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A Pilot Trial Examining Digital Parent Training Programs

Primary Purpose

Child Behavior Problem, Parenting, Engagement, Patient

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
DPT-Standard
DPT-Enhanced
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Behavior Problem

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Parents report they have a child between the ages of 3 and 7, who:
  2. 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.

    B) Parents report ECBI Problems to be above 14 OR Intensity to be above 130.

  3. Parents have access to computer at home with an Internet connection and a smartphone with a mobile data plan.
  4. Parents can read and understand Hebrew.

Exclusion Criteria:

  1. Parents report that the relevant child has been diagnosed with developmental delay, intellectual disability and/or autism spectrum disorder.
  2. Parent and/or child are already receiving therapeutic intervention (for the child) in other setting.
  3. The relevant child is treated with psychiatric medication.

Sites / Locations

  • University of Haifa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DPT-standard

DPT-Enhanced

Arm Description

A standard digital parent training intervention

Enhanced digital parent training intervention

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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).
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).
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).
Program Usage Time
Time on the platform (measured in minutes)
Program Logins
Number of user logins to the platform
Number of Modules completed
The number of program Modules that were completed while using the program

Full Information

First Posted
April 7, 2022
Last Updated
May 16, 2023
Sponsor
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT05344885
Brief Title
A Pilot Trial Examining Digital Parent Training Programs
Official Title
Examining the Impact of Intervention Design in Digital Parent Training for Child's Disruptive Behaviors: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
November 14, 2022 (Actual)
Study Completion Date
November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Problem, Parenting, Engagement, Patient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DPT-standard
Arm Type
Active Comparator
Arm Description
A standard digital parent training intervention
Arm Title
DPT-Enhanced
Arm Type
Experimental
Arm Description
Enhanced digital parent training intervention
Intervention Type
Behavioral
Intervention Name(s)
DPT-Standard
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DPT-Enhanced
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Eyberg Child Behavior Inventory (ECBI) at 10 weeks
Description
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).
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
change from Baseline Behavior and Feelings Survey Externalizing Problems at 10 weeks
Description
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).
Time Frame
10 weeks
Title
change from Baseline Parenting Scale (PS) at 10 weeks
Description
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.
Time Frame
10 weeks
Title
change from Baseline Alabama Parenting Questionnaire (APQ) positive parenting practices at 10 weeks
Description
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).
Time Frame
10 weeks
Title
change from Baseline Me as a Parent (MAAP) self-efficacy at 10 weeks
Description
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).
Time Frame
10 weeks
Title
change from Baseline Parenting Tasks Checklist (PTC) self-efficacy at 10 weeks
Description
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).
Time Frame
10 weeks
Title
Program Usage Time
Description
Time on the platform (measured in minutes)
Time Frame
through program completion, an average of 10 weeks
Title
Program Logins
Description
Number of user logins to the platform
Time Frame
through program completion, an average of 10 weeks
Title
Number of Modules completed
Description
The number of program Modules that were completed while using the program
Time Frame
through program completion, an average of 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. B) 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Baumel, PhD
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Haifa
City
Haifa
ZIP/Postal Code
3498838
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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A Pilot Trial Examining Digital Parent Training Programs

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