- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505381
Behavioral Parent Training to Address Early Childhood Disruptive Behavior Using the Helping Our Toddlers, Developing Our Children's Skills (HOT DOCS) Program and the Developing Our Children's Skills Kindergarten-5th Grade (DOCS K-5) Program (DOCS parenting)
HOT DOCS and DOCS K-5
Study Overview
Status
Conditions
Detailed Description
Challenging behaviors such as whining, temper tantrums, and non-compliance are very common during the toddler and preschool years, and if left unaddressed, will persist through early and middle childhood. Children with special needs are at even greater risk for behavioral problems. Caregivers may not understand why their children misbehave and may become frustrated in their attempts to discipline.
The HOT DOCS & DOCS K-5 programs offer caregivers a problem-solving approach to understand and resolve everyday behavior problems. These programs emphasize prevention strategies and positive behavior supports. Caregivers who have completed HOT DOCS and DOCS K-5 report gains in their parenting skills, reductions in parenting stress and child behavior problems, and satisfaction with the programs.
HOT DOCS and DOCS K-5 classes are available in both English and Spanish. HOT DOCS has been recognized as an outstanding community resource, and has received awards from Early Steps, the Early Childhood Council, and the Hispanic Heritage Committee.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33620
- Recruiting
- University of South Florida
-
Contact:
- Heather Agazzi, PhD
- Phone Number: 813-974-0606
- Email: hcurtis@usf.edu
-
Contact:
- Sarah Dickinson, PhD
- Phone Number: 813-974-5770
- Email: sdickinson@usf.edu
-
Principal Investigator:
- Heather Agazzi, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Language other than English or Spanish.
- Caregiver/professional under the age of 18.
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Experimental: DOCS Parenting Intervention
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
|
HOT DOCS is a group delivered behavioral parenting intervention for caregivers and professionals of children 0-5 years
DOCS K-5 is a group delivered behavioral parent training intervention for caregivers and professionals of children in Kindergarten thru 5th Grade
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eyberg Child Behavior Inventory
Time Frame: From enrollment to the end of treatment at 6 weeks.
|
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
Time Frame: From enrollment to the end of treatment at 6 weeks.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Developmentally Appropriate Discipline Inventory
Time Frame: From enrollment to end of treatment at 6 weeks.
|
The Developmentally Appropriate Discipline Inventory is administered at post-test to assess participant knowledge of developmentally appropriate discipline strategies as a result of participating in the DOCS intervention.
The DADI has 10 items covering discipline techniques taught in the intervention.
The DADI uses a 5-point Likert scale with responses ranging from strongly disagree (e.g., 1 = strongly disagree, etc.) to strongly agree (e.g., 5 = strongly agree.)
and overall scores range from 10-50 with higher scores = better outcome.
|
From enrollment to end of treatment at 6 weeks.
|
|
Therapy Attitude Inventory
Time Frame: From enrollment to end of treatment at 6 weeks.
|
The Therapy Attitude Inventory (TAI) is administered at post-test to assess participant satisfaction.
The TAI has 10 items covering discipline techniques taught in the course and caregiver confidence with using them, and strategies for teaching modeled through the course etc.
The TAI uses a 5-point Likert scale with responses ranging from no satisfaction or improvement (e.g., 1 = nothing, much worse than before, etc.) to high levels of satisfaction or improvement (e.g., 5 = greatly improved, very satisfied, etc.) and overall scores range from 10-50 with higher scores = better outcome.
The TAI has demonstrated excellent reliability, good test-retest reliability and acceptable internal consistency (αs = .91,
.85,
and .78,
respectively.
|
From enrollment to end of treatment at 6 weeks.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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
- 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
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00032638
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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