Clinical trial NCT05344885: 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
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problem
Parenting
Engagement, Patient
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 88
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Eyberg Child Behavior Inventory (ECBI) at 10 weeks
timeFrame: 10 weeks
Secondary outcomes:
measure: change from Baseline Behavior and Feelings Survey Externalizing Problems at 10 weeks
timeFrame: 10 weeks
measure: change from Baseline Parenting Scale (PS) at 10 weeks
timeFrame: 10 weeks
measure: change from Baseline Alabama Parenting Questionnaire (APQ) positive parenting practices at 10 weeks
timeFrame: 10 weeks
measure: change from Baseline Me as a Parent (MAAP) self-efficacy at 10 weeks
timeFrame: 10 weeks
measure: change from Baseline Parenting Tasks Checklist (PTC) self-efficacy at 10 weeks
timeFrame: 10 weeks
measure: Program Usage Time
timeFrame: through program completion, an average of 10 weeks
measure: Program Logins
timeFrame: through program completion, an average of 10 weeks
measure: Number of Modules completed
timeFrame: through program completion, an average of 10 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa
name: Amit Baumel, PhD
role: PRINCIPAL_INVESTIGATOR
References: