Randomized Controlled Trial of the Myndlift BPT App

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.

Conditions

• ADHD
• Behavioral Disorder

Interventions

BEHAVIORAL

Myndlift BPT App & As-Needed Therapist Support

BPT is based on social learning and operant conditioning principles in which parents are instructed to utilize methods to facilitate positive behaviors in their child and reduce challenging behaviors. Myndlift BPT translates established content and processes into a digital format to be delivered through a mobile app. Myndlift content consists of 10 components, designed to be completed in a self-directed manner by parents, over the course of approximately 10 weeks (total weeks depends upon parent's pace through the program). In this project, trained and supervised doctoral- and masters-level students will serve as study therapists and meet with parents via a secured, password-protected Zoom platform to introduce parents to the Myndlift BPT (first session before start of the BPT), to support and problem solve BPT skills acquisition (during the Myndlift BPT), and at the end of the Myndlift BPT (to review the intervention content and consider the maintenance of skills).

Sponsors & Collaborators

• Myndlift Ltd.

  collaborator UNKNOWN

• New York University

  lead OTHER

Principal Investigators

• Anil Chacko, PhD · New York University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2022-03-31

Completion

2022-06-30

Countries

• United States

Study Locations