NCT05172297

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

October 21, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

November 30, 2021

Last Update Submit

October 10, 2024

Conditions

Keywords

parent traininguniversalyouth externalizing problemsfamily conflictwarmth in families

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in parent rating of child's emotional problems, conduct problems, hyperactivity, peer problems and prosocial behavior

    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

    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

    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 Outcomes (4)

  • Change from baseline in parent rated encouragement of positive behaviors, setting limits, and proactive parenting behaviors

    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

    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

    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

    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

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

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.

Behavioral: Parent Web

Wait-List Control Group

OTHER

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.

Behavioral: Parent Web

Interventions

Parent WebBEHAVIORAL

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.

Immediate Intervention GroupWait-List Control Group

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsParents in the wait list comparison group have children who are matched to the children of parents in the immediate intervention group. And one of the matching criteria are: Wait-list group parents' child's present-day gender is the same as the matched child who's parents are in the immediate intervention group
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm University

Stockholm, SE-106 91, Sweden

Location

Related Publications (10)

  • 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.

    PMID: 9255702BACKGROUND
  • 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.

    PMID: 14522609BACKGROUND
  • 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.

    PMID: 1564021BACKGROUND
  • 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.

    PMID: 16402874BACKGROUND
  • 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.

    PMID: 31204818BACKGROUND
  • 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.

    PMID: 31318263BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • 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.

    PMID: 6880820BACKGROUND
  • 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.

    PMID: 20495674BACKGROUND
  • Olsson TM, Enebrink P, Kapetanovic S, Ferrer-Wreder L, Stalnacke J, Eninger L, Eichas K, Norman A, Lindberg L, Gull IC, Hau HG, Allodi MW, Sedem M. Study protocol for a non-randomized controlled trial of the effects of internet-based parent training as a booster to the preschool edition of PATHS(R): Universal edition of the Parent Web. PLoS One. 2023 Apr 27;18(4):e0284926. doi: 10.1371/journal.pone.0284926. eCollection 2023.

Study Officials

  • Laura Ferrer-Wreder, PhD.,

    Stockholm University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a non-randomized controlled experiment (i.e., quasi-experiment) with a wait-list comparison group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 29, 2021

Study Start

October 21, 2022

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be made available after 6 months from the project completion date.
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)

Locations