The Impact of Mechanisms of Action in Unguided Digital Mental Health Interventions
NCT Number: NCT06514326
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: DPT-STD|DPT-TP
Interventions: BEHAVIORAL: DPT-TP|BEHAVIORAL: DPT-STD
Sponsor: University of Haifa
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-10

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 200 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.

Primary Outcome Measures: Eyberg Child Behavior Inventory (ECBI), Child behavior problems will be assessed using the Intensity subscale of the 36-item ECBI. For each item, caregivers rate the intensity of the behavior (1 = never to 7 = always)., From baseline to 6 months follow-up
Secondary Outcome Measures: The Parenting Scale (PS), Parental disciplinary behaviors in response to their child's misbehaviors will be assessed using two PS subscale scores, Over-reactivity (11 items) and Laxness (10 items), which reflect effective discipline and discipline mistakes on either end, using a 7-point Likert scale., From baseline to 6 months follow-up|Alabama Parenting Questionnaire (APQ), One dimension of parenting practices will be assessed using the APQ Positive Parenting Practices subscale (6 items). Parents will be asked to rate each item on a scale of 1 (never) to 5 (always) according to how often it typically occurs in their home., From baseline to 6 months follow-up|The Parenting Tasks Checklist (PTC), Task-specific self-efficacy will be assessed using 6 items taken from the Behavioural Self-Efficacy PTC subscale. Item responses are given on a scale of 0 (Certain I can't do it) to 100 (Certain I can do it)., From baseline to 6 months follow-up|Parental Self Efficacy (Me as a Parent [MaaP]), Overall self-efficacy will be assessed using the 4-item Self-Efficacy subscale of MaaP. Sample items include "I have confidence in myself as a parent" and "My parenting skills are effective." Each item is rated on a Likert scale (1 = strongly disagree; 5 = strongly agree)., From baseline to 6 months follow-up|Behavior and Feelings Survey (BFS), The BFS-Internalizing Problems Caregiver version will be used to capture parents report on their childs emotional problems (e.g. anxiety and sadness). It is based on 6 items that are rated on a scale from 0 (not a problem) to 4 (a very big problem)., From baseline to 6 months follow-up|Program Completion, Program completion will be measured based on the percentage of learning modules completed by parents within their respected intervention Arm., From baseline to 10 weeks time
Other Outcome Measures: Minutes of use-Program usage, Minutes of use refers to the number of minutes users were logged into the program, From baseline to 10 weeks time|Number of logins-Program usage, number of unique logins refers to the number of times the user logged into the program, From baseline to 10 weeks time|Unique days-Program usage, The number of unique days in which the user logged in will be counted, From baseline to 10 weeks time|Phases completed, The exact learning modules completed by the parents will be documented, From baseline to 10 weeks time