Fostering Resilience in Adolescents at Risk.

Resilience, Psychological Clinical Trial

— FRAK  

Official title:

Resilience School-Based Intervention in Adolescents at Risk: A Clustered Randomized Control Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05133115
• Other study ID #: 02-21-160-016
• Status: Completed
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Resilience, Psychological

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	School Mediterrania	Barcelona
Spain	School Antoni Ubach	Terrassa	Barcelona
Spain	School Goya	Terrassa	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

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa	Department of Health, Generalitat de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Emotional Regulation Strategies	Emotion Regulation Questionnaire (ERQ) The ERQ is a self-report questionnaire, adapted in Spain by Cabello et al. (2013). It will be used to assess two emotion regulation strategies: cognitive reappraisal (6 items) and expressive suppression (4 items). Participants will answer using a 7-point Likert scale (1= strongly disagree, 7= strongly agree).	Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months
Secondary	Depression Mood	Item "Are You Depressed or Sad?" This item will assess the depression mood of the participants. It was adapted from the "Are you depressed?" Screening for depression in the terminally ill (Chochinov et al., 1997) and it is evaluate through numeric scale of 0-10 (0-not depressed, 10-worst possible depression).	Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months