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Waitlist Control Group for Attention Deficit Hyperactivity Disorder (ADHD)

N/A
Waitlist Available
Led By Anil Chacko, PhD
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 week follow up
Awards & highlights

Study Summary

We propose addressing these aims by conducting a randomized controlled trial (RCT) that will evaluate the hybrid BPT (Myndlift BPT) compared to a wait-list control group. All participants will receive the Myndlift BPT at either the initial point of randomization or following the wait-list time period. The Myndlift BPT consists of 10, self-directed app-based BPT modules accessible through an online mobile application with each module requiring up to 30 minutes of parent's time. Therapist contact ("parent-therapist consults") will be based on parent need. We anticipate approximately six standard 20-minute therapist contacts during the Myndlift BPT (one prior to the start of the app-based BPT modules, four parent-therapist consults during the app-based BPT modules, and one final parent-therapist consult at the end of app-based BPT modules). Additional parent-therapist consults will be based on parents' needs. In addition, therapists will monitor parent progress and challenges with the app-based BPT modules using a web-based therapist portal. The therapist may initiate additional parent-therapist consults if s/he deems it necessary based on client progress, and contacts can be longer than 20 minutes if needed. All consults are completed through Zoom telehealth platform. Given the self-directed nature of the Myndlift BPT (parents decide how frequently they access the app-based modules of BPT and practice the skills), parent involvement in the intervention will vary slightly in duration. However, based on the literature and routine practice, we anticipate parents completing one module/week in the app-based parent feature for a total of 10 weeks with an additional therapist supported session at the start of the intervention and one at the end of the intervention for a total of 12 weeks of involvement in the Myndlift BPT. The research assessment (see details below) will occur at baseline and at the end of Myndlift BPT. Given that the assessments are linked to participant progress in the Myndlift BPT, participant involvement in the study will also slightly vary, but we anticipate that most parents will complete the assessment during a standard 12-week Myndlift BPT schedule.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Behavioral Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 week follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 week follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ADHD Rating Scale-5: Home Version (ADHD-RS5) from Baseline to 12-week Follow up
Change in Disruptive Behavior Disorders (DBD) Rating Scale from Baseline to 12-week Follow up
Change in Impairment Rating Scale - Parent/Teacher Version (IRS) from Baseline to 12-week Follow up
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Waitlist Control GroupExperimental Treatment1 Intervention
Following completion of consent and baseline assessment, parent participants randomly assigned to the waitlist condition will be requested to wait for a period of 12 weeks before accessing the program, modules, and receiving therapist support. They will be required to answer the time 2 (at 12 weeks following completion of the baseline assessment) assessment prior to starting the process. The time 2 assessment for the waitlist condition is identical to the post-treatment assessment for participants in the Myndlift BPT group except that questions related to experience with Myndlift BPT will not be included.
Group II: Myndlift BPT Immediate TreatmentExperimental Treatment1 Intervention
After the completion of consent, a battery of baseline assessments will be completed by the parent. Children will not be involved in the study assessment or interventions-only parents/caregivers. Parent(s) will be emailed baseline and post-treatment assessment surveys through Qualtrics to complete. Following completion of baseline assessment, study staff will meet with the parent via Zoom to review any questions with the consent and review and discuss questions/issues with the baseline assessment. Following completion of the post-treatment assessment, study staff will meet with the parent via Zoom to review and discuss questions/issues with the post-treatment assessment. Following this review, the post-treatment interview will be completed. Having study staff present has been found useful by parents should they have any questions or concerns about items on surveys.

Find a Location

Who is running the clinical trial?

Myndlift Ltd.UNKNOWN
1 Previous Clinical Trials
70 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
70 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
New York UniversityLead Sponsor
226 Previous Clinical Trials
314,195 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
186 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Anil Chacko, PhDPrincipal InvestigatorNew York University
3 Previous Clinical Trials
224 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
84 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

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~18 spots leftby Apr 2025