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

NCT ID: NCT06514326

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2027-10-31

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.

Conditions

DPT-STD; DPT-TP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DPT-STD

This is the standard intervention arm

Group Type: ACTIVE_COMPARATOR

DPT-STD

Intervention Type: BEHAVIORAL

This intervention is similar in its features to other programs that deliver DPT, and is suitable for use on computers or on mobile devices. An icon is positioned on the mobile device home screen in order to enable quick access to the program. The DPT-STD comprises seven 10- to 25-minute modules, each corresponding to one of the themes mentioned above. Each module's content includes videos and texts guiding the parent through the training process, and interactive features, such as multiple-choice questions with direct feedback. Additional features embedded within the platform include downloadable materials and a "questions and answers" section that contains frequently asked questions.

DPT-TP

This is the enhanced intervention arm

Group Type: EXPERIMENTAL

DPT-TP

Intervention Type: BEHAVIORAL

This intervention includes all the ingredients of DPT-STD, but with additional features that correspond to the conceptual model of therapeutic persuasiveness. Each theme in the program comprises a learning phase followed by a 1-2 week focusing phase.

Accordingly, the program utilizes the following features:

1. Call to action: Parents receive timely triggers via text messages that are related to the specific goals and therapeutic activities of the modules they have completed.

2. Monitoring and ongoing feedback of user state: Specific practices currently taught are documented within the system through a brief daily report, on which parents receive feedback.

3. Adaptation to user state: Parents' reports on their activities are used to acknowledge their success and to suggest additional actions based on the specific goals reported by parents. Effort related to desired therapeutic activities is adapted based on graded tasks.

Interventions

DPT-TP

This intervention includes all the ingredients of DPT-STD, but with additional features that correspond to the conceptual model of therapeutic persuasiveness. Each theme in the program comprises a learning phase followed by a 1-2 week focusing phase.

Accordingly, the program utilizes the following features:

1. Call to action: Parents receive timely triggers via text messages that are related to the specific goals and therapeutic activities of the modules they have completed.

2. Monitoring and ongoing feedback of user state: Specific practices currently taught are documented within the system through a brief daily report, on which parents receive feedback.

3. Adaptation to user state: Parents' reports on their activities are used to acknowledge their success and to suggest additional actions based on the specific goals reported by parents. Effort related to desired therapeutic activities is adapted based on graded tasks.

Intervention Type: BEHAVIORAL

DPT-STD

This intervention is similar in its features to other programs that deliver DPT, and is suitable for use on computers or on mobile devices. An icon is positioned on the mobile device home screen in order to enable quick access to the program. The DPT-STD comprises seven 10- to 25-minute modules, each corresponding to one of the themes mentioned above. Each module's content includes videos and texts guiding the parent through the training process, and interactive features, such as multiple-choice questions with direct feedback. Additional features embedded within the platform include downloadable materials and a "questions and answers" section that contains frequently asked questions.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Amit Baumel

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Haifa

Haifa, , Israel

Countries

Israel

References

Baumel A, Aderka IM. The Impact of Mechanisms of Action on Adherence and Outcomes in Self-Guided Digital Mental Health Interventions: Protocol for a Randomized Controlled Trial With Mediation Analysis. JMIR Res Protoc. 2025 May 21;14:e71238. doi: 10.2196/71238.

Reference Type: DERIVED

PMID: 40397492 (View on PubMed)

Other Identifiers

418/23

Identifier Type: -

Identifier Source: org_study_id