Indicated Prevention Transdiagnostic Intervention for Adolescents At High Risk of Emotional Problems

Depressive Symptoms Clinical Trial

— PROCARE-I  

Official title:

Indicated Prevention Transdiagnostic Intervention for Adolescents At High Risk of Emotional Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252026
• Other study ID #: UJA-PROCARE-I
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 high risk youth for developing emotional disorders. There is an urgent need for a paradigm shift by developing intervention protocols to early identify and treat vulnerable adolescents, thus preventing them from developing severe mental disorders later on in life. Mental health indicated prevention is key to helping at-high risk adolescents thrive before emotional disorder evolves. To cover this gap, PROCARE-I is conceptualized as a modularized indicated preventive programme for adolescents aged 12 to 18 years, adapting UP-A protocol with author's permission and supervision. Adolescents will be allocated to a 2-arm intervention trial, delivered as a group, as telehealth format as a result of Covid19 restrictions imposed by government. The PROCARE-I protocol aims to enhance protective factors that will eventually lead to lasting positive effects for adolescents. PROCARE-I will combine quantitative analysis, with special attention to vulnerable groups in a sex/gender disaggregated way. The PROCARE-I project is expected to have a far impact ultimately contributing to preventing and reducing the prevalence of emotional disorders in the young. The outcomes of PROCARE-I will contribute to identifying and treating vulnerable adolescents at high risk for emotional mental at an early stage, before they incur personal, societal and economic cost. PROCARE-I will be culturally-adapted and implemented as a multicenter Randomized-Controlled Trial (RCT). PROCARE-I will be designed to be an acceptable, scalable, and sustainable indicated prevention program.

Description:

The general objective of PROCARE-I is to design, implement and evaluate a indicated 8-session preventive group intervention for adolescents aged 12-18 at high risk of emotional disorders like anxiety and depression. The intervention will be based on the Unified protocol for transdiagnostic treatment of emotional disorders in adolescents (UP-A), already proven as effective in the US, but adapted with indicated prevention purposes in Spain thanks support of main author of the protocol (Prf. Ehrenreich-May). It will be culturally-adapted and designed to be an acceptable, scalable, and sustainable indicated prevention program. METHODOLOGY The methodology was designed in order to achieve the project's objective of treating vulnerable adolescents at high risk of developing emotional disorders. PROCARE-I working plan will be divided into 3 interconnected stages. Firstly, in order to identify adolescents at high risk of suffering emotional disorders (anxiety and depression), the following self-reports will be administered to adolescents: Strengths and Difficulties Questionnaire (SDQ) to evaluate adolescents at-risk of emotional disorders, and the Revised Child Anxiety and Depression Scale-30 (RCADS-30) will screen for presence/absence of emotional symptomatology. Finally, ADIS5-C/P will be administered to rule-out presence of anxiety and/or mood disorders. Valuing voices from stakeholders and end-users, the investigators will focus on the study of the influence of the above described variables. Third, the investigators will test a indicated preventive intervention using multi-center randomized control trial in Spain. Special attention will be paid to particularly vulnerable young people, such as disabled, refugees, immigrants, or minorities (national, ethnic, linguistic, religious, and sexual). IMPACT The need to include mental health among the first priorities of the public health agenda has been increasingly recognized over the past decades. The outcomes of the PROCARE-I project will have a far impact ultimately contributing to preventing and reducing the prevalence of mental disorders in the young. These problems are wide-ranging, long-lasting, and enormous and impose a range of costs on individuals, families and communities. The outcomes of the project, if successful, will have far reaching implications, contributing to identifying and treating adolescents at high risk for emotional mental disorders at an early stage, before they incur personal, societal and economic cost.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• written informed consent from adolescent and legal guardian
• able to attend prevention modules on his/her own
• language competence
• Strengths and Difficulties Questionnaire ""probable diagnoses"
• score above cut-off for Revised Child Anxiety and Depression Scale-30
• absence of anxiety and/or mood disorders

Exclusion Criteria:

• in- or outpatient
• concomitant psychological/psychiatric treatment
• acute suicidality
• general medical contraindications that hamper attendance to prevention modules
• Strengths and Difficulties Questionnaire "unlikely" or "possible diagnoses"
• presence of mood and/or anxiety disorders

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• PROCARE-I (UP-A for indicated purposes)
This 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.
• Active control condition
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.

Locations

Country	Name	City	State
Spain	Universidad Miguel Hernandez	Elche	Alicante
Spain	University of Jaen	Jaén	Jaen
Spain	Universitat Rovira i Virgili	Tarragona

Sponsors (4)

Lead Sponsor	Collaborator
University of Jaén	Universidad Miguel Hernandez de Elche, University of Miami, University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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.2 — View Citation

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 — View Citation

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/a00 — View Citation

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. — View Citation

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 Pu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported anxiety and mood symptomatology	The study's primary outcome was self-reported anxiety and mood symptomatology as assessed by Revised Child Anxiety Depression Scale (RCADS-30). Total scores range from 0 to 90. Higher scores mean a worse outcome	Baseline to 7 months after start of interventions
Primary	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 7 months after start of interventions
Primary	Absence of emotional disorders	The study's primary outcome was absence of any emotional disorders over the long-term measured by the ADIS-5-C/P	Baseline to 7 months after start of interventions
Secondary	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 7 months after start of interventions
Secondary	Economic evaluations	Implementation service costs (training, program materials, provider salaries), costs to school system, and later health costs saved for preventing emotional problems that could narrow cumulative disparities in mental health and disadvantage later in life.	Baseline to 7 months after start of interventions
Secondary	Psychological flexibility	Psychological flexibility as assessed by Willingness and Action Measure for Children and Adolescents (WAM-C/A).; Total scores range from 0 to 56. Higher scores mean a better outcome.	Baseline to 7 months after start of interventions]
Secondary	Emotional regulation	The Difficulties in Emotion Regulation Scale (DERS)	Baseline to 7 months after start of interventions]