Managing Challenging Behaviors in ADHD for Psychosocial Intervention

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Psychosocial InterventionManaging Challenging Behaviors in ADHD; Psychosocial program - Behavioral
Eligibility
3 - 8
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to test whether short, time-limited parent education programs designed to help children diagnosed with ADHD and disruptive behaviors can be helpful to families that may not be able to participate in "traditional" forms of mental health care. In short, the researchers want to know if a new program is acceptable and helpful for parents or caregivers looking for ways to help their child with problem behaviors related to ADHD. The researchers hope to enroll 60 families in the study. Half will be randomly assigned to participate in a 7-session therapy program and the other half will be asked to wait 24 weeks before being offered the treatment. Parents in the study will fill out questionnaires at week 1, week 14, and week 24. The researchers' goal is to answer 2 specific questions. 1) Is this protocol acceptable to families and do they choose to participate and 2) Are the researchers able to accurately measure our outcomes of interest, specifically, changes in children's behavior problems, changes in parenting practices, and parents' perceptions of mental health care. This study is focused on whether the intervention and study methods are acceptable. The researchers will compare the two groups to see if there are differences, but it would require a larger group of children and parents before the researchers can determine whether these differences are meaningful .

Treatment Effectiveness

Study Objectives

6 Primary · 3 Secondary · Reporting Duration: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.

Week 14
Changes in Family Empowerment Scale
Changes in the Barriers to Children's Mental Health Survey
Changes in the Parenting Scale (PS; Rhodes & Leary, 2007).
Week 14
Changes in Clinician Global Impairment
Week 24
Change in ADHD-5
Change in Eyberg Child Behavior Inventory
Change in Impairment Rating Scale
Week 14
Treatment Acceptability as evidenced by The Treatment Evaluation Inventory-Short Form
Treatment acceptability as evidenced by Parent Consumer Satisfaction Questionnaire

Trial Safety

Trial Design

2 Treatment Groups

Wait List
1 of 2
Managing Challenging Behaviors in ADHD
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Managing Challenging Behaviors in ADHD · No Placebo Group · N/A

Managing Challenging Behaviors in ADHD
Behavioral
Experimental Group · 1 Intervention: Managing Challenging Behaviors in ADHD; Psychosocial program · Intervention Types: Behavioral
Wait ListNoIntervention Group · 1 Intervention: Wait List · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
489 Previous Clinical Trials
2,534,030 Total Patients Enrolled

Eligibility Criteria

Age 3 - 8 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Children aged 3 to 8, who are referred by their physician for assistance with disruptive behavior from the developmental pediatrics clinic at DH Lebanon, can receive services.
You have been clinically diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Adjustment Disorder with Conduct, or Disruptive Behavior Disorders.
Your family is able to obtain both in-person and telehealth care, along with materials presented in English.