Emotion Detectives In-Out: Feasibility and Efficacy of a Blended Version of the Unified Protocol for Children

Summary

The goal of this clinical trial is to test the efficacy of a blended format (i.e., a combination of face-to-face and online sessions into one integrated treatment protocol) of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in a sample of children aged between 7 and 12 years with a primary diagnosis of an anxiety disorder or with clinically significant levels of anxiety.

The main questions it aims to answer are:

* Is the proposed intervention (named Emotion Detectives In-Out) feasible and acceptable among Portuguese children with anxiety disorders and their parents?
* Is the Emotion Detectives In-Out intervention as effective as an evidence-based intervention for children's anxiety disorders in reducing anxiety symptomatology and changing secondary outcomes?
* What are the key predictors of adherence to the Emotion Detectives In-Out intervention?
* What are the key predictors of treatment outcomes?

Participants (children and one parent/legal representative) will:

* Participate in an initial interview with a clinical psychologist, who will assess if children and parents meet eligibility criteria.
* Complete an assessment protocol before, during, and after the intervention, as well as three months later.
* Be randomly assigned to one of the two conditions: experimental (Emotion Detectives In-Out) or active control (Coping Cat).
* Participate in one of the two psychological interventions. Researchers will compare the experimental and control groups to see if the Emotion Detectives In-Out intervention is equally efficacious as the Coping Cat intervention.

Conditions

• Anxiety Disorders

Interventions

BEHAVIORAL

Emotion Detectives In-Out

Emotion Detectives In-Out is a blended cognitive-behavioral intervention for children with emotional disorders aged between 7 to 12 years and their parents. It contains group sessions, online self-guided sessions and videoconference sessions. The groups will consist of about 5 to 7 children. Face-to-face sessions have an expected duration of 90 minutes and will be implemented by clinical psychologists with specific training in the program. The online sessions were developed by the research team and are completely self-guided. These sessions last approximately 45 minutes. Parents will be asked to participate in 2 face-to-face sessions, 4 videoconference sessions and 10 self-guided online sessions. It is a transdiagnostic and emotion-focused manualized cognitive-behavioral therapy designed to help children reduce the intensity and frequency of strong and aversive emotional experiences and to help parents reduce parental emotional behaviors.

BEHAVIORAL

Coping Cat

Coping Cat is a cognitive behavioral therapy for children with anxiety aged between 7 to 13 years. Coping Cat consists of 16 weekly group sessions with the children (5 to 7 children per group) and 2 sessions with the parents. Face-to-face sessions have an expected duration of 90 minutes and will be implemented by clinical psychologists.

Sponsors & Collaborators

• Fundação para a Ciência e a Tecnologia

  collaborator OTHER

• University of Lisbon

  collaborator OTHER

• University of Coimbra

  lead OTHER

Principal Investigators

• Helena Moreira, PhD · University of Coimbra

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-30

Primary Completion

2024-07-31

Completion

2024-12-31

Countries

• Portugal

Study Locations