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

NCT05252026 | Completed DMC

• 1 other identifier: UJA-PROCARE-I
• Study Type: interventional
• Target: 68
• 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 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.

Conditions

Anxiety Disorders and Symptoms; Depressive Symptoms

Keywords

ADOLESCENCE; TRANSDIAGNOSTIC; indicated PREVENTION; Randomized-Controlled Trial; high-risk

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Health-related quality of life

  Baseline to 7 months after start of interventions

• Economic evaluations

  Baseline to 7 months after start of interventions

• Psychological flexibility

  Baseline to 7 months after start of interventions]

• Emotional regulation

  Baseline to 7 months after start of interventions]

Study Arms (2)

PROCARE-I (UP-A for indicated purposes)

EXPERIMENTAL

To ensure cost-effectiveness, PROCARE-I intervention will be designed as a brief 8-session child-focused programme 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 indicated preventive intervention format focused on cost-effectiveness.

Behavioral: PROCARE-I (UP-A for indicated purposes)

Active control condition

EXPERIMENTAL

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 one alternative compare condition to PROCARE-I. The U Talk programme support-based group condition will be used as active control condition.

Behavioral: Active control condition

Interventions

PROCARE-I (UP-A for indicated purposes) BEHAVIORAL

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.

PROCARE-I (UP-A for indicated 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
• 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

You may not qualify if:

• 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

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

• Luis-Joaquin Garcia-Lopez, Ph.D.

  University of Jaen

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: One intervention is evaluated in parallel against a active control group

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 23, 2022
• Study Start: September 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

ES (3)