Back to resultsOpen Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
COPE parent training
Sponsored by
About this trial
This is an interventional treatment trial for ADHD
Eligibility Criteria
Inclusion Criteria:
- ADHD diagnosis
- Intelligence Quotient (IQ) greater than or equal to 70
- At least 1 parent/guardian who can attend zoom sessions
- Access to reliable internet connection for zoom meetings
Exclusion Criteria:
- Evidence of psychosis, suicidal behaviors, or autism level 2/3
Sites / Locations
- Center for Children and Families
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Community Parent Education Program (COPE) parent training program
Arm Description
Parents will enroll in an 8-week, group parenting program.
Outcomes
Primary Outcome Measures
Observations of parenting behaviors during parent-child interaction
Dyadic Parent Child Interaction code frequency counts for the categories of Negative Talk, Praise, and Commands
Impairment Rating Scale
Average score across domains with scores ranging from 0 (No problem) to 6 (Extreme problem)
Secondary Outcome Measures
Full Information
NCT ID
NCT04636216
First Posted
October 22, 2020
Last Updated
October 27, 2021
Sponsor
Florida International University
1. Study Identification
Unique Protocol Identification Number
NCT04636216
Brief Title
Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder (ADHD)
Official Title
Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder in Online Group Meetings
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Behavioral parent training is an evidence-based treatment for ADHD. The intervention can be implemented individually, or in groups. Currently, group-based parent training programs require considerable coordination, including ascertainment of a large physical space, the coordination of all families traveling to the same location at the same time, and the require for the provision of childcare. Innovations in online connectivity and ease of implementation of online support applications (e.g., Zoom) may reduce these barriers. However, it is necessary to investigate the feasibility and promise of the online approach to ensure it supports parents effectively.
Detailed Description
This study will utilize a pre-post, open trial design as the primary aim is to investigate feasibility. Approximately sixty parents will complete prepost ratings of parenting behaviors and measures of child functioning. They will also complete post treatment measures of satisfaction and open-ended questions about feasibility and suggestions for future iterations of the approach. Process measures will include data collection related to attendance and engagement in the activities. Risks include breach of confidentiality and a lack of effectiveness of the intervention for the child's presenting problems. Benefits include the parent receiving an effective intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open, single-group trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Community Parent Education Program (COPE) parent training program
Arm Type
Experimental
Arm Description
Parents will enroll in an 8-week, group parenting program.
Intervention Type
Behavioral
Intervention Name(s)
COPE parent training
Intervention Description
Weekly 1.5 hour parent training meetings for eight weeks
Primary Outcome Measure Information:
Title
Observations of parenting behaviors during parent-child interaction
Description
Dyadic Parent Child Interaction code frequency counts for the categories of Negative Talk, Praise, and Commands
Time Frame
8 weeks
Title
Impairment Rating Scale
Description
Average score across domains with scores ranging from 0 (No problem) to 6 (Extreme problem)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ADHD diagnosis
Intelligence Quotient (IQ) greater than or equal to 70
At least 1 parent/guardian who can attend zoom sessions
Access to reliable internet connection for zoom meetings
Exclusion Criteria:
Evidence of psychosis, suicidal behaviors, or autism level 2/3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A Fabiano, Ph.D.
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Children and Families
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder (ADHD)
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