Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder (ADHD)

ADHD Clinical Trial

Official title:

Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder in Online Group Meetings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636216
• Other study ID #: IRB-20-0484
• Status: Completed
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: October 2021
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• COPE parent training
Weekly 1.5 hour parent training meetings for eight weeks

Locations

Country	Name	City	State
United States	Center for Children and Families	Amherst	New York

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observations of parenting behaviors during parent-child interaction	Dyadic Parent Child Interaction code frequency counts for the categories of Negative Talk, Praise, and Commands	8 weeks
Primary	Impairment Rating Scale	Average score across domains with scores ranging from 0 (No problem) to 6 (Extreme problem)	8 weeks