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

NCT ID: NCT05747131

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

Childhood emotional disorders, particularly anxiety disorders, are an important public health concern due to their high and increasing prevalence, impact on children's functioning in multiple domains (e.g., family, academic, social), and long-term consequences. However, there is a significant gap between their needs and access to mental healthcare, with most children lacking access to evidence-based treatments (EBT). Several factors can contribute to a lack of adequate mental health care for children, including an insufficient number of trained clinicians, the difficulty of effectively disseminating the multitude of disorder-specific EBTs for emotional disorders to clinicians, and other barriers to face-to-face treatment. An Internet-based intervention can be an effective solution to overcome these difficulties. This project aims to develop and test the efficacy of a blended intervention of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C).

The UP-C is a cognitive-behavioral therapy (CBT) that takes a transdiagnostic approach to treating multiple emotional disorders simultaneously by addressing shared mechanisms underlying these disorders and employing a common set of EBT strategies (e.g., exposure, mindfulness). It is a child-friendly extension of the adult UP that delivers the UP core components in an interactive and child-friendly group format with extensive parent involvement. It has 15 weekly sessions for children and 15 weekly sessions for parents with an approximate duration of 90 minutes each. With a blended approach the researchers aim to improve the delivery of UP-C, by retaining the benefits of face-to-face and online therapy, while mitigating their limitations. This new version is expected to reduce costs of the therapy for families and institutions while also increasing compliance, motivation, uptake of treatment principles, and facilitating generalization of the application of core treatment components.

The blended version of the UP-C, named "Emotion Detectives In-Out" consists of 15 weekly sessions with the children (9 face-to-face group sessions, 4 online self-guided sessions and 2 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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Emotion Detectives In-Out

Emotion Detectives In-Out consists of 15 weekly sessions with the children (9 face-to-face group sessions, 4 online sessions and 2 videoconference sessions).

Group Type: EXPERIMENTAL

Emotion Detectives In-Out

Intervention Type: BEHAVIORAL

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.

Coping Cat

Coping Cat consists of 16 weekly group sessions with the children (5 to 7 children per group) and 2 sessions with the parents.

Group Type: ACTIVE_COMPARATOR

Coping Cat

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. The child is aged between 7 and 12 years;

2. The child has a primary diagnosis of an anxiety disorder or clinically significant anxiety symptoms;

3. Both the child and the parent are able to speak, read and understand Portuguese;

4. Both the child and the parent have Internet access.

Exclusion Criteria

1. Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability or autism spectrum disorder;

2. Severe current suicidal ideation;

3. The child is not on a stable dose of a psychotropic or other type of medication for at least 1 month prior to T0 assessment;

4. The child has previously received CBT with exposure techniques.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role: collaborator

University of Lisbon

OTHER

Sponsor Role: collaborator

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Helena Moreira

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Moreira, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Coimbra

Locations

Faculty of Psychology and Educational Sciences

Coimbra, , Portugal

Faculty of Psychology, University of Lisbon

Lisbon, , Portugal

Countries

Portugal

Central Contacts

Helena Moreira, PhD

Role: CONTACT

helena.tcmoreira@gmail.com

00351918811714

Ana Isabel Pereira, PhD

Role: CONTACT

aipereira@psicologia.ulisboa.pt

Facility Contacts

Ana Isabel Pereira, PhD

Role: primary

References

Moreira H, Skvarc D, Gomes-Pereira B, Albuquerque A, Gois AC, Fonseca A, Pereira AM, Caiado B, Paulino B, Santos C, Ehrenreich-May J, Canavarro MC, Saraiva M, Vicente VN, Pereira AI. Study protocol for a randomized controlled trial testing the efficacy of Emotion Detectives In-Out: a blended version of the unified protocol for transdiagnostic treatment of emotional disorders in Portuguese children. BMC Psychol. 2024 Feb 7;12(1):63. doi: 10.1186/s40359-024-01532-z.

Reference Type: DERIVED

PMID: 38326847 (View on PubMed)

Other Identifiers

PTDC/PSI-GER/0689/2020

Identifier Type: -

Identifier Source: org_study_id