Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514326
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
The Impact of Mechanisms of Action in Unguided Digital Mental Health Interventions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Mechanisms of Action on Adherence and Outcomes in Unguided Digital Mental Health Interventions a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized controlled trial RCT will compare two interventions that utilize the same evidence-based components of established digital parent training programs DPTs aimed at treating child behavior problems but that differ in terms of the quality of therapeutic persuasiveness TP quality standard DPT-STD enhanced TP DPT-TP The investigators will recruit parents from 160 families with 3-7-year-old children with behavior problems who will be randomized into one of the two intervention arms The investigators will measure child behavior problems and related parenting variables before during and after the intervention DPT usage will be passively collected
The investigators hypothesize that compared to DPT-STD parents allocated to the DPT-TP arm will have significantly better module completion rates adherence to the program and report better outcomes - measured by improvements in child behavior problems and related parenting variables The investigators also hypothesize that changes in reported outcomes will be mediated by module completion rates Therefore comparing two active interventions that only differ in terms of their TP quality will enable to examine the causal link between this conceptual mechanism of action and beneficial outcomes
The investigators hypothesize that compared to DPT-STD parents allocated to the DPT-TP arm will have significantly better module completion rates adherence to the program and report better outcomes - measured by improvements in child behavior problems and related parenting variables The investigators also hypothesize that changes in reported outcomes will be mediated by module completion rates Therefore comparing two active interventions that only differ in terms of their TP quality will enable to examine the causal link between this conceptual mechanism of action and beneficial outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None