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

Not Applicable

Active, not recruiting

• Conditions: DPT-STD; DPT-TP
• Interventions: Behavioral: DPT-STD; Behavioral: DPT-TP

• Registration Number: NCT06514326
• Lead Sponsor: University of Haifa

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-23
• Study Start: 2024-09-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Primary Completion: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPT-STD	DPT-STD	This is the standard intervention arm
DPT-TP	DPT-TP	This is the enhanced intervention arm

Primary Outcome Measures

Name	Time	Method
Eyberg Child Behavior Inventory (ECBI)	From baseline to 6 months follow-up	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).

Secondary Outcome Measures

Name	Time	Method
The Parenting Scale (PS)	From baseline to 6 months follow-up	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.
Alabama Parenting Questionnaire (APQ)	From baseline to 6 months follow-up	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.
The Parenting Tasks Checklist (PTC)	From baseline to 6 months follow-up	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).
Parental Self Efficacy (Me as a Parent [MaaP])	From baseline to 6 months follow-up	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).
Specific Parenting Practices (SPP)	From baseline to 6 months follow-up	Specific Parenting Practices will be assessed using 12 items that ask about the skills parents acquire directly during the intervention. For example, a sample item targeting the practice of 'recognizing positive behaviors in your child' asks: 'To what extent were you able to express open appreciation and reinforce your child for a specific positive behavior demonstrated?' Parents will be asked to rate how often they demonstrated the expected skill in the past two weeks on a Likert scale (1 = Never; 7 = Always).
Behavior and Feelings Survey (BFS)	From baseline to 6 months follow-up	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).
Program Completion	From baseline to 10 weeks time	Program completion will be measured based on the percentage of learning modules completed by parents within their respected intervention Arm.

Trial Locations

Locations (1)

University of Haifa; 🇮🇱 Haifa, Israel