NCT05344885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 28, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

April 7, 2022

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    10 weeks

Secondary Outcomes (8)

  • change from Baseline Behavior and Feelings Survey Externalizing Problems at 10 weeks

    10 weeks

  • change from Baseline Parenting Scale (PS) at 10 weeks

    10 weeks

  • change from Baseline Alabama Parenting Questionnaire (APQ) positive parenting practices at 10 weeks

    10 weeks

  • change from Baseline Me as a Parent (MAAP) self-efficacy at 10 weeks

    10 weeks

  • change from Baseline Parenting Tasks Checklist (PTC) self-efficacy at 10 weeks

    10 weeks

  • +3 more secondary outcomes

Study Arms (2)

DPT-standard

ACTIVE COMPARATOR

A standard digital parent training intervention

Behavioral: DPT-Standard

DPT-Enhanced

EXPERIMENTAL

Enhanced digital parent training intervention

Behavioral: DPT-Enhanced

Interventions

DPT-StandardBEHAVIORAL

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-standard
DPT-EnhancedBEHAVIORAL

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.

DPT-Enhanced

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, 3498838, Israel

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Amit Baumel, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 25, 2022

Study Start

April 28, 2022

Primary Completion

November 14, 2022

Study Completion

November 14, 2022

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations