Randomized Controlled Trial of the Myndlift BPT App

ADHD Clinical Trial

Official title: Randomized Controlled Trial of the Myndlift BPT App

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Over the past several decades, much of the literature on attention-deficit/hyperactivity disorder (ADHD) and other disruptive behavior disorders (DBDs; i.e., conduct disorder/CD and oppositional defiant disorder/ODD) in children has focused on evaluating the effectiveness of different treatment approaches. While research has determined that pharmacological treatments can be considered well-established and evidence-based, they are not always sufficient - in that, a variety of individual differences may limit the effectiveness of drug treatment for any given individual - and can lead to a host of undesired side effects (Chacko et al., 2015). Additionally, parents are often resistant to medicating their children, particularly at younger ages, and prefer to engage in other treatment options, when possible (Charach et al., 2006). Research on psychosocial approaches has likewise determined that behavioral parent training (BPT) interventions are well-established and evidence-based, and over time, BPT has become one of the most well-studied and efficacious psychosocial interventions for families with children with ADHD (Chacko et al., 2015).

In light of the growing importance of readily available and accessible hybrid (online, self-directed with therapist support) BPT, our research team, in collaboration with Myndlift (a leading technology-based company that translates evidence-based non-pharmacological interventions into online delivery formats), proposes a study of hybrid BPT for parents of children with or at risk for ADHD. The specific aims of the study are: 1) to determine the feasibility and acceptability/satisfaction with the hybrid BPT and, 2) relative to a wait-list control condition, to determine the impact of the hybrid BPT on child (ADHD and related behavioral problems; impairment) and parent (parenting behavior, parental stress, parenting competence) outcomes.

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. ;

Related Conditions & MeSH terms

• ADHD
• Behavioral Disorder
• Problem Behavior

• NCT number: NCT05182424
• Study type: Interventional
• Source: New York University
• Contact: Anil Chacko, PhD
• Phone: 212-998-5749
• Email: Anil.chacko@nyu.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Completion date: June 30, 2022