Resilience, PsychologicalFRAKNCT05133115
Fostering Resilience in Adolescents at Risk.
A study testing Fostering Resilience in Adolescents at Risk in people with Resilience, Psychological, run by Consorci Sanitari de Terrassa at 8 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience, Psychological
- What is being tested?
- Fostering Resilience in Adolescents at Risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 674 participants
- Where
- 8 sitesSpain
- Study dates
- 30 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents aged 12 to 15 in a context of risk ( risk of social exclusion; COVID -19 pandemic context)
Who cannot join
- Adolescents aged 12 to 15 who do not want to participate in the activities of the intervention.
- Aged <12 years or >15 years
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
School Mediterrania
Barcelona
School Antoni Ubach
Terrassa, Barcelona
School Goya
Terrassa, Barcelona
School IES Can Roca
Terrassa
School INS Terrassa
Terrassa
School Pere Viver
Terrassa
School Torre del Palau
Terrassa
School Vedruna
Terrassa
About this study
Official title: Resilience School-Based Intervention in Adolescents at Risk: A Clustered Randomized Control Trial.
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.
Read the 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
- Being tested
- Fostering Resilience in Adolescents at Risk
- Keywords
- Adolescent, Population at Risk, Psychological Intervention, Clinical Trials, Randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fostering Resilience in Adolescents at RiskBehavioural
Also called FRAK
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Time 1 baseline, Time 2 post-intervention at week 6 and up to 6 months
Secondary outcomes (2)
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).
Measured: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months
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).
Measured: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start30 Jan 2022
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Resilience, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Responsible party
- Principal investigator, Maria Llistosella, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133115
- Sponsor's protocol ID
- 02-21-160-016
- Acronym
- FRAK
- Status last verified
- Feb 2023
- First submitted
- 12 Nov 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9137124Collishaw 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.
PubMed 26654748Limonero 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.
PubMed 25012574Llistosella 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.
PubMed 31316419Llistosella 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.
PubMed 39502155
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience School-Based Intervention in Adolescents at Risk: A Clustered Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05133115
- Acronym / sponsor ID
- FRAK / 02-21-160-016
- Conditions
- Resilience, Psychological
- Keywords
- Adolescent, Population at Risk, Psychological Intervention, Clinical Trials, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Fostering Resilience in Adolescents at RiskSchools with adolescents aged 12 to 15 in a context at risk. They will follow the intervention for 6 weeks (6 sessions, once a week). |
| 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). |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adolescents aged 12 to 15 in a context of risk ( risk of social exclusion; COVID -19 pandemic context)
Key exclusion criteria (2 listed)
- Adolescents aged 12 to 15 who do not want to participate in the activities of the intervention.
- Aged <12 years or >15 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fostering Resilience in Adolescents at RiskAlso: FRAKThe 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. | Behavioural | Intervention Group |
Primary outcome
Child Youth Resilience Measure -32
Time frame: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months
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).
Brief Resilience Scale
Time frame: Time 1 baseline, Time 2 post-intervention at week 6 and up to 6 months
Changes in level of resilience using the Brief Resilience scale.
2 secondary outcomes
Emotional Regulation Strategies
Time frame: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months
Depression Mood
Time frame: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- BackgroundCabello, 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: PubMed 9137124Chochinov 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.
- Background: PubMed 26654748Collishaw 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.
- Background: PubMed 25012574Limonero 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.
- Background: PubMed 31316419Llistosella 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.
- Derived from this study: PubMed 39502155Llistosella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fostering Resilience in Adolescents at Risk in people with Resilience, Psychological, run by Consorci Sanitari de Terrassa at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Youth Resilience Measure -32 (time frame: Time 1 baseline, Time 2 post-intervention at week 6 and time 3 up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05133115, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.