The Impact of Mechanisms of Action in Unguided Digital Mental Health Interventions

University of Haifa

Status: Active, not recruiting

Conditions: DPT-TP; DPT-STD

Treatments: Behavioral: DPT-STD; Behavioral: DPT-TP

Study type: Interventional

Funder types: Other

Identifiers

NCT06514326

418/23

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

160 participants in 2 patient groups

DPT-STD

Active Comparator group

Description:

This is the standard intervention arm

Treatment:

Behavioral: DPT-STD

DPT-TP

Experimental group

Description:

This is the enhanced intervention arm

Treatment:

Behavioral: DPT-TP