DPT-STDNCT06514326
The Impact of Mechanisms of Action in Unguided Digital Mental Health Interventions
A study testing DPT-TP and DPT-STD in people with DPT-STD and DPT-TP, run by University of Haifa at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- DPT-TP and DPT-STD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Sep 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Mechanisms of Action on Adherence and Outcomes in Unguided Digital Mental Health Interventions: A Randomized Controlled Trial
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.
- Being tested
- DPT-TP, DPT-STD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPT-TPBehavioural
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:
- 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.
- 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.
- 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.
DPT-STDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DPT-STD | Active comparator | This is the standard intervention arm Receives: Behavioral: DPT-STD |
| DPT-TP | Experimental | This is the enhanced intervention arm Receives: Behavioral: DPT-TP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to 6 months follow-up
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: From baseline to 6 months follow-up
Specific Parenting Practices (SPP)
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).
Measured: 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).
Measured: 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.
Measured: From baseline to 10 weeks time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start15 Sep 2024
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DPT-STDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Baumel, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514326
- Sponsor's protocol ID
- 418/23
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40397492
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mechanisms of Action on Adherence and Outcomes in Unguided Digital Mental Health Interventions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06514326
- Acronym / sponsor ID
- 418/23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPT-STD | Active comparator | Behavioral: DPT-STDThis is the standard intervention arm |
| DPT-TP | Experimental | Behavioral: DPT-TPThis is the enhanced intervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPT-TPThis 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. | Behavioural | DPT-TP |
| DPT-STDThis 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. | Behavioural | DPT-STD |
Primary outcome
Eyberg Child Behavior Inventory (ECBI)
Time frame: 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).
7 secondary outcomes
The Parenting Scale (PS)
Time frame: From baseline to 6 months follow-up
Alabama Parenting Questionnaire (APQ)
Time frame: From baseline to 6 months follow-up
The Parenting Tasks Checklist (PTC)
Time frame: From baseline to 6 months follow-up
Parental Self Efficacy (Me as a Parent [MaaP])
Time frame: From baseline to 6 months follow-up
Specific Parenting Practices (SPP)
Time frame: From baseline to 6 months follow-up
Behavior and Feelings Survey (BFS)
Time frame: From baseline to 6 months follow-up
Program Completion
Time frame: From baseline to 10 weeks time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 40397492Baumel 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPT-TP and DPT-STD in people with DPT-STD and DPT-TP, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyberg Child Behavior Inventory (ECBI) (time frame: From baseline to 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.