Managing Challenging Behaviors-ADHD

NCT ID: NCT05674968

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2024-06-01

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 .

Conditions

Psychosocial Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Managing Challenging Behaviors in ADHD

This is a 7-session behavioral parent training delivered to children ages 3-7 referred to the study after an initial ADHD diagnosis or when challenging behaviors are identified by their medical provider.

Group Type: EXPERIMENTAL

Managing Challenging Behaviors in ADHD; Psychosocial program

Intervention Type: BEHAVIORAL

MCB-ADHD is a brief Behavioral Parent Training (BPT) program delivered to caregivers and children together. THe researchers have specially designed this program to be flexible so that it can be delivered over telehealth and/or in-person. All sessions are guided by web-based tool to provide parent support materials and direct the work to be completed in session. MCB-ADHD combines brief BPT skills modules adapted from an established evidence-based BPT called Helping the Noncompliant Child (HNC; McMahon \& Forehand, 2003) with high quality psychoeducation and advocacy training that were developed by the investigators specifically for use in this project. Families receive 4 sessions adapted from HNC focused on behavior management and 2 sessions focused on education and empowerment.

Wait List

Families assigned to the wait list will complete measures at baseline, 14 weeks, and 24 weeks. After 24 weeks they will be offered the experimental treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Managing Challenging Behaviors in ADHD; Psychosocial program

MCB-ADHD is a brief Behavioral Parent Training (BPT) program delivered to caregivers and children together. THe researchers have specially designed this program to be flexible so that it can be delivered over telehealth and/or in-person. All sessions are guided by web-based tool to provide parent support materials and direct the work to be completed in session. MCB-ADHD combines brief BPT skills modules adapted from an established evidence-based BPT called Helping the Noncompliant Child (HNC; McMahon \& Forehand, 2003) with high quality psychoeducation and advocacy training that were developed by the investigators specifically for use in this project. Families receive 4 sessions adapted from HNC focused on behavior management and 2 sessions focused on education and empowerment.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James T. Craig

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

STUDY02001611

Identifier Type: -

Identifier Source: org_study_id