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Task-Based Grounding Program

NCT04648553 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-11-08

No results posted yet for this study

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.

Conditions

  • Aggressive
  • Defiant Disorder, Oppositional
  • Attention Deficit Hyperactivity Disorder

Interventions

BEHAVIORAL

Task-Based Grounding

Three 50 minutes sessions with an interventionist that includes 6 non-punitive components of treatment common in Behavioral Parent Trainings: Education on behavior change, positive one-on-one time between parents and their children, differential attending to positive and negative behaviors, effective praise, giving effective instructions, and using a point and reward system to encourage prosocial behaviors. These components are distilled into 5 skill modules and paired with Task-Based Grounding, which involves a brief restriction of privileges and provides children with the opportunity to end the restriction by completing a prosocial task.

BEHAVIORAL

Connected Care (Enhanced Treatment as usual)

Two sessions with a facilitator. The facilitator does NOT provide any guidance to the parent on managing their child's behavior, but provides empathy and problem solving to help them find a resource that best fits their needs. It is particularly geared towards helping parents connect with Behavioral Parent Trainings to address the needs of children with oppositional, defiant, or aggressive behaviors.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • James T Craig, Ph.D. · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2021-10-01
Completion
2021-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04648553 on ClinicalTrials.gov