CompletedNot Applicable

Managing Challenging Behaviors-ADHD

United States47 participantsStarted 2022-10-10

Plain-language 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 .

Who can participate

Age range3 Years – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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.
✕. 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.
✕. Severe history of physical or mental impairment (e.g., intellectual disability, global developmental delay). Child must be capable of verbal communication with a parent.

What they're measuring

Change in ADHD-5

Timeframe: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.

Change in Eyberg Child Behavior Inventory

Timeframe: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.

Change in Impairment Rating Scale

Timeframe: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.

Treatment Acceptability as evidenced by The Treatment Evaluation Inventory-Short Form

Timeframe: Measured only at 14 weeks after baseline in the treatment group.

Treatment acceptability as evidenced by Parent Consumer Satisfaction Questionnaire

Timeframe: Measured only at 14 weeks after baseline in the treatment group.

Changes in Clinician Global Impairment

Timeframe: Measured at baseline and 14 weeks after baseline. Treatment group only.

Trial details

NCT IDNCT05674968

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-01

View on ClinicalTrials.gov More Psychosocial Intervention trials

Plain-language summary

Who can participate

Age range3 Years – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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.
✕. 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.
✕. Severe history of physical or mental impairment (e.g., intellectual disability, global developmental delay). Child must be capable of verbal communication with a parent.

What they're measuring

Change in ADHD-5

Timeframe: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.

Change in Eyberg Child Behavior Inventory

Timeframe: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.

Change in Impairment Rating Scale

Timeframe: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.

Treatment Acceptability as evidenced by The Treatment Evaluation Inventory-Short Form

Timeframe: Measured only at 14 weeks after baseline in the treatment group.

Treatment acceptability as evidenced by Parent Consumer Satisfaction Questionnaire

Timeframe: Measured only at 14 weeks after baseline in the treatment group.

Changes in Clinician Global Impairment

Timeframe: Measured at baseline and 14 weeks after baseline. Treatment group only.