- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05172297
Internet-based Universal Parent Training as a Booster to PATHS®: Parent Web (PW)
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®
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura Ferrer-Wreder, PhD.,
- Phone Number: +4608163898
- Email: laura.ferrer-wreder@psychology.su.se
Study Locations
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Stockholm, Sweden, SE-106 91
- Recruiting
- Stockholm University
-
Contact:
- Laura Ferrer-Wreder, PhD.,
- Phone Number: +4608163898
- Email: laura.ferrer-wreder@psychology.su.se
-
Principal Investigator:
- Laura Ferrer-Wreder, PhD.,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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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.
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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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
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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.
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura Ferrer-Wreder, PhD.,, Stockholm University
Publications and helpful links
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
- Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Pelham WE Jr, Gnagy EM, Greenslade KE, Milich R. Teacher ratings of DSM-III-R symptoms for the disruptive behavior disorders. J Am Acad Child Adolesc Psychiatry. 1992 Mar;31(2):210-8. doi: 10.1097/00004583-199203000-00006. Erratum In: J Am Acad Child Adolesc Psychiatry 1992 Nov;31(6):1177.
- Malmberg M, Rydell AM, Smedje H. Validity of the Swedish version of the Strengths and Difficulties Questionnaire (SDQ-Swe). Nord J Psychiatry. 2003;57(5):357-63. doi: 10.1080/08039480310002697.
- Criss MM, Shaw DS. Sibling relationships as contexts for delinquency training in low-income families. J Fam Psychol. 2005 Dec;19(4):592-600. doi: 10.1037/0893-3200.19.4.592.
- Wetterborg D, Enebrink P, Lonn Rhodin K, Forster M, Risto E, Dahlstrom J, Forsberg K, Ghaderi A. A pilot randomized controlled trial of Internet-delivered parent training for parents of teenagers. J Fam Psychol. 2019 Oct;33(7):764-774. doi: 10.1037/fam0000541. Epub 2019 Jun 17.
- Ringle JL, Mason WA, Oats RG, Cogua J. Parenting Children and Adolescents (PARCA) scale English to Spanish translation: An investigation of measurement invariance. J Fam Psychol. 2019 Dec;33(8):938-944. doi: 10.1037/fam0000559. Epub 2019 Jul 18.
- Hofmann SG, Kashdan TB. The Affective Style Questionnaire: Development and Psychometric Properties. J Psychopathol Behav Assess. 2010 Jun 1;32(2):255-263. doi: 10.1007/s10862-009-9142-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FoUI-940010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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