NCT07103213

Brief Summary

Background and study aims Many teenagers feel unhappy with their bodies, which can lead to problems like eating disorders, low self-esteem, and depression. Social media plays an important role in shaping how young people see themselves, often promoting unrealistic beauty standards. This study aims to test the effectiveness of a school-based programme called IMPACTREEL, which teaches adolescents how to critically understand social media and improve their relationship with their body using strategies from third-wave psychological therapies. The goal is to help teenagers feel better about their bodies and reduce the risks of developing mental health problems. Who can participate? The study is open to first year high-school adolescents who attend selected secondary schools in the province of Alicante (Spain). Participation is voluntary, and both the students and their parents/legal guardians must give consent to take part. Young people showing severe symptoms of eating disorders will not be included, as they may need clinical treatment. What does the study involve? Participants will be randomly assigned by classroom to one of two groups: The intervention group will receive the IMPACTREEL programme, which consists of seven weekly sessions, each lasting 55 minutes, delivered at school by trained facilitators. The control group will not receive the programme during the study but will be offered it later. Both groups will be asked to complete a series of questionnaires about body image, social media use, emotional well-being, and quality of life before the programme, after it ends, and again 6 months and 12 months later. These questionnaires are confidential and anonymous. What are the possible benefits and risks of participating? Participants in the intervention group may learn new skills to help them manage how they feel about their body and how they use social media. These strategies may also help reduce stress and improve emotional well-being. There are no known risks of taking part in this study. Completing the questionnaires or discussing body image may make some students feel uncomfortable, but they are free to stop participating at any time. No clinical diagnosis or treatment is involved in this study. Where is the study run from? The study is being run by psychologists and researchers from the Universidad Miguel Hernández de Elche (Spain), in collaboration with local secondary schools in the province of Alicante. When is the study starting and how long is it expected to run for? The study started in 2024 and is expected to continue until 2028, including follow-up assessments and data analysis. Who is funding the study? The study is funded by a FPU (Formación del Profesorado Universitario) grant from the Spanish Ministry of Universities, which supports doctoral training and research. Who is the main contact? Main contact: Sheila Fernández García Email: sheila.fernandezg@umh.es Affiliation: Universidad Miguel Hernández de Elche

Trial Health

75
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress40%
Sep 2024Nov 2028

Study Start

First participant enrolled

September 9, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

4.1 years

First QC Date

July 9, 2025

Last Update Submit

August 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in body esteem

    Body esteem will be assessed using one validated questionnaire: the Body Esteem Scale for Adolescents and Adults (BESAA). This tool assesses self-perception and satisfaction with one's own body appearance, weight, and attribution by others. Body self-esteem measures a person's satisfaction or dissatisfaction with his or her own body. The positive appearance and negative appearance subscales assess overall satisfaction or dissatisfaction with physical appearance, including various visual aspects without focusing on a specific ideal. An example item is: "I like the way I look in pictures". The third subscale, weight, focuses on the person's satisfaction with his or her own weight, as in the item: "I am satisfied with my weight". The higher the score, the higher the body esteem. The range of scores is from 18 to 90.

    Baseline, post-intervention (week 9), 6-month follow-up, and 12-month follow-up

Secondary Outcomes (9)

  • Change in self-compassion

    Baseline, post-intervention (week 9), 6-month follow-up, and 12-month follow-up

  • Change in perceived pressure and comparison on social media

    Baseline, post-intervention, 6-month follow-up, 12-month follow-up

  • Change in internalisation of appearance ideals (SATAQ-4)

    Baseline, post-intervention (week 9), 6-month follow-up, and 12-month follow-up

  • Change in social media literacy

    Baseline, post-intervention, 6-month follow-up, 12-month follow-up

  • Change in social media engagement

    Baseline, post-intervention, 6-month follow-up, 12-month follow-up

  • +4 more secondary outcomes

Study Arms (2)

IMPACTREEL Intervention Group

EXPERIMENTAL

Participants in this arm will receive the IMPACTREEL programme, a school-based intervention combining social media literacy and third-wave strategies (e.g., mindfulness, self-compassion). The programme consists of 7 weekly 55-minute group sessions delivered during school hours by trained facilitators.

Behavioral: IMPACTREEL programme

Waitlist Control Group

NO INTERVENTION

Participants in this arm will receive no intervention during the study period but will be offered the IMPACTREEL programme after the final 12-month follow-up assessment. They will complete the same assessments as the intervention group at baseline, post-intervention, and 6- and 12-month follow-ups.

Interventions

The IMPACTREEL programme is a school-based intervention designed to promote positive body image in adolescents. It combines social media literacy education with third-wave strategies, including mindfulness, self-compassion, and psychological flexibility. The intervention consists of 7 weekly group sessions lasting 55 minutes each, delivered by trained psychologists facilitators during school hours. The content targets appearance ideal internalisation, critical thinking about social media, and healthier body image attitudes.

IMPACTREEL Intervention Group

Eligibility Criteria

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

You may qualify if:

  • \- Firts year of high-school.

You may not qualify if:

  • \- Presence of severe symptoms of eating disorders, indicated by a score above 20 on the EAT-26

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Miguel Hernández de Elche

Elche, Alicante, 03202, Spain

Location

Study Officials

  • María José Quiles Sebastián María José Quiles Sebastián, Associate Professor

    Universidad Miguel Hernández de Elche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants are assigned by cluster (classroom) to either an intervention group receiving the IMPACTREEL programme or a waitlist control group. The study uses a parallel group design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maria Jose Quiles Sebastian - Principal Investigator

Study Record Dates

First Submitted

July 9, 2025

First Posted

August 5, 2025

Study Start

September 9, 2024

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

August 5, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) collected during the trial will be pseudo-anonymised and stored securely in accordance with data protection regulations (GDPR and Spanish data protection law). IPD will not be made publicly available to protect participant confidentiality, particularly due to the involvement of minors. However, de-identified and aggregated data may be made available upon reasonable request to the principal investigator, subject to ethical approval and data-sharing agreements.

Locations