Task-Based Grounding Program

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: A Pilot Randomized Control Trial of the Task-Based Grounding Program

Status Completed

Clinical Trial Summary

The purpose of this study is to improve the availability of brief interventions to help children with defiant, aggressive and disruptive behaviors by creating a brief scalable intervention for parents delivered via telehealth. As phase 1 study, we are conducting a 2-arm pilot feasibility RCT in order the intervention, measures, and procedures to be used in a larger efficacy trial. The first arm will include a 3-session behavioral therapy treatment we call Task-Based Grounding and the second arm will be an enhanced treatment as usual comparison group.

Clinical Trial Description

The investigators have developed a 3-session psychosocial intervention for parents of children between 9-14 with disruptive behaviors. The intervention uses telehealth visits along with written and online resources to teach them parent management skills. To evaluate the acceptability of this intervention and the feasibility of our methods, the investigators will recruit 20 parent-child dyads to participate in this study. This is a mixed methods pilot feasibility RCT design. The investigators designed this study to test the acceptability of the intervention to parents and test the feasibility of our recruitment, retention, measurement, and delivery mechanisms for both the experimental and comparison conditions. The investigators will use a block randomization method to separate parent-child dyads into either treatment or comparison groups. The treatment condition involves 3 telehealth visits and a set of parenting resources. The enhanced treatment as usual condition will involve contact with a "care navigator" that will assess behavior problems in the child and help the parents find an appropriate referral to care in their community. Both groups will be followed for 10 weeks, provide outcome data, and participate in semi-structured qualitative interviews to accept acceptability. ;

Related Conditions & MeSH terms

• Aggressive
• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Defiant Disorder, Oppositional
• Disease

• NCT number: NCT04648553
• Study type: Interventional
• Source: Dartmouth-Hitchcock Medical Center
• Status: Completed
• Phase: Phase 1
• Start date: December 3, 2020
• Completion date: October 1, 2021