Evaluation of a Family-centered Program for Problematic Gaming/Excessive Screen Use (S-FAME)

April 24, 2026 updated by: Region Skane

Evaluation of a Family-centered Program for Problematic Gaming/Excessive Screen Use in a Child and Adolescent Population Within Social Services in Light of the New Social Services Law

The Family-Centered Program for Problematic Gaming and Excessive Screen Use (FAME) is a pioneering initiative designed to address the growing challenges of excessive screen use and gaming among children and adolescents, particularly within family dynamics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Family-Centered Program for Problematic Gaming and Excessive Screen Use (FAME) is a pioneering initiative designed to address the growing challenges of excessive screen use and gaming among children and adolescents, particularly within family dynamics. With digital media becoming one of the most prevalent leisure activities, excessive use has been linked to adverse outcomes, including depression, sleep disturbances, and family conflicts. Despite these concerns, there are no evaluated family-centered interventions in Sweden that address these issues comprehensively. This randomized controlled trial (RCT) aims to evaluate the effectiveness and feasibility of the S-FAME program, developed in collaboration with social services across two municipalities (Lund, Eslöv). The program integrates psychoeducation, cognitive restructuring, and social-emotional learning, focusing on both children and their families. It acknowledges that problematic screen use often develops within family contexts and aims to improve parenting practices and enhance parent-child relationships. The project aligns with the new Social Services Act, which will come into effect in July 2025, emphasizing easily accessible, preventive, and low-threshold interventions-so-called non-means-tested services. By targeting both individual and family needs, the intervention has the potential to reduce societal costs, enhance family well-being, and address health inequalities. With its innovative and scalable design, S-FAME provides a much-needed framework to tackle one of today's most pressing challenges in youth development- excessive screen use. We are a team of researchers with great experience in research as well as clinical work in the field of adolescence, social work and ANDTS (Alkohol, narkotika, droger, tobak och spel). The project is well established within the School of Social Sciences/Medical Faculty at Lund University, as well as within the innovation and development departments of two social services units. PI Emma Claesdotter-Knutsson (ECK), associate professor and senior consultant in child and adolescent psychiatry at Lund University/Region Skåne with major research areas of gaming, gambling and screens use. ECK has extensive clinical expertise and has played a key role at the Swedish Public Health Agency, contributing to the development of recommendations on child digital media use. PI ECK brings extensive experience and formal training in leading collaborative projects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • family conflicts related to screen use
  • spaeks and udnerstand swedish

Exclusion Criteria:

  • se above

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention
The critical components include psychoeducation, cognitive restructuring, and social and emotional learning. The goals are to help children and parents understand the positive and negative aspects of screen use and to prevent related problems and family conflicts. The intervention consist of 4 group mettings parents and children separate. Max 10 children per group
Behavioral: Family-centered Program for Problematic Gaming/Excessive Screen Use in a child and adolescent population within Social Services
The critical components include psychoeducation, cognitive restructuring, and social and emotional learning.his would be the first intervention offering help for both children and their parents. Such an intervention could be beneficial not only to individual families, but also to society at large by reducing societal costs, enhancing family well-being, and addressing health inequalities . the intervention is agroup intervention in 4 sessions with parents in one group and children in one group. The goals are to help children and parents understand the positive and negative aspects of screen use and to prevent related problems and family conflicts. T
Active Comparator: Control
This group will recieve treatment as usual. After final follow up this group will be offered an online parental intervention of 3 sessions
Behavioral: Control
This group will recieve TAU == treat ment as usual depending on the practice at the Social service they belong to

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FCU
Time Frame: Baseline; Post treatment; 1 month post treatment
five items measure parent-child warmth, and three items measure parent-child conflicts
Baseline; Post treatment; 1 month post treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SCREENS-Q (adapted) time (19) • PARCA for assessing aspects of parent-child relationship and parenting practices (22) • FCU five items measure parent-child warmth, and three items measure parent-child conflicts (23)
Time Frame: Baseline; Post treatment; 1 month post treatment
screening form, for valuing children and adolescent´s screen time screening form, for valuing children and adolescent´s screen time screening form, for valuing children and adolescent´s screen time
Baseline; Post treatment; 1 month post treatment
PARCA
Time Frame: Baseline; Post treatment; 1 month post treatment
for assessing aspects of parent-child relationship and parenting practices
Baseline; Post treatment; 1 month post treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lund University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-05262-01

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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