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

NCT05747131 | Unknown

• 1 other identifier: PTDC/PSI-GER/0689/2020
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety Disorders

Keywords

Unified Protocol; Children; Blended therapy; Parents

Outcome Measures

Primary Outcomes (4)

• Change in anxiety symptoms as measured by the Revised Children's Anxiety and Depression Scale (RCADS).

  The Revised Children's Anxiety and Depression Scale is a 47 item self-report questionnaire that measures symptoms of depression and anxiety in children and adolescents aged 8 - 18. It has 6 subscales: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It yields a Total Anxiety Scale (the sum of the 5 anxiety subscales) and a Total Anxiety \& Depression Scale (sum of all 6 subscales). The Total Anxiety Scale ranges from 0 to 111, and the Total Anxiety \& Depression scale ranges from 0 to 141, with higher scores indicating increased symptom severity.

  Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up]

• Change in anxiety symptoms as measured by the Revised Children's Anxiety and Depression Scale - Parent version (RCADS-P).

  The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) is a 47 item parent-reported questionnaire that measures symptoms of depression and anxiety in children and adolescents aged 8 - 18. It has 6 subscales: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It yields a Total Anxiety Scale (the sum of the 5 anxiety subscales) and a Total Anxiety \& Depression Scale (sum of all 6 subscales). The Total Anxiety Scale ranges from 0 to 111, and the Total Anxiety \& Depression scale ranges from 0 to 141, with higher scores indicating increased symptom severity.

  Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up

• Change in anxiety symptoms as measured by the Clinician Global Impression - Improvement scale (CGC-I).

  Higher scores indicate increased symptom worsening.

  within 1 week post-treatment

• Change in severity of anxiety symptoms as measured by the Clinician Global Impression - Severity scale (CGC-S).

  The Clinician Global Impression - Severity scale is a one-item measure assessing the clinician's perception of the severity of the patient's symptoms, with scores ranging from 1 (not at all ill) to 7 (extremely ill). Higher scores indicate increased symptom severity.

  Baseline, within 1 week post-treatment

Secondary Outcomes (15)

• Change in the interference of anxiety in child's life, as measured by the Child Anxiety Life Interference Scale - Self-Report (CALIS-C)

  Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up

• Change in the interference of anxiety in child's life, as measured by the Child Anxiety Life Interference Scale - Parent's Report (CALIS-P)

  Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up

• Change in children's behavioral avoidance, as measured by the Child Avoidance Measure Self-Report (CAMS)

  Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up

• Change in children's behavioral avoidance, as measured by the Child Avoidance Measure Parent-Report (CAMP)

  Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up

• Change in children's positive and negative affect, as measured by the Positive and Negative Affect Schedule for Children - Short Version (PANAS-C-SF)

  Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up

Other Outcomes (9)

• Parents' motivation to participate in the intervention, as measured by the Motivation for Change Rating Scale - Parental Version (MCRS)

  Baseline

• Parents' self-efficacy and enjoyment in using the internet and technology

  Baseline

• Children's self-efficacy and enjoyment in using the internet and technology

  Baseline

Study Arms (2)

Emotion Detectives In-Out

EXPERIMENTAL

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).

Behavioral: Emotion Detectives In-Out

Coping Cat

ACTIVE COMPARATOR

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

Behavioral: Coping Cat

Interventions

Emotion Detectives In-Out 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.

Emotion Detectives In-Out

Coping Cat 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.

Coping Cat

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child is aged between 7 and 12 years;
• The child has a primary diagnosis of an anxiety disorder or clinically significant anxiety symptoms;
• Both the child and the parent are able to speak, read and understand Portuguese;
• Both the child and the parent have Internet access.

You may not qualify if:

• Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability or autism spectrum disorder;
• Severe current suicidal ideation;
• 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;
• The child has previously received CBT with exposure techniques.

Sponsors & Collaborators

• University of Coimbra: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• University of Lisbon: collaborator

Study Sites (2)

Faculty of Psychology and Educational Sciences

Coimbra, 3000-115, Portugal

Location

Faculty of Psychology, University of Lisbon

Lisbon, Portugal

Location

Related Publications (1)

• 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.

  PMID: 38326847 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Helena Moreira, PhD

  University of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Moreira, PhD

CONTACT

00351918811714; helena.tcmoreira@gmail.com

Ana Isabel Pereira, PhD

CONTACT

aipereira@psicologia.ulisboa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 28, 2023
• Study Start: September 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)