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Family ConflictPWNCT05172297

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

A study testing Parent Web in people with Family Conflict and Family Relations, run by Stockholm University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Parent Web
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
1 siteSweden
Study dates
21 Oct 2022to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Stockholm University

    Stockholm, SE-106 91

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
Parent Web
Keywords
parent training, universal, youth externalizing problems, family conflict, warmth in families

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parent WebBehavioural

    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.

Study groups in NCT05172297
Study groupRoleWhat they receive
Immediate Intervention GroupExperimentalThe 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.
Receives: Behavioral: Parent Web
Wait-List Control GroupOtherThis is a group of parents who are in a wait-list control group and will receive the Parent Web, after pre and post testing.
Receives: Behavioral: Parent Web

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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)

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

    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.

    Measured: 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

  2. Change from baseline in parent rated stress

    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.

    Measured: 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

  3. Change from baseline in parent rated health

    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.

    Measured: 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

  4. Change from baseline in parent rated parents validation of their child's emotions when expressed

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start21 Oct 2022
  3. Primary completion31 Aug 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This is a non-randomized controlled experiment (i.e., quasi-experiment) with a wait-list comparison group
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05172297
Sponsor's protocol ID
FoUI-940010
Acronym
PW
Status last verified
Oct 2024
First submitted
30 Nov 2021
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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)

Publications

  • 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.

    PubMed 9255702

  • 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.

    PubMed 14522609

  • 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.

    PubMed 1564021

  • 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.

    PubMed 16402874

  • 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.

    PubMed 31204818

  • 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.

    PubMed 31318263

  • 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.

    PubMed 6668417

  • 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.

    PubMed 6880820

  • 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.

    PubMed 20495674

  • 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.

    PubMed 37104280

Questions about this trial

What is this clinical trial studying?

A study testing Parent Web in people with Family Conflict and Family Relations, run by Stockholm University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05172297, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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