Fostering Resilience in Adolescents at Risk.

NCT05133115 | Completed

• 1 other identifier: 02-21-160-016
• Study Type: interventional
• Target: 674
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to assess the effectiveness of a school-based resilience intervention in adolescents and to understand whether the school training can improve levels of resilience or psychological wellbeing, while reducing depressed mood.

Conditions

Resilience, Psychological

Keywords

Adolescent; Population at Risk; Psychological Intervention; Clinical Trials, Randomized

Outcome Measures

Primary Outcomes (2)

• Child Youth Resilience Measure -32

  Changes in level of resilience using the scale Child Youth Resilience Measure -32 (CYRM-32) Child Youth Resilience Measure -32 (CYRM-32) The CYRM-32 includes 32 items is designed to assess resilience in children and young people (aged 12 to 23 years). It is a self-reported measure and for each question, participants use a 5-point Likert scale (1= not at all to 5= a lot (Llistosella et al., 2019).

  Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months

• Brief Resilience Scale

  Changes in level of resilience using the Brief Resilience scale.

  Time 1 baseline, Time 2 post-intervention at week 6 and up to 6 months

Secondary Outcomes (2)

• Emotional Regulation Strategies

  Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months

• Depression Mood

  Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Schools with adolescents aged 12 to 15 in a context at risk. They will follow the intervention for 6 weeks (6 sessions, once a week).

Behavioral: Fostering Resilience in Adolescents at Risk

Control Group

NO INTERVENTION

Schools in the control group will be all waitlisted to receive the intervention during the following academic year should it prove effectiveness. They will fill in the same research questionnaires as the Intervention group and at the same time period (January to December 2022).

Interventions

Fostering Resilience in Adolescents at Risk BEHAVIORAL

The FRAK training was developed according to ecological framework, empirical evidence and contextual information. The contents, components, pedagogy, and technical elements of FRAK were established based on The Individual \& Environmental Resilience Model (IERM). Previous to the intervention, a systematic review and a meta-analysis on Resilience Interventions were performed. Students will follow a training consisting of six 55-minute sessions: (1) introducing resilience, (2) self-esteem, (3) emotional strategies regulation, (4) social skills, (5) solving problems (6) community resources, social and peers' support.

Also known as: FRAK

Intervention Group

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Adolescents aged 12 to 15 who do not want to participate in the activities of the intervention.
• Aged \<12 years or \>15 years

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead
• Department of Health, Generalitat de Catalunya: collaborator

Study Sites (8)

School Antoni Ubach

Terrassa, Barcelona, Spain

Location

School Goya

Terrassa, Barcelona, Spain

Location

School Mediterrania

Barcelona, Spain

Location

School IES Can Roca

Terrassa, Spain

Location

School INS Terrassa

Terrassa, Spain

Location

School Pere Viver

Terrassa, Spain

Location

School Torre del Palau

Terrassa, Spain

Location

School Vedruna

Terrassa, Spain

Location

Related Publications (6)

• Cabello, R., Salguero, J. M., Fernández-Berrocal, P., & Gross, J. J. (2013). A Spanish adaptation of the Emotion Regulation Questionnaire. European Journal of Psychological Assessment, 29(4), 234-240.

  BACKGROUND

• Chochinov HM, Wilson KG, Enns M, Lander S. "Are you depressed?" Screening for depression in the terminally ill. Am J Psychiatry. 1997 May;154(5):674-6. doi: 10.1176/ajp.154.5.674.

  PMID: 9137124 BACKGROUND

• Collishaw S, Hammerton G, Mahedy L, Sellers R, Owen MJ, Craddock N, Thapar AK, Harold GT, Rice F, Thapar A. Mental health resilience in the adolescent offspring of parents with depression: a prospective longitudinal study. Lancet Psychiatry. 2016 Jan;3(1):49-57. doi: 10.1016/S2215-0366(15)00358-2. Epub 2015 Dec 2.

  PMID: 26654748 BACKGROUND

• Limonero JT, Tomas-Sabado J, Gomez-Romero MJ, Mate-Mendez J, Sinclair VG, Wallston KA, Gomez-Benito J. Evidence for validity of the brief resilient coping scale in a young Spanish sample. Span J Psychol. 2014;17:E34. doi: 10.1017/sjp.2014.35.

  PMID: 25012574 BACKGROUND

• Llistosella M, Gutierrez-Rosado T, Rodriguez-Rey R, Liebenberg L, Bejarano A, Gomez-Benito J, Limonero JT. Adaptation and Psychometric Properties of the Spanish Version of Child and Youth Resilience Measure (CYRM-32). Front Psychol. 2019 Jun 28;10:1410. doi: 10.3389/fpsyg.2019.01410. eCollection 2019.

  PMID: 31316419 BACKGROUND

• Llistosella M, Castellvi P, Garcia-Ortiz M, Lopez-Hita G, Torne C, Ortiz R, Guallart E, Una-Solbas E, Carlos Martin-Sanchez J. Effectiveness of a resilience school-based intervention in adolescents at risk: a cluster-randomized controlled trial. Front Psychol. 2024 Oct 22;15:1478424. doi: 10.3389/fpsyg.2024.1478424. eCollection 2024.

  PMID: 39502155 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No-blinded participant groups and personnel (research team).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Eligible schools will be randomly allocated either to an intervention group or control. The clusters were school classrooms (grades 6, 7). For each grade (and 7) there will be several classrooms (clusters) depending of the schools.The randomization procedure will be performed in two steps. First, the schools will be randomly allocated either to an intervention group or control by the external researcher using computer-generated random numbers; second, the external researcher will randomize the intervention group into the different school-levels. According to the minimum estimated sample size (70 participants/group) and knowing that there are 25 to 30 students per classroom, we will need a minimum of three clusters (classrooms) per group.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: January 30, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)