Child Behavior ProblemNCT05344885
A Pilot Trial Examining Digital Parent Training Programs
A study testing DPT-Standard and DPT-Enhanced in people with Child Behavior Problem and Parenting, run by University of Haifa at 1 site in Israel.
Trial summary
The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Child Behavior Problem, Parenting, Engagement, Patient
- What is being tested?
- DPT-Standard and DPT-Enhanced
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Apr 2022to 14 Nov 2022
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents report they have a child between the ages of 3 and 7, who:
- Has externalized behavior problems based on A) Parents report at least 1 of the two first criteria of behavior problems to be above 4 (the middle point) \& the average of all items ≥ 4, on a screening scale that consists of 9 items (on a Likert scale between 1 and 7) that is based on DSM-V symptoms for ODD.
- Parents report ECBI Problems to be above 14 OR Intensity to be above 130.
- Parents have access to computer at home with an Internet connection and a smartphone with a mobile data plan.
- Parents can read and understand Hebrew.
Who cannot join
- Parents report that the relevant child has been diagnosed with developmental delay, intellectual disability and/or autism spectrum disorder.
- Parent and/or child are already receiving therapeutic intervention (for the child) in other setting.
- The relevant child is treated with psychiatric medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impact of Intervention Design in Digital Parent Training for Child's Disruptive Behaviors: A Pilot Randomized Trial
The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. Parents will be enrolled into one of two digital parent training intervention arms, dedifferentiated by their level of correspondence with the related deign mechanism.
Read the detailed description
The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. The design mechanism manipulated in this pilot relates to the extent to which program design promotes a positive behavior change. To achieve these goal two unguided digital parent training interventions, differentiated by their level of design (DPT-Standard vs. DPT-Enhanced), will be tested. This pilot aims to recruit 40-60 parents who report behavior problems in their children who will randomly receive one of the two interventions for 10 weeks.
The impact of DPT-E on user engagement and reported child behavior problems will be assessed based on comparison with DPT-Standard. Parental behaviors and sense of competence will be collected to assess the impact of intervention design on these mechanisms of change. In addition, the role of parents' motivation, and their ability to invest effort in making changes during the intervention will be assessed, to examine whether these variables moderate the impact of intervention's design on the aforementioned relationships. The investigators also aim to explore whether the relationship between usage and clinical outcomes is stronger in those using DPT-E compared with DPT-Standard.
- Conditions
- Child Behavior Problem, Parenting, Engagement, Patient
- Being tested
- DPT-Standard, DPT-Enhanced
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPT-StandardBehavioural
The parent training intervention includes 7 modules, recommended to be completed within 7- to 10-weeks period. Module's content includes videos and texts guiding the parent through the training process; interactive features, such as multiple-choice questions with direct feedback. Additional features embedded within the platform include downloadable materials, and a Q\&A section that contains frequently asked questions.
DPT-EnhancedBehavioural
DPT-Enhanced will include all the ingredients of DPT-Standard, but with additional features. The program itself is based on pre-defined decision rules that are either event or time based based on evidence based practice in promoting effective parental engagement. Each component includes a short learning phase, followed by a 1-2 week focusing phase. The focusing phase is designed to encourage and help parents to practice and acquire learned skills in their day-to-day lives, by making these skills more salient in their mind.
| Study group | Role | What they receive |
|---|---|---|
| DPT-standard | Active comparator | A standard digital parent training intervention Receives: Behavioral: DPT-Standard |
| DPT-Enhanced | Experimental | Enhanced digital parent training intervention Receives: Behavioral: DPT-Enhanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Eyberg Child Behavior Inventory (ECBI) at 10 weeks
The ECBI specifies 36 behaviors commonly reported by parents of children with behavior problems. For each behavior the parent specifies how often this problem occurs on a 1-7 Likert scale (1=never; 7=always; higher scores mean worse outcome), and whether this behavior is currently a problem (0=no; 1=yes; higher scores mean worse outcome).
Measured: 10 weeks
Secondary outcomes (8)
change from Baseline Behavior and Feelings Survey Externalizing Problems at 10 weeks
The Behavior and Feelings Survey (BFS) parent report of Externalizing Problems in children and adolescents is based on summing 6 items that measure children's behavior problems on a 0-4 scale (0=not a problem; 4=a very big problem).
Measured: 10 weeks
change from Baseline Parenting Scale (PS) at 10 weeks
Two sub-scales of the Parenting Scale, Over-reactivity (11 items) and Laxness (10 items) will be used in this study. The parent is requested to mark his typical response on a 7-point Likert scale (1-7), when 7 indicates the ineffective spectrum (higher scores mean worse outcome), and 1 indicates the effective spectrum.
Measured: 10 weeks
change from Baseline Alabama Parenting Questionnaire (APQ) positive parenting practices at 10 weeks
3 items, 1 sub-scale: measuring positive parenting practices. Parents will be asked to mark the frequency they use each parental practice on a 5-point scale ranging from 1 (never) to 5 (always; higher scores mean better outcome).
Measured: 10 weeks
change from Baseline Me as a Parent (MAAP) self-efficacy at 10 weeks
4 items, 1 sub-scale measures general parental self-efficacy. Responses range on a 5-point Likert scale from 1 = strongly disagree to 5 = strongly agree (higher scores mean better outcome).
Measured: 10 weeks
change from Baseline Parenting Tasks Checklist (PTC) self-efficacy at 10 weeks
12 items, 2 sub-scales: behavioral self-efficacy (6 items), setting self-efficacy (6 items). Parents are asked to rate each item on a scale ranges from 0 to 100 (0=Certain I can't do it, 100=Certain I can do it; higher scores mean better outcome).
Measured: 10 weeks
Program Usage Time
Time on the platform (measured in minutes)
Measured: through program completion, an average of 10 weeks
Program Logins
Number of user logins to the platform
Measured: through program completion, an average of 10 weeks
Number of Modules completed
The number of program Modules that were completed while using the program
Measured: through program completion, an average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start28 Apr 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 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
- Investigators
- Amit Baumel, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344885
- Sponsor's protocol ID
- 2836
- Status last verified
- May 2023
- First submitted
- 7 Apr 2022
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Intervention Design in Digital Parent Training for Child's Disruptive Behaviors: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT05344885
- Acronym / sponsor ID
- 2836
- Conditions
- Child Behavior Problem, Parenting, Engagement, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 25 Apr 2022 (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.
The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. Parents will be enrolled into one of two digital parent training intervention arms, dedifferentiated by their level of correspondence with the related deign mechanism.
Detailed description
The purpose of this pilot study is to preliminary examine the impact of a design mechanism aimed at increasing engagement in an unguided digital parent training program for child's behavior problems. The design mechanism manipulated in this pilot relates to the extent to which program design promotes a positive behavior change. To achieve these goal two unguided digital parent training interventions, differentiated by their level of design (DPT-Standard vs. DPT-Enhanced), will be tested. This pilot aims to recruit 40-60 parents who report behavior problems in their children who will randomly receive one of the two interventions for 10 weeks.
The impact of DPT-E on user engagement and reported child behavior problems will be assessed based on comparison with DPT-Standard. Parental behaviors and sense of competence will be collected to assess the impact of intervention design on these mechanisms of change. In addition, the role of parents' motivation, and their ability to invest effort in making changes during the intervention will be assessed, to examine whether these variables moderate the impact of intervention's design on the aforementioned relationships. The investigators also aim to explore whether the relationship between usage and clinical outcomes is stronger in those using DPT-E compared with DPT-Standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPT-standard | Active comparator | Behavioral: DPT-StandardA standard digital parent training intervention |
| DPT-Enhanced | Experimental | Behavioral: DPT-EnhancedEnhanced digital parent training intervention |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parents report they have a child between the ages of 3 and 7, who:
- Has externalized behavior problems based on A) Parents report at least 1 of the two first criteria of behavior problems to be above 4 (the middle point) \& the average of all items ≥ 4, on a screening scale that consists of 9 items (on a Likert scale between 1 and 7) that is based on DSM-V symptoms for ODD.
- Parents have access to computer at home with an Internet connection and a smartphone with a mobile data plan.
- Parents can read and understand Hebrew.
Key exclusion criteria (3 listed)
- Parents report that the relevant child has been diagnosed with developmental delay, intellectual disability and/or autism spectrum disorder.
- Parent and/or child are already receiving therapeutic intervention (for the child) in other setting.
- The relevant child is treated with psychiatric medication.
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-StandardThe parent training intervention includes 7 modules, recommended to be completed within 7- to 10-weeks period. Module's content includes videos and texts guiding the parent through the training process; interactive features, such as multiple-choice questions with direct feedback. Additional features embedded within the platform include downloadable materials, and a Q\&A section that contains frequently asked questions. | Behavioural | DPT-standard |
| DPT-EnhancedDPT-Enhanced will include all the ingredients of DPT-Standard, but with additional features. The program itself is based on pre-defined decision rules that are either event or time based based on evidence based practice in promoting effective parental engagement. Each component includes a short learning phase, followed by a 1-2 week focusing phase. The focusing phase is designed to encourage and help parents to practice and acquire learned skills in their day-to-day lives, by making these skills more salient in their mind. | Behavioural | DPT-Enhanced |
Primary outcome
Change from Baseline Eyberg Child Behavior Inventory (ECBI) at 10 weeks
Time frame: 10 weeks
The ECBI specifies 36 behaviors commonly reported by parents of children with behavior problems. For each behavior the parent specifies how often this problem occurs on a 1-7 Likert scale (1=never; 7=always; higher scores mean worse outcome), and whether this behavior is currently a problem (0=no; 1=yes; higher scores mean worse outcome).
8 secondary outcomes
change from Baseline Behavior and Feelings Survey Externalizing Problems at 10 weeks
Time frame: 10 weeks
change from Baseline Parenting Scale (PS) at 10 weeks
Time frame: 10 weeks
change from Baseline Alabama Parenting Questionnaire (APQ) positive parenting practices at 10 weeks
Time frame: 10 weeks
change from Baseline Me as a Parent (MAAP) self-efficacy at 10 weeks
Time frame: 10 weeks
change from Baseline Parenting Tasks Checklist (PTC) self-efficacy at 10 weeks
Time frame: 10 weeks
Program Usage Time
Time frame: through program completion, an average of 10 weeks
Program Logins
Time frame: through program completion, an average of 10 weeks
Number of Modules completed
Time frame: through program completion, an average of 10 weeks
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 17 May 2023.
- Individual participant dataSharing planned: No
Related trials for Child Behavior Problem
Active, not recruiting
A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
Not yet recruiting
Hybrid Pilot of Personalized Parent-Child Interaction Therapy
Disruptive Behaviors
Not yet recruiting
Self-Concept Reinforcement for Early School Readiness
Child Behavior, Child Behavior Problem
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.
Amit Baumel, PhD principal investigator
University of Haifa
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-Standard and DPT-Enhanced in people with Child Behavior Problem and Parenting, 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 5 inclusion and 3 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 17 May 2023. 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?
Change from Baseline Eyberg Child Behavior Inventory (ECBI) at 10 weeks (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2023.