Clinical trial NCT05674968: Managing Challenging Behaviors-ADHD
Official title: A Pilot Feasibility Randomized Control Trial of the Managing Challenging Behaviors in ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosocial Intervention
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 47
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 families will be enrolled in the study. The researchers will use block randomization to assign half to the treatment group and half to a wait-list control group. Participants will be blocked by gender and condition.
Primary purpose: TREATMENT

Brief 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 .


Eligibility criteria: Inclusion Criteria:

1. Children between ages 3-8 receiving services at the developmental pediatrics clinic at DH Lebanon referred by their physician for help with disruptive behaviors.
2. A diagnosis ADHD, ODD, Adjustment Disorder with Conduct, or Disruptive Behavior Disorder documented in the chart.
3. Family participating is capable of receiving in-person or telehealth care and treatment materials in English

Exclusion Criteria:

1. Primary concern that would indicate that behavioral parent training would not be the treatment of choice at the time of referral, including Autism Spectrum Disorder, previously untreated Post Traumatic Stress Disorder, OCD, or Reactive Attachment Disorder. The study clinician may also use clinical judgment that the intervention is inappropriate for a particular child's needs at any point during intervention.
2. Currently receiving outpatient therapy at the time of referral. The study will not exclude children on psychotropic medications, but will document medication status and changes to medication throughout treatment.
3. Severe history of physical or mental impairment (e.g., intellectual disability, global developmental delay). Child must be capable of verbal communication with a parent.
4. Children who are in foster care or are currently wards of the state.
5. Primary caregivers under 18 years of age.

Primary outcomes:
measure: Change in ADHD-5
timeFrame: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.
measure: Change in Eyberg Child Behavior Inventory
timeFrame: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.
measure: Change in Impairment Rating Scale
timeFrame: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.
measure: Treatment Acceptability as evidenced by The Treatment Evaluation Inventory-Short Form
timeFrame: Measured only at 14 weeks after baseline in the treatment group.
measure: Treatment acceptability as evidenced by Parent Consumer Satisfaction Questionnaire
timeFrame: Measured only at 14 weeks after baseline in the treatment group.
measure: Changes in Clinician Global Impairment
timeFrame: Measured at baseline and 14 weeks after baseline. Treatment group only.
Secondary outcomes:
measure: Changes in the Barriers to Children's Mental Health Survey
timeFrame: Measured at baseline and 14 weeks after baseline.
measure: Changes in the Parenting Scale (PS; Rhodes & Leary, 2007).
timeFrame: Measured at baseline and 14 weeks after baseline.
measure: Changes in Family Empowerment Scale
timeFrame: Measured at baseline and 14 weeks after baseline.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: