Clinical trial NCT06514326: The Impact of Mechanisms of Action in Unguided Digital Mental Health Interventions
Official title: The Impact of Mechanisms of Action on Adherence and Outcomes in Unguided Digital Mental Health Interventions: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: DPT-STD
DPT-TP
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Parents having a child between the ages of 3 and 7
* The parents report high levels of behavior problems demonstrated by their child based on the ECBI Intensity subscale (X ≥ 132)
* The parents have access to a smartphone device with an Internet connection.

Exclusion Criteria:

* The child is taking medication for behavioral or emotional problems
* The child is in regular contact with a professional for behavioral or emotional problems
* their child has been diagnosed with an intellectual disability or developmental delay
* The parents are currently accessing parenting support elsewhere

Primary outcomes:
measure: Eyberg Child Behavior Inventory (ECBI)
timeFrame: From baseline to 6 months follow-up
Secondary outcomes:
measure: The Parenting Scale (PS)
timeFrame: From baseline to 6 months follow-up
measure: Alabama Parenting Questionnaire (APQ)
timeFrame: From baseline to 6 months follow-up
measure: The Parenting Tasks Checklist (PTC)
timeFrame: From baseline to 6 months follow-up
measure: Parental Self Efficacy (Me as a Parent [MaaP])
timeFrame: From baseline to 6 months follow-up
measure: Specific Parenting Practices (SPP)
timeFrame: From baseline to 6 months follow-up
measure: Behavior and Feelings Survey (BFS)
timeFrame: From baseline to 6 months follow-up
measure: Program Completion
timeFrame: From baseline to 10 weeks time
Other outcomes:
measure: Minutes of use-Program usage
timeFrame: From baseline to 10 weeks time
measure: Number of logins-Program usage
timeFrame: From baseline to 10 weeks time
measure: Unique days-Program usage
timeFrame: From baseline to 10 weeks time
measure: Phases completed
timeFrame: From baseline to 10 weeks time
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
References: