NCT07245862

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Jan 2028

First Submitted

Initial submission to the registry

September 12, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 30, 2026

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

September 12, 2025

Last Update Submit

April 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • FCU

    five items measure parent-child warmth, and three items measure parent-child conflicts

    Baseline; Post treatment; 1 month post treatment

Secondary Outcomes (2)

  • 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)

    Baseline; Post treatment; 1 month post treatment

  • PARCA

    Baseline; Post treatment; 1 month post treatment

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

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

Interventions

ControlBEHAVIORAL

This group will recieve TAU == treat ment as usual depending on the practice at the Social service they belong to

Control

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

Intervention

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • se above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Psychiatry Clinic

Lund, Sweden

RECRUITING

MeSH Terms

Conditions

Adolescent BehaviorInternet Addiction Disorder

Condition Hierarchy (Ancestors)

BehaviorTechnology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive Behavior

Central Study Contacts

Emma Claesdotter-Knutsson, PhD

CONTACT

Sabina Kapetanovic, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a 2-arm, parallel-group randomized controlled trial (RCT). Social services in three municipalities (Lund, Eslöv) have endorsed the project and provided each a letter of intent. Families seeking help for conflicts related to child digital media use will be invited to participate. Eligible families will be randomly assigned to either the intervention group, receiving the S-FAME program, or the control group, receiving standard care. These groups will be matched based on specific preexisting characteristics. Based on power analyses appx 176 participants will be required to detect a small effect size (d = .03), accounting for potential attrition.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2025

First Posted

November 24, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

April 30, 2026

Record last verified: 2025-11

Locations