Selective Prevention Transdiagnostic Intervention for At-risk Adolescents With Booster Sessions. (PROCARE+ 2.0)

NCT06185049 | Completed DMC

• 1 other identifier: UJA_PROARE+ 2.0
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Emotional disorders such as anxiety and depression are significantly underdiagnosed and undertreated, even though they are some of the most prevalent mental health conditions, especially among young individuals. Approximately 50% of mental health disorders manifest by the age of 14, and around 75% appear by the age of 24, underscoring the critical importance of addressing these issues during adolescence. Unfortunately, during this developmental stage, early warning signs and even fully developed clinical conditions often go unnoticed, undiagnosed, and untreated. Nonetheless, there is a lack of established, evidence-backed procedures aimed at reaching out to adolescents at risk of developing emotional disorders. Urgently required is a fundamental shift in our approach by creating intervention protocols that allow for the early identification and treatment of at-risk adolescents, thus averting the potential development of severe mental health disorders as they mature. The selective prevention of mental health issues is a crucial element in assisting at-risk adolescents in flourishing before emotional disorders progress. To address this gap, PROCARE+ was conceived as a modularized selective prevention program for adolescents aged 12 to 18 years. Using a personalized medicine approach, PROCARE+ successfully allowed for the adaptation of intervention protocols according to the specific needs of each individual, while also identifying vulnerable individuals based on risk factors. This research aims to maximize and extend the impact on the adolescent population in the post-COVID-19 pandemic stage and will analyze the effectiveness of implementing booster sessions. PROCARE + stratifies adolescents based on their risk and resilience status and will deliver, alongside a core intervention, new specific add-on modules designed to address risk factors identified by adolescents: : 1) Situations of rejection, bullying, and cyberbullying; 2) Addiction to new technologies such as video games or mobile phones and other substances like alcohol, tobacco, and drugs; 3) Improvement of healthy lifestyle habits related to nutrition, sleep, and physical activity; 4) Enhancement of stress-related situations: Ecoanxiety or exam-related anxiety; and 5) Improvement of parent-child relationships and situations of high expressed emotion (parent module). In addition, the study of booster sessions will be further explored to maintain the results following the initial intervention (which is based on core and additional modules according to identified risk factors). To achieve this, a randomized controlled trial with three conditions will be conducted. Adolescents will be assigned to different experimental groups with or without booster sessions in order to increase the effectiveness of the intervention. The objective is to reduce the impact of risk factors and enhance protective factors, ultimately leading to lasting positive outcomes for adolescents. It will combine quantitative analyses, with a special focus on vulnerable groups in a disaggregated approach by sex, gender, sexual orientation, and socioeconomic status. The PROCARE project is expected to have a significant impact. Its outcomes will continue to contribute to the identification and preventive treatment of adolescents at risk of emotional mental disorders at an early stage, before they incur personal, social, and economic costs. This aims to provide new data to help improve personalized preventive medicine. It will be designed to be an acceptable, scalable, and sustainable selective prevention program, striving to increase its effectiveness beyond the context of the COVID-19 pandemic, ultimately contributing to the prevention and reduction of the prevalence of mental disorders in young people.

Conditions

Anxiety Disorders and Symptoms Depressive Symptoms; Risk Factors (Rejection, Bullying/Cyberbullying, Addictions, Healthy Lifestyle Habits, Exam Stress Management, Ecoanxiety, Expressed Emotion)

Keywords

ADOLESCENCE; TRANSDIAGNOSTIC SELECTIVE PREVENTION; RISK FACTOR; REJECTION, BULLYING/CYBERBULLYING; ADDICTIONS; HEALTHY LIFESTYLE HABITS; ECOANXIETY; EXAM STRESS; EXPRESSED EMOTION

Outcome Measures

Primary Outcomes (3)

• The Strengths and Difficulties Questionnaire SDQ

  The study's primary outcome was self-reported risk and protective factors level of emotional disorders as assessed by Strengths and Difficulties Questionnaire (SDQ). Only 5 items of the emotional problems subscale of the self-reported version for adolescents (Self-Reported SDQ) was used. And 5 items of the emotional problems subscale of the parent version (Parent SDQ). Items with Likert-type response format scored from 0 to 2. Higher scores mean a worse outcome.

  Baseline to 12 months after start of interventions]

• Resilience

  Self-reported resilience, as measured by Connor-Davidson Resilience Scale (CD-RISC-10).10 items with a Likert-type response format from 0 to 4. Total scores range from 0 to 40. Higher scores mean a better outcome.

  Baseline to 12 months after start of interventions]

• Health-related quality of life

  Self-reported changes in health-related quality of life as assessed by self-reported changes in health-related quality of life as assessed by KIDSCREEN-10. This instrument contains 10 items with a Likert-type response form ranging from 1 to 4. Total scores range from 10 to 40. Higher scores mean a better outcome.

  Baseline to 12 months after start of interventions]

Secondary Outcomes (3)

• Emotion regulation skills

  Baseline to 12 months after start of interventions]

• Psychological flexibility

  Baseline to 12 months after start of interventions]

• Self-reported anxiety and mood symptomatology

  Baseline to 12 months after start of interventions]

Other Outcomes (7)

• Ecoanxiety

  Baseline to 12 months after start of interventions]

• Exam anxiety

  Baseline to 12 months after start of interventions]

• Social exclusion

  Baseline to 12 months after start of interventions]

Study Arms (3)

PROCARE+ (Core intervention with add-on modules) and two booster sessions, at 6 and 12 months

EXPERIMENTAL

In addition to core UP-A preventive intervention, PROCARE + will apply an innovative personalized medicine approach by adding specific modules according to the risk factor evidenced by adolescents. Different modules will be suited for the stratified groups in a more personalized format. Add-on young-focused modules would include: rejection, bullying/cyberbullying, addictions, healthy lifestyle habits, exam stress management, ecoanxiety, parental expressed emotion. Two booster sessions would be included (at 6 and 12 months).

Behavioral: PROCARE+ (Core intervention with add-on modules) and two booster sessions.

PROCARE+ (Core intervention with add-on modules) and a booster session at 6 months.

EXPERIMENTAL

In addition to core UP-A preventive intervention, PROCARE + will apply an innovative personalized medicine approach by adding specific modules according to the risk factor evidenced by adolescents. Different modules will be suited for the stratified groups in a more personalized format. Add-on young-focused modules would include: rejection, bullying/cyberbullying, addictions, healthy lifestyle habits, exam stress management, ecoanxiety, parental expressed emotion. A booster sessions would be included at 6 months.

Behavioral: PROCARE+ (Core intervention with add-on modules) and one booster session

PROCARE+ (Core intervention with add-on modules) without booster sessions

EXPERIMENTAL

In addition to core UP-A preventive intervention, PROCARE + will apply an innovative personalized medicine approach by adding specific modules according to the risk factor evidenced by adolescents. Different modules will be suited for the stratified groups in a more personalized format. Add-on young-focused modules would include: rejection, bullying/cyberbullying, addictions, healthy lifestyle habits, exam stress management, ecoanxiety, parental expressed emotion. Only follow-up would be conducted up to 12 months.

Behavioral: PROCARE+ (Core intervention with add-on modules) without booster sessions.

Interventions

PROCARE+ (Core intervention with add-on modules) and two booster sessions. BEHAVIORAL

The modules will primarily involve therapeutic sessions aimed at equipping adolescents with strategies for addressing risky situations, including enhancing their communication skills and developing coping mechanisms for stress management. The group sessions will also incorporate education on the importance of open discussions about thoughts, emotions, and behavior as integral components of emotional well-being, with a strong focus on offering support tailored to the identified risk factors. It will include two booster sessions at 6 and 12 months into the intervention.

Also known as: PROCARE+ two booster sessions.

PROCARE+ (Core intervention with add-on modules) and two booster sessions, at 6 and 12 months

PROCARE+ (Core intervention with add-on modules) and one booster session BEHAVIORAL

The modules will primarily involve therapeutic sessions aimed at equipping adolescents with strategies for addressing risky situations, including enhancing their communication skills and developing coping mechanisms for stress management. The group sessions will also incorporate education on the importance of open discussions about thoughts, emotions, and behavior as integral components of emotional well-being, with a strong focus on offering support tailored to the identified risk factors. It will include abooster sessions at 6 months into the intervention.

Also known as: PROCARE+ one booster session

PROCARE+ (Core intervention with add-on modules) and a booster session at 6 months.

PROCARE+ (Core intervention with add-on modules) without booster sessions. BEHAVIORAL

The modules will primarily involve therapeutic sessions aimed at equipping adolescents with strategies for addressing risky situations, including enhancing their communication skills and developing coping mechanisms for stress management. The group sessions will also incorporate education on the importance of open discussions about thoughts, emotions, and behavior as integral components of emotional well-being, with a strong focus on offering support tailored to the identified risk factors.

Also known as: PROCARE+ without booster sessions

PROCARE+ (Core intervention with add-on modules) without booster sessions

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• written informed consent from adolescent and legal guardian
• able to attend prevention modules on his/her own
• Strengths and Difficulties Questionnaire "unlikely" or "possible diagnoses"
• score on Connor-Davidson Resilience Scale as low or medium resilient,
• score below cut-off for Revised Child Anxiety and Depression Scale-30
• absence of anxiety and/or mood disorders
• not receiving psychological or psychiatric treatment
• not presenting acute suicidality and (9) absence of neurodevelopmental disorders.

Sponsors & Collaborators

• University of Jaén: lead
• Universidad Miguel Hernandez de Elche: collaborator
• University Rovira i Virgili: collaborator

Study Sites (1)

University of Jaen

Jaén, Jaen, Spain

Location

Related Publications (7)

• Garcia-Escalera J, Valiente RM, Sandin B, Ehrenreich-May J, Prieto A, Chorot P. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: An Initial Cluster Randomized Wait-List-Controlled Trial. Behav Ther. 2020 May;51(3):461-473. doi: 10.1016/j.beth.2019.08.003. Epub 2019 Aug 14.

  PMID: 32402261 BACKGROUND

• Sandin B, Garcia-Escalera J, Valiente RM, Espinosa V, Chorot P. Clinical Utility of an Internet-Delivered Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (iUP-A): A Pilot Open Trial. Int J Environ Res Public Health. 2020 Nov 10;17(22):8306. doi: 10.3390/ijerph17228306.

  PMID: 33182711 BACKGROUND

• Levin L, Henderson HA, Ehrenreich-May J. Interpersonal predictors of early therapeutic alliance in a transdiagnostic cognitive-behavioral treatment for adolescents with anxiety and depression. Psychotherapy (Chic). 2012 Jun;49(2):218-230. doi: 10.1037/a0028265.

  PMID: 22642525 BACKGROUND

• Queen AH, Barlow DH, Ehrenreich-May J. The trajectories of adolescent anxiety and depressive symptoms over the course of a transdiagnostic treatment. J Anxiety Disord. 2014 Aug;28(6):511-21. doi: 10.1016/j.janxdis.2014.05.007. Epub 2014 Jun 2.

  PMID: 24960439 BACKGROUND

• Bilek EL, Ehrenreich-May J. An open trial investigation of a transdiagnostic group treatment for children with anxiety and depressive symptoms. Behav Ther. 2012 Dec;43(4):887-97. doi: 10.1016/j.beth.2012.04.007. Epub 2012 May 1.

  PMID: 23046789 BACKGROUND

• Ehrenreich-May J, Rosenfield D, Queen AH, Kennedy SM, Remmes CS, Barlow DH. An initial waitlist-controlled trial of the unified protocol for the treatment of emotional disorders in adolescents. J Anxiety Disord. 2017 Mar;46:46-55. doi: 10.1016/j.janxdis.2016.10.006. Epub 2016 Oct 17.

  PMID: 27771133 BACKGROUND

• Vivas-Fernandez M, Garcia-Lopez LJ, Piqueras JA, Muela-Martinez JA, Canals-Sans J, Espinosa-Fernandez L, Jimenez-Vazquez D, Diaz-Castela MDM, Morales-Hidalgo P, Rivera M, Ehrenreich-May J. Randomized controlled trial for selective preventive transdiagnostic intervention for adolescents at risk for emotional disorders. Child Adolesc Psychiatry Ment Health. 2023 Jun 23;17(1):77. doi: 10.1186/s13034-023-00616-9.

  PMID: 37353831 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Rejection, Psychology; Bullying; Cyberbullying; Behavior, Addictive

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Social Behavior; Aggression; Harassment, Non-Sexual; Compulsive Behavior; Impulsive Behavior

Study Officials

• LuisJoaquin Garcia-Lopez, PhD

  University of Jaen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The effects of an intervention with two booster sessions will be evaluated in parallel with an intervention that only has one booster session and with an intervention without booster sessions.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 29, 2023
• Study Start: March 23, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

ES (1)