Fostering Resilience in Adolescents at Risk.

NCT ID: NCT05133115

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 674 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2022-12-31

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.

Detailed Description

Background Some studies with adolescents reported the impact of Coronavirus disease 2019 (COVID-19) pandemic on the mental health. In the literature, resilience was related with positive mental health and was defined by some authors as a good mental health and a good psychosocial functioning despite exposure to risk or adversity (Collishaw et al., 2016). Additionally, resilience was also considered important to develop interventions to prevent or treat mental disorders, particularly anxiety, depression, and stress. Schools have been identified as one of the key settings for promoting resilience among children and young populations in this time of COVID-19 pandemic, where social inequalities have become even more evident and depressive symptoms have increased. The purpose of this trial is to assess the effectiveness of a resilience school-based intervention in adolescents and to understand whether the school training can improve levels of resilience or increase psychological wellbeing, while reducing depressed mood.

Hypothesis: Adolescents at risk between 12 and 15 years of age who receive a resilience school-based intervention by school nurses, will obtain higher scores on scales of resilience with respect to the control group, just after the intervention and 6-month post-intervention

Method:

The study is a cluster randomized controlled trial (RCT). Schools that want to participate, will sign an agreement to participate in the project Schools will be randomly allocated in control and intervention groups by external researcher using a computer-generated random numbers.

The intervention will be carried out during the school period (January to June 2022), by primary health care nurses who are part of the committee of experts and the research team. Students will follow a specific training consisting of six 55-minute sessions, once a week.

The data collection will start in January 2022 and will finish in December 2022.

Data will be collected at baseline before the intervention (T1), after 6 weeks post- intervention (T2) and 6 months after intervention as follow-up (T3).

The evaluation of the effectiveness of the intervention will be carried out using the psychometric scale CYRM-32 (as the primary outcome) which will allow us to determine changes in resilience.

Using SD of the primary outcome CYRM-32 scale, minimum sample size was calculated to be 70 students in each group, using GRANMO (https://www.imim.es/ofertadeserveis/software-public/granmo/). A follow-up loss rate of 10% was estimated.

Conditions

Resilience, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

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).

Group Type: EXPERIMENTAL

Fostering Resilience in Adolescents at Risk

Intervention Type: 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.

Control Group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fostering Resilience in Adolescents at Risk

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

FRAK

Eligibility Criteria

Inclusion Criteria

• Adolescents aged 12 to 15 in a context of risk ( risk of social exclusion; COVID -19 pandemic context)

Exclusion Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health, Generalitat de Catalunya

OTHER_GOV

Sponsor Role: collaborator

Consorci Sanitari de Terrassa

OTHER

Sponsor Role: lead

Responsible Party

Maria Llistosella

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School Antoni Ubach

Terrassa, Barcelona, Spain

School Goya

Terrassa, Barcelona, Spain

School Mediterrania

Barcelona, , Spain

School IES Can Roca

Terrassa, , Spain

School INS Terrassa

Terrassa, , Spain

School Pere Viver

Terrassa, , Spain

School Torre del Palau

Terrassa, , Spain

School Vedruna

Terrassa, , Spain

Countries

Spain

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 9137124 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26654748 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25012574 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31316419 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39502155 (View on PubMed)

Other Identifiers

02-21-160-016

Identifier Type: -

Identifier Source: org_study_id