Clinical trial NCT05133115: Fostering Resilience in Adolescents at Risk.
Official title: Resilience School-Based Intervention in Adolescents at Risk: A Clustered Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience, Psychological
Keywords: Adolescent
Population at Risk
Psychological Intervention
Clinical Trials, Randomized
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
First posted: 2021-11-24
Enrollment: 674
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Child Youth Resilience Measure -32
timeFrame: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months
measure: Brief Resilience Scale
timeFrame: Time 1 baseline, Time 2 post-intervention at week 6 and up to 6 months
Secondary outcomes:
measure: Emotional Regulation Strategies
timeFrame: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months
measure: Depression Mood
timeFrame: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: School Antoni Ubach
state: Barcelona
city: Terrassa
country: Spain
facility: School Goya
state: Barcelona
city: Barcelona
country: Spain
facility: School Mediterrania
city: Terrassa
country: Spain
facility: School IES Can Roca
city: Terrassa
country: Spain
facility: School INS Terrassa
city: Terrassa
country: Spain
facility: School Pere Viver
city: Terrassa
country: Spain
facility: School Torre del Palau
city: Terrassa
country: Spain
facility: School Vedruna
Study officials:
References:
citation: 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.
citation: 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.
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.
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.
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.