progress77%
Oct 2018Sep 2028

Study Start

First participant enrolled

October 2, 2018

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

March 9, 2026

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Eyberg Child Behavior Inventory

    Child behavior problems are analyzed at pre- and post-intervention using the Intensity scale of the Eyberg Child Behavior Inventory (ECBI). Caregivers used a 7-point Likert scale (1 = never to 7 = always) to rate intensity of child problem behaviors (e.g., aggression, whining, noncompliance). Intensity scores range from 36 to 252, and a score of 131 or higher indicates a clinically significant behavior problem and higher scores = worse outcome. The ECBI has high test-retest reliability, internal consistency reliability, and inter-rater reliability (αs = .75, .93, and .79, respectively) and strong content and construct validity.

    From enrollment to the end of treatment at 6 weeks.

  • DOCS Parenting Stress Measure

    Parenting stress is analyzed using the DOCS Parenting Stress Measure at pre- and post-intervention (DOCS PSM, adapted from the Autism Parenting Stress Index. The APSI was designed to measure caregivers' ability to cope with the demands of raising a child with autism and includes 13 items related to daily living, development, and adaptation. The adaptation involved slightly re-wording some items (e.g., changing your child's diet to your child's feeding difficulties) and adding four items on the impact parenting has on other aspects of the caregiver's life, like the time and financial resources parenting takes. Like the ASPI, the 17-item DOCS PSM uses Likert-scale responses ranging from 0 = not stressful to 4 = so stressful sometimes you feel you can't cope with total scores ranging from 0-68, higher scores = more stress and worse outcome. The ASPI has demonstrated good internal consistency and test-retest reliability (αs = .83, .88, respectively).

    From enrollment to the end of treatment at 6 weeks.

Secondary Outcomes (2)

  • Therapy Attitude Inventory

    From enrollment to end of treatment at 6 weeks.

  • Developmentally Appropriate Discipline Inventory

    From enrollment to end of treatment at 6 weeks.

Study Arms (1)

DOCS Parenting Intervention

EXPERIMENTAL

HOT DOCS administered for caregivers of children 0-5 years; DOCS K-5 administered for caregivers of children in Kindergarten thru 5th grade; Professionals working with children birth-5th grade can enroll in either program

Behavioral: Helping our Toddlers, Developing our Children's SkillsBehavioral: Developing our Children's Skills K-5

Interventions

DOCS K-5 is a group delivered behavioral parent training intervention for caregivers and professionals of children in Kindergarten thru 5th Grade

DOCS Parenting Intervention

HOT DOCS is a group delivered behavioral parenting intervention for caregivers and professionals of children 0-5 years

DOCS Parenting Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • caregiver or professional caring for child ages 0-12 years, or
  • caregiver or professional caring for a child enrolled in kindergarten-5th grade.
  • Must speak English or Spanish.

You may not qualify if:

  • Language other than English or Spanish.
  • Caregiver/professional under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

Related Publications (5)

  • Rich, B. A., & M., E. S. (2001). Accuracy of assessment: The discriminative and predictive power of the Eyberg Child Behavior Inventory. Ambulatory Child Health, 7, 249-257.

    BACKGROUND
  • Silva, L. M., & Schalock, M. (2012). Autism parenting stress index: Initial psychometric evidence. Journal of Autism and Developmental Disorders, 42(4), 566-574. https://doi.org/10.1007/s10803-011-1274-1

    BACKGROUND
  • Boggs, S. R., Eyberg, S., & Reynolds, L. A. (1990). Concurrent validity of the Eyberg Child Behavior Inventory. Journal of Clinical Child Psychology, 19(1), 75-78. https://doi.org/10.1207/s15374424jccp1901_9

    BACKGROUND
  • Funderburk, B. W., Eyberg, S. M., Rich, B. A., & Behar, L. (2003). Further psychometric evaluation of the Eyberg and Behar rating scales for parents and teachers of preschoolers. Early Education and Development, 14(1), 67-82.

    BACKGROUND
  • Calzada EJ, Eyberg SM, Rich B, Querido JG. Parenting disruptive preschoolers: experiences of mothers and fathers. J Abnorm Child Psychol. 2004 Apr;32(2):203-13. doi: 10.1023/b:jacp.0000019771.43161.1c.

    PMID: 15164861BACKGROUND

MeSH Terms

Conditions

Problem BehaviorDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild BehaviorNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

April 1, 2026

Study Start

October 2, 2018

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

I do not have IRB approval to share IPD.

Locations