Randomized Controlled Trial of the Myndlift BPT App

NCT05182424 | Unknown

• 1 other identifier: IRB-FY2022-5839
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ADHD; Behavioral Disorder; Telehealth; Behavioral Parent Training (BPT); Parents; Parent; Parent Training; Children; Disruptive Behaviors

Outcome Measures

Primary Outcomes (6)

• Change in ADHD Rating Scale-5: Home Version (ADHD-RS5) from Baseline to 12-week Follow up

  The ADHD-RS5 Home Version is a rating scale based on the diagnostic criteria for ADHD as described in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The ADHD-RS5 consists of two symptom subscales: Inattention (9 items) and Hyperactivity-Impulsivity (9 items), as well as a Total Scale (18 items). In addition, the ADHD Rating Scale-5 assesses six domains of impairment that are common among children with ADHD: relationships with significant others (family members for the home version and teachers for the school version), peer relationships, academic functioning, behavioral functioning, homework performance, and self-esteem. When using the ADHD Rating Scale-5, respondents complete each set of impairment items twice, first after rating the inattention symptom items and again after rating the hyperactivity-impulsivity items.

  Baseline, 12 Week Follow Up

• Change in Disruptive Behavior Disorders (DBD) Rating Scale from Baseline to 12-week Follow up

  The DBD scale is a 45-item measure that asks parents to rate symptoms of ADHD, ODD, and CD on a 4-point Likert scale (i.e., "not at all", "just a little", "pretty much", or "very much"), with higher scores indicating more problems. For this study, the average scores for the DSM ODD and CD will be used. Support for the scale's reliability and validity have been reported in past samples, with acceptable levels of internal consistency (.82) and concurrent correlations with other measures used for diagnosis of ADHD and ODD being reported (Pelham et al., 2005).

  Baseline, 12 Week Follow Up

• Change in Impairment Rating Scale - Parent/Teacher Version (IRS) from Baseline to 12-week Follow up

  The IRS is a multidimensional measure that assesses functioning across domains. Specifically, the IRS qualifies and quantifies impairment present in a child's life, both in school and non-school settings. The scale has parent and teacher versions that ask about the degree to which the child has problems that warrant treatment, intervention, or special services in specific areas of functioning. For children ages 4 through 12, the IRS has shown good psychometric properties and has empirically derived cutoff points. The IRS asks the informant to respond using a 7-point scale that ranges from "No problem; definitely does not need treatment or special services" to "Extreme problem; definitely needs treatment or special services." The IRS exhibits concurrent, discriminant, and convergent validity, and acceptable levels of temporal stability.

  Baseline, 12 Week Follow Up

• Change in Parenting Stress Index - Short Form (PSI-SF) from Baseline to 12-week Follow up

  The PSI-SF measures the level of stress in the parent-child relationship and is appropriate for use with children aged 1 month to 12 years. It was derived from the longer Parenting Stress Index and consists of 36 statements, each rated on a 1 to 5 scale (1=strongly disagree, 5=strongly agree), which produces a Total Stress score. The items also cluster to produce three subscale scores (Parental Distress, Difficult Child, and Parent-child Dysfunctional Interaction) each derived from ratings of 12 items.

  Baseline, 12 Week Follow Up

• Change in The Parenting Scale (PS) from Baseline to 12-week Follow up

  The PS is a 30-item parent self-report measure of dysfunctional parenting in discipline situations. For each item, parents are asked to rate on a seven-point Likert scale about their likelihood of using a specific discipline strategy. It yields a total score based on three factors: Laxness (permissive discipline), Overreactivity (authoritarian discipline, displays of anger, meanness, and irritability), and Verbosity MYNDLIFT BPT SURVEY PACKET 8 (overly long reprimands or reliance on talking). The total score has demonstrated adequate internal consistency (α = .84) and good test-retest reliability (r = .84).

  Baseline, 12 Week Follow Up

• Change in Parenting Sense of Competence (PSOC) from Baseline to 12-week Follow up

  The Parenting Sense of Competence (PSOC) scale is a commonly used measure of parental self-efficacy. The PSOC is a 17-item questionnaire that measures overall parenting sense of competence and includes two sub-scales measuring parental satisfaction and parental self-efficacy. The Efficacy factor examines the parents' competence, capability levels, and problem-solving abilities in their parental role; the Satisfaction factor examines the parents' anxiety, motivation, and frustration.

  Baseline, 12 Week Follow Up

Study Arms (2)

Myndlift BPT Immediate Treatment

EXPERIMENTAL

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.

Behavioral: Myndlift BPT App & As-Needed Therapist Support

Waitlist Control Group

OTHER

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.

Behavioral: Myndlift BPT App & As-Needed Therapist Support

Interventions

Myndlift BPT App & As-Needed Therapist Support BEHAVIORAL

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).

Myndlift BPT Immediate Treatment; Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the child must be between the ages of 3-11 at the time of baseline/pretreatment data collection;
• the child must have an elevated score based on parent-report on the Inattention and/or Hyperactivity/Impulsivity Symptom Index of the ADHD Rating Scale- 5 (Dupual et al., 2016)
• the parent/caregiver must be a fluent English speaker;
• the parent/caregiver must be the legal guardians of and have full-time child care responsibilities for their child (parents/caregiver with limited contact with their child will not have the opportunity to sufficiently practice the BPT skills),
• the parent/caregiver must have reliable and stable mobile internet access,
• the parent/caregiver must use an Apple iOS operating system (Myndlift BPT is only available in iOS 9 or above) the parent/caregiver and their child must reside in the United States.

You may not qualify if:

• the child or parent/caregiver presents with emergency psychiatric needs that require services beyond those that can be managed within this intervention format (e.g., hospitalization, specialized placement outside the home); In this case, an active intervention by research staff to secure what is needed will be made;
• if the child has an elevated score for Autism Spectrum Disorder on the Developmental Behavior Checklist-Autism Screening Algorithm (youth with ASD often require considerably more intervention; and,
• if the parent/caregiver is currently enrolled or has recently enrolled in any type of BPT program (i.e., past two years).

Sponsors & Collaborators

• New York University: lead
• Myndlift Ltd.: collaborator

Study Sites (1)

New York University

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Mental Disorders; Problem Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Anil Chacko, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anil Chacko, PhD

CONTACT

212-998-5749; Anil.chacko@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: January 1, 2022
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: January 10, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)