Internet-based Universal Parent Training as a Booster to PATHS®: Parent Web (PW)

March 5, 2024 updated by: Laura Ferrer Wreder, Stockholm University

A Non-randomized Controlled Trial of the Effects of an Internet-delivered Parent Training Intervention (Parent Web) at the Transition to Early Adolescence for Parents of Children That Have Participated in Preschool PATHS®

To test an online parent training program. Relative to a matched comparison, those in the Parent Web (PW) will show benefits on well-being, parenting, stress, youth mental health. Parents of PATHS children are the immediate intervention group.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Parent-Web (PW) is internet delivered and rooted in social learning and coercion theory, PW supports parenting practices and parent-child interactions encouraging prosocial behavior and emotion regulation, reduce coercive parenting, improve communication, problem solving, and warmth. PW has a universal and selective edition. Universal PW has 5 basic modules (1 module per week, 6-8 weeks) and bonus modules. Basic modules contain information, exercises, and videos of actors showing parenting practices. A family guide supports PW participants through PW modules. No published outcome evaluations of universal PW currently exist. However, benefits were found for selective PW. This study will test the effects of universal PW as a booster to PATHS (Promoting Alternative Thinking Strategies) a universal school-based intervention designed to enhance child social emotional competence. All PW trial participants are parents to at least one adolescent child (aged 11-13). Immediate PW participants are parents who have a child that participated in PATHS at age 4-5 years old.

Study Type

Interventional

Enrollment (Estimated)

576

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Stockholm, Sweden, SE-106 91
        • Recruiting
        • Stockholm University
        • Contact:
        • Principal Investigator:
          • Laura Ferrer-Wreder, PhD.,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Immediate intervention group are parents of children aged 11-13 who participated in PATHS at age 4-5 years old.

Parents in the wait list comparison group have children who are matched to the children of parents in the immediate intervention group.

Matching criteria are:

Wait-list group parents' child's present-day gender (matching criteria 1) is the same as the matched child who's parents are in the immediate intervention group, wait-list group parents' child's present-day age is similar to the matched child who's parents are in the immediate intervention group, namely child birthdays within 6 months of each other (matching criteria 2), and wait-list group parents' children live in the same postal code as the matched immediate intervention group child (matching criteria 3), and matched children have all lived in Sweden since 2014 (matching criteria 4). If these 4-matching criteria are too restrictive and do not provide enough matches to recruit from, then the matching criteria will be reduced to points 1, 2, and point 3. Children do not participate in the Parent Web intervention trial, but parents of children do participate.

Exclusion Criteria: See inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Intervention Group
The immediate intervention group will take part in the online parent training program called the Parent Web (PW). This immediate intervention group are parents of PATHS children who took part in a social emotional curriculum (PATHS) at age 4 to 5 years old and during the PW trial will be 11 to 13 years old. Parents are participating in the Parent Web.
Parent-Web (PW) is internet delivered and rooted in social learning and coercion theory, PW supports parenting practices and parent-child interactions encouraging prosocial behavior and emotion regulation, reduce coercive parenting, improve communication, problem solving, and warmth. PW has a universal and selective edition. Universal PW has 5 basic modules (1 module per week, 6-8 weeks) and bonus modules. Basic modules contain information, exercises, and videos of actors showing parenting practices. A family guide supports parents through modules.
Other: Wait-List Control Group
This is a group of parents who are in a wait-list control group and will receive the Parent Web, after pre and post testing.
Parent-Web (PW) is internet delivered and rooted in social learning and coercion theory, PW supports parenting practices and parent-child interactions encouraging prosocial behavior and emotion regulation, reduce coercive parenting, improve communication, problem solving, and warmth. PW has a universal and selective edition. Universal PW has 5 basic modules (1 module per week, 6-8 weeks) and bonus modules. Basic modules contain information, exercises, and videos of actors showing parenting practices. A family guide supports parents through modules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in parent rating of child's emotional problems, conduct problems, hyperactivity, peer problems and prosocial behavior
Time Frame: Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rating of their child's emotional problems, conduct problems, hyperactivity, peer problems and prosocial behavior as indexed by the Strengths and Difficulties Questionnaire (SDQ). The SDQ consists of 25 items rated on a 3-point Likert scale with response options that range from 0 = not true, 1 = somewhat true, 2 = certainly true. Higher scores indicate a worse outcome on the emotional problems, conduct problems, hyperactivity, peer problems scale scores. Higher scores on the prosocial behavior scale indicate a better outcome.
Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline in parent rated view of their child's behavioral problems/defiant behavior
Time Frame: Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent view of their child's behavioral problems/defiant behavior as measured by the Oppositional Defiant Scale of the Disruptive Disorder Rating Scale (DBD) which consists of 7 items rated on a 4-point scale ranging from 1 (not at all) to 4 (very much). Higher scores indicate a worse outcome.
Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline in parent rated family warmth and conflict
Time Frame: Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated warmth and conflict. Warmth and conflict are indexed by eight items rated on a five-point scale from 1 (never) to 5 (more than 7 times). Five items measure parent-child warmth and three items measure parent-child conflicts. Higher scores on parental warmth scale indicate a better outcome. Higher scores on the parent-child conflicts scale score indicate a worse outcome.
Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in parent rated encouragement of positive behaviors, setting limits, and proactive parenting behaviors
Time Frame: Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated encouragement of positive behaviors, setting limits, and proactive parenting behaviors as indexed by the Parenting Children and Adolescents Scale (PARCA). The PARCA has 19 items rated on a five-point scale 1 = never to 5 = Very Often. The scale has three subscales on encouragement of positive behaviors, setting limits, and proactive parenting behaviors. Higher scores indicate a better outcome.
Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline in parent rated stress
Time Frame: Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated stress as measured by the Perceived Stress Scale (PSS). PSS consists of 10 questions about perceived stress during the last month rated on a 5-point Likert scale (0 = Never to 4 = Very Often). The scale measures the extent to which situations in one's life are assessed and perceived as stressful and current stress levels. Higher scores indicate a worse outcome.
Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline in parent rated health
Time Frame: Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated health as measured by the Hospital Anxiety and Depression Scale (HAD). HAD consists of two scales (a total of 14 items), one for anxiety and one for depression with seven questions each. Items are rated on a 4-point Likert scale. Higher scores indicate a worse outcome.
Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline in parent rated parents validation of their child's emotions when expressed
Time Frame: Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1
Change from baseline up to 10 months later (immediate intervention group, two time points) and up to 20 months later (wait-list comparison group, three time points) in parent rated affective style as measured by the tolerating subscale of the Affective Style Questionnaire (ASQ). The ASQ consists of five items (rated on a 3 point Likert scale, 1 = Completely Agree to 3 = Completely Disagree) that examine how parents view their own validation of their child's emotions when expressed. Higher scores indicate a worse outcome.
Immediate PW group pretest in Fall 2022. Post test up to 10 months after pretest. Wait-list group pretest in Fall 2022. Post test 1 up to 10 months after pretest. Post test 2 for wait-list up to 10 months after post test 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laura Ferrer-Wreder, PhD.,, Stockholm University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets to be collected in this trial are not readily available because this study's ethical review does not allow for study data to be in a public repository. For meta-analysis or confirmation of published study results, individual level, de-identified data requests will be reviewed when made by qualified researchers (e.g., Ph.D.) along with ethical permission under Swedish law regarding secondary data analysis. Requests to access the datasets should be directed to Laura Ferrer-Wreder (laura.ferrer-wreder@psychology.su.se)

IPD Sharing Time Frame

Data will be made available after 6 months from the project completion date.

IPD Sharing Access Criteria

The datasets to be collected in this trial are not readily available because this study's ethical review does not allow for study data to be in a public repository. For meta-analysis or confirmation of published study results, individual level, de-identified data requests will be reviewed when made by qualified researchers (e.g., Ph.D.) along with ethical permission under Swedish law regarding secondary data analysis. Requests to access the datasets should be directed to Laura Ferrer-Wreder (laura.ferrer-wreder@psychology.su.se)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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