Selective Prevention Transdiagnostic Intervention for At-risk Adolescents

NCT04851366 | Completed DMC

• 1 other identifier: PID2019-111138RB-I00
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 3

Brief Summary

Emotional disorders (anxiety and/or depression) are severely undiagnosed and untreated despite being among the most common mental disorders, particularly at a young age. Half of all mental disorders begin by age 14; three-quarters by age 24, which makes adolescence a particularly crucial stage. In adolescence, prodromal signs of mental disorders and even full-blown clinical conditions often remain undetected, undiagnosed and untreated. However, there is an absence of evidence-based protocols to reach at-risk youth for developing emotional disorders. There is an urgent need for a paradigm shift by developing intervention protocols to early identify and treat at-risk adolescents, thus preventing them from developing severe mental disorders later on in life. Mental health selective prevention is key to helping at-risk adolescents thrive before emotional disorder evolves. To cover this gap, PROCARE is conceptualized as a modularized selective preventive programme for adolescents aged 12 to 18 years. Using personalized medicine approach, PROCARE will allow to tailor intervention protocols according to the particular needs of an individual, but also to identify vulnerable people according to risk factors. Adolescents will be stratified based on risk and resilience status and allocated to a 3-arm intervention trial, delivered as a group, face-to-face or telehealth format, depending on Covid19 restrictions imposed by government. By the very first time, PROCARE as selective intervention for at-risk adolescents will deliver specific add-on modules to tackle risk factors evidenced by adolescents, along with a core intervention. The PROCARE protocol aims to reduce the effect of risk factors and enhance protective factors that will eventually lead to lasting positive effects for adolescents. PROCARE will combine quantitative analysis, with special attention to vulnerable groups in a sex/gender disaggregated way. The PROCARE project is expected to have a far impact ultimately contributing to preventing and reducing the prevalence of mental disorders in the young. The outcomes of PROCARE will contribute to identifying and treating adolescents at risk for emotional mental at an early stage, before they incur personal, societal and economic cost. PROCARE will be culturally-adapted and implemented as a multicenter Randomized-Controlled Trial (RCT). PROCARE will be designed to be an acceptable, scalable, and sustainable selective prevention program.

Conditions

Anxiety Disorders and Symptoms; Depressive Symptoms

Keywords

ADOLESCENCE; TRANSDIAGNOSTIC; SELECTIVE PREVENTION; Randomized-Controlled Trial; AT-RISK

Outcome Measures

Primary Outcomes (3)

• Factors associated with adolescents' mental health

  The study's primary outcome was self-reported risk and protective factors level of emotional disorders as assessed by Strengths and Difficulties Questionnaire (SDQ). Total scores range from 0 to 50. 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). Total scores range from 0 to 100. Higher scores mean a better outcome.

  Baseline to 12 months after start of interventions

• Health-related quality of life

  Secondary outcome assessed included self-reported changes in health-related quality of life as assessed by KIDSCREEN-10. Total scores range from 10 to 50. 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

Study Arms (3)

PROCARE+ (with add-on modules)

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, but not limited to social, parental, stress-related (including CoVid19 impact) risk factors, and health. Dosage (number of modules) will be included as covariate in all subsequent analyses.

Behavioral: PROCARE+ (with add-on modules)

PROCARE (UP-A for selective purposes)

EXPERIMENTAL

To ensure cost-effectiveness, PROCARE core intervention will be designed as a brief 8-session child-focused programme which aims to build resilience for adolescents by adapting the core modules from UP-A, along with one individual session with adolescent and parents. Sessions will be delivered in reduced groups, using a typical selective preventive intervention format focused on cost-effectiveness.

Behavioral: PROCARE (UP-A for selective purposes)

Active control condition.

ACTIVE COMPARATOR

The active control condition will be based on the "U talk programme" developed by Prf. Jill Ehrenreich-May at University of Miami and colleagues. It follows a similar structure as the UP-A original programme and allows for two alternative compare conditions to PROCARE. The U Talk programme support-based group condition will be used as active control condition.

Behavioral: Active control condition

Interventions

PROCARE+ (with add-on modules) BEHAVIORAL

The modules will mainly consist in therapy sessions to provide the adolescents with tools to confront risk situations such as communication skills, coping skills to manage stress, etc. The group will include education about discussing thoughts, feelings, and behaviour as parts of emotion, and emphasis on providing support around the specific risks factors detected.

PROCARE+ (with add-on modules)

PROCARE (UP-A for selective purposes) BEHAVIORAL

This core intervention is meant to respond to the heterogeneity inherent in emotional difficulties presentation by extinguishing distress associated with the presentation of heightened negative emotion in general and reduction or elimination of resultant emotionally-driven behaviours, including avoidance, escape, aggression, and controlling behaviours (e.g., reassurance seeking) that reinforce emotional distress intensity over time.

PROCARE (UP-A for selective purposes)

Active control condition BEHAVIORAL

Psychoeducation about many different emotions, emphasis on discussing thoughts, feelings, and behavior as parts of emotion, and emphasis on providing support around generally distressing events.

Active control condition.

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• 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
• University of Miami: collaborator

Study Sites (3)

Universidad Miguel Hernandez

Elche, Alicante, 03202, Spain

Location

University of Jaen

Jaén, Jaen, 23071, Spain

Location

Universitat Rovira i Virgili

Tarragona, 43003, Spain

Location

Related Publications (6)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• LuisJoaquin Garcia-Lopez, PhD

  University of Jaen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A three-armed simple-blind RCT will be conducted.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two interventions are evaluated in parallel against a active control group

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 20, 2021
• Study Start: September 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)