Clinical trial NCT05747131: Emotion Detectives In-Out: Feasibility and Efficacy of a Blended Version of the Unified Protocol for Children
Official title: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children: A Multicenter Study to Assess the Acceptability, Feasibility and Efficacy of a Blended Format of the Program in Portugal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: Unified Protocol
Children
Blended therapy
Parents
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: University of Lisbon
First posted: 2023-02-28
Enrollment: 180
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in anxiety symptoms as measured by the Revised Children's Anxiety and Depression Scale (RCADS).
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up]
measure: Change in anxiety symptoms as measured by the Revised Children's Anxiety and Depression Scale - Parent version (RCADS-P).
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in anxiety symptoms as measured by the Clinician Global Impression - Improvement scale (CGC-I).
timeFrame: within 1 week post-treatment
measure: Change in severity of anxiety symptoms as measured by the Clinician Global Impression - Severity scale (CGC-S).
timeFrame: Baseline, within 1 week post-treatment
Secondary outcomes:
measure: Change in the interference of anxiety in child's life, as measured by the Child Anxiety Life Interference Scale - Self-Report (CALIS-C)
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in the interference of anxiety in child's life, as measured by the Child Anxiety Life Interference Scale - Parent's Report (CALIS-P)
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in children's behavioral avoidance, as measured by the Child Avoidance Measure Self-Report (CAMS)
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in children's behavioral avoidance, as measured by the Child Avoidance Measure Parent-Report (CAMP)
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in children's positive and negative affect, as measured by the Positive and Negative Affect Schedule for Children - Short Version (PANAS-C-SF)
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in children's anxiety sensitivity, as measured by the Children's Anxiety Sensitivity Inventory-Revised (CASI-R).
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in children's difficulties in emotion expression, as measured by the Emotional Expression Scale for Children (EESC)
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in children's negative cognitive errors, as measured by the Children's Negative Cognitive Error Questionnaire (CNCEQ)
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in children's quality of life, as measured by the KIDSCREEN-10 Index (Parent Report)
timeFrame: Baseline, Mid-treatment (week 7), within 1 week post-treatment, 3 months follow-up
measure: Change in parental overprotection, as measured by the Parental Anxiety and Overprotection Scale (PAOS)
timeFrame: Baseline, within 1 week post-treatment, 3 months follow-up
measure: Change in parental criticism as measured by the Egna Minnen Beträffande Uppfostran Scale (EMBU-P)
timeFrame: Baseline, within 1 week post-treatment, 3 months follow-up
measure: Change in parental modeling of intense emotions, as measured by the Parent Emotion Regulation Scale (PERS)
timeFrame: Baseline, within 1 week post-treatment, 3 months follow-up
measure: Change in parental inconsistency, as measured by the Parenting Inconsistency Scale
timeFrame: Baseline, within 1 week post-treatment, 3 months follow-up
measure: Change in parental depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9).
timeFrame: Baseline, within 1 week post-treatment, 3 months follow-up
measure: Change in parental anxiety symptoms, as measured by the General Anxiety Disorder-7 (GAD-7).
timeFrame: Baseline, within 1 week post-treatment, 3 months follow-up
Other outcomes:
measure: Parents' motivation to participate in the intervention, as measured by the Motivation for Change Rating Scale - Parental Version (MCRS)
timeFrame: Baseline
measure: Parents' self-efficacy and enjoyment in using the internet and technology
timeFrame: Baseline
measure: Children's self-efficacy and enjoyment in using the internet and technology
timeFrame: Baseline
measure: Parental beliefs about child anxiety, as measured by the Parental Beliefs About Child Anxiety Questionnaire (PBA-Q)
timeFrame: Baseline
measure: Parents' involvement in therapy, as measured by the Parental Involvement in Therapy Scale (PITS)
timeFrame: within 1 week post-treatment
measure: Feasibility of the intervention as measured by adherence
timeFrame: within 1 week post-treatment
measure: Feasibility of the intervention as measured by drop-out rates
timeFrame: within 1 week post-treatment
measure: Feasibility of the intervention as measured by the pattern of the online sessions usage
timeFrame: within 1 week post-treatment
measure: Acceptability of the intervention
timeFrame: within 1 week post-treatment
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Educational Sciences
city: Lisbon
country: Portugal
facility: Faculty of Psychology, University of Lisbon
Study officials:
affiliation: University of Coimbra
name: Helena Moreira, PhD
role: PRINCIPAL_INVESTIGATOR
References: