Internet-Based InterventionGStepsNCT05281913
Psychoeducational Simulation Game for Adults in Stepfamilies
A study testing Psychoeducational Game in people with Internet-Based Intervention and Remarriage, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Recent evidence has shown that intervention programs for remarried people are scarce. Furthermore, from what is known, no specific intervention models (traditional or web-based) has yet been developed for remarried Portuguese population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Internet-Based Intervention, Remarriage
- What is being tested?
- Psychoeducational Game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePortugal
- Study dates
- 4 Feb 2022to 4 Apr 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Live in a Stepfamily
- Relationship length minimum of six months
Who cannot join
- Not having (step)children
- Not cohabiting with the spouse
Trial locations and contacts
1 site in 1 country.
Portugal1 site
University of Porto, Faculty of Psychology and Educational and Education Sciences
Porto, 4200-193
About this study
Official title: A Web-based Psychoeducational Simulation Game for Remarried Adults - Study Protocol for a Randomized Controlled Trial.
Recent evidence has shown that intervention programs for remarried people are scarce.
Furthermore, from what is known, no specific intervention models (traditional or web-based) has yet been developed for remarried Portuguese population. This study evaluates the efficacy of a web-based Psychoeducational Simulation Game on marital adjustment on marital social skills, on remarriage beliefs, on parenting attitudes, and on the stepfamily functioning.
Read the detailed description
This study will compare the efficacy of a Simulation Game Intervention versus control (no game) in remarried people that have (step)children. The participants will be randomized to the two groups. The Simulation Game contains three different modules to play: Module 1 - Conjugality (emotional divorce, financial issues, positive communication skills, conflict and stress management strategies, social support); Module 2 - Step-parenting (positive stepparent-stepchild relationships, development of relationships within stepfamily, step-parenting roles negotiation, stepfamily' unrealistic beliefs and develop share meaning); Module 3 - Co-parenting (positive co-parenting strategies and loyalty binds).
- Conditions
- Internet-Based Intervention, Remarriage
- Being tested
- Psychoeducational Game
- Keywords
- remarriage, stepfamily, step-parenting, psychoeducation, web-based interventions, clinic interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational GameOther
Psychoeducational Game
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | A web-based Simulation Game concerning marital positive skills in remarriage, positive co-parenting strategies and positive stepparent-stepchild relationship skills. Receives: Other: Psychoeducational Game |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in marital adjustment
This measure is a self-rating questionnaire to assesses the quality of the dyadic relationship with three subscales: Consensus, Satisfaction and Cohesion.
Measured: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Change in marital social skills
This measure is a 32-item self-report measure that evaluates the frequency with which people present certain social skills in the context of their marital relationship.
Measured: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Secondary outcomes (4)
Change in Step-parenting Attitudes and Beliefs
Seventeen items were used to rate the participants' step-parenting attitudes and beliefs addressed in the program content.
Measured: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Change in Co-parenting Attitudes and Beliefs
Nine items were used to rate the participants' co-parenting attitudes and beliefs addressed in the program content.
Measured: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Change in remarriage Beliefs
This measure is a self-rating questionnaire to assesses participants' unrealistic beliefs regarding remarriage and stepfamilies in general.
Measured: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Change in stepfamily functioning
This measure is a self-report questionnaire to provide an evaluation of family functioning with 5 items and three dimensions: Family strengths, Family communication and Family difficulties.
Measured: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start4 Feb 2022
- Primary completion4 Jan 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet-Based InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
- Investigators
- Carina Santos, MSc, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281913
- Sponsor's protocol ID
- FPCEUP/RH4
- Acronym
- GSteps
- Status last verified
- Nov 2022
- First submitted
- 24 Feb 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Psychoeducational Simulation Game for Remarried Adults - Study Protocol for a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05281913
- Acronym / sponsor ID
- GSteps / FPCEUP/RH4
- Conditions
- Internet-Based Intervention, Remarriage
- Keywords
- remarriage, stepfamily, step-parenting, psychoeducation, web-based interventions, clinic interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent evidence has shown that intervention programs for remarried people are scarce.
Furthermore, from what is known, no specific intervention models (traditional or web-based) has yet been developed for remarried Portuguese population. This study evaluates the efficacy of a web-based Psychoeducational Simulation Game on marital adjustment on marital social skills, on remarriage beliefs, on parenting attitudes, and on the stepfamily functioning.
Detailed description
This study will compare the efficacy of a Simulation Game Intervention versus control (no game) in remarried people that have (step)children. The participants will be randomized to the two groups. The Simulation Game contains three different modules to play: Module 1 - Conjugality (emotional divorce, financial issues, positive communication skills, conflict and stress management strategies, social support); Module 2 - Step-parenting (positive stepparent-stepchild relationships, development of relationships within stepfamily, step-parenting roles negotiation, stepfamily' unrealistic beliefs and develop share meaning); Module 3 - Co-parenting (positive co-parenting strategies and loyalty binds).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Psychoeducational GameA web-based Simulation Game concerning marital positive skills in remarriage, positive co-parenting strategies and positive stepparent-stepchild relationship skills. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Live in a Stepfamily
- Relationship length minimum of six months
Key exclusion criteria (2 listed)
- Not having (step)children
- Not cohabiting with the spouse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational GamePsychoeducational Game | Other | Intervention Group |
Primary outcome
Change in marital adjustment
Time frame: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
This measure is a self-rating questionnaire to assesses the quality of the dyadic relationship with three subscales: Consensus, Satisfaction and Cohesion.
Change in marital social skills
Time frame: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
This measure is a 32-item self-report measure that evaluates the frequency with which people present certain social skills in the context of their marital relationship.
4 secondary outcomes
Change in Step-parenting Attitudes and Beliefs
Time frame: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Change in Co-parenting Attitudes and Beliefs
Time frame: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Change in remarriage Beliefs
Time frame: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Change in stepfamily functioning
Time frame: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina Santos, MSc principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational Game in people with Internet-Based Intervention and Remarriage, run by Universidade do Porto at 1 site in Portugal.
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 2 inclusion and 2 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 30 Jul 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 Portugal. 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 in marital adjustment (time frame: T0 - before the intervention; T1 - immediately after intervention; T2 - one month later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.