Clinical trial NCT04932421: Unified Protocol for Children: A Randomized Controlled Trial for the Portuguese Population
Official title: Emotion Detectives - Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children: A Randomized Controlled Trial in the Portuguese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Mood Disorders
Emotional Disorder
Emotional; Disorder, Childhood, With Anxiety and Fearfulness
Child Mental Disorder
Parenting
Keywords: emotional disorders
anxiety and mood disorders
children
parenting
transdiagnostic
unified protocol
randomized controlled trial
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Centro Hospitalar Tondela-Viseu
First posted: 2021-06-21
Enrollment: 153
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. experimental group (i.e., children and parents who benefit from the UP-C program).
2. control group (i.e., children who benefit from a psychoeducational intervention program, named "ABC of Emotions").
Primary purpose: TREATMENT

Brief summary: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) is a transdiagnostic and emotion-focused cognitive-behavioral group intervention for children aged 6-12 years old with emotion disorders (i.e., anxious and/or mood disorders) and their parents.

UP-C consists of 15 weekly group sessions and unifies cognitive-behavioral, contextual (e.g., mindfulness) and parental training techniques, for parents and children, aimed at reducing the intensity and frequency of strong and aversive emotional experiences in children and their clinical symptomatology.

The present study aims to assess the feasibility, acceptability and efficacy of the UP-C in the Portuguese population in reducing children's anxiety/depression symptoms. It also aims to investigate which mechanisms explain the therapeutic change.

Participants will be recruited at child mental health services and schools from Central Portugal and also through online dissemination of the study.

A randomized controlled trial (RCT) will be conducted in a sample of children aged 6-13 years old with emotional disorders and their parents in order to answer the critical question of whether the UP-C is more efficacious in reducing children's symptomatology than a psychoeducational group intervention (active control group).

Once the eligibility criteria are met (assessed by the project researchers) parents and children will be randomly assigned to one of two study conditions:

1. experimental group (i.e., children and parents who benefit from the UP-C program).
2. control group (i.e., children who benefit from a psychoeducational intervention program, named "ABC of Emotions").

Parents and children from both groups will complete several psychometrically robust and developmentally appropriate measures at baseline (T0), mid-treatment (only at week 7 of the UP-C; T1), post treatment (T2) and at 3 months follow-up (T3).


Eligibility criteria: Inclusion Criteria:

* Children aged 6-13
* Primary diagnosis of an anxiety and/or depression disorder
* Speaking, reading and understanding Portuguese

Exclusion Criteria:

* Diagnosis of a psychotic disorder, bipolar disorder or intellectual disability;
* Severe current suicidal/homicidal 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.

Primary outcomes:
measure: Changes of children's anxiety and depression
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of children's severity of psychopathology and improvement
timeFrame: Baseline, Póst treatment (15 weeks)
Secondary outcomes:
measure: Changes of child anxiety life interference
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of children's psychological flexibility
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of children's behavioral avoidance
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of children's negative affect
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of children's negative emotionality
timeFrame: Baseline, Póst-treatment (15 weeks)
measure: Changes of children's anxiety sensitivity
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of children's tolerance of negative emotions
timeFrame: Baseline, Mid-treatment (7 weeks), Póst treatment (15 weeks), Follow-up 3 months
measure: Changes of children's mindfulness skills
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of children's negative cognitive error
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of children's emotional expression and emotion awareness
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of parent's anxiety and depression
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks)
measure: Changes of parental anxiety, parental overprotection and parental support of children's coping behaviors
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of parental neuroticism
timeFrame: Baseline, Póst-treatment (15 weeks)
measure: Changes of parental inconsistency and permissiveness
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of parental criticism
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of shaping of negative emotions
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
measure: Changes of mindfulness in parenting
timeFrame: Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months
Other outcomes:
measure: Feasibility of the program by adherence and dropout rate
timeFrame: Póst-treatment (15 weeks)
measure: Acceptability of the program
timeFrame: Póst-treatment (15 weeks)
Locations:
city: Coimbra
country: Portugal
facility: Faculty of Psychology and Education Sciences, University of Coimbra
state: Coimbra, Portugal
Study officials:
affiliation: Faculty of Psychology and Education Sciences, University of Coimbra
name: Brígida Caiado, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caiado B, Gois A, Pereira B, Canavarro MC, Moreira H. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in Portugal: Feasibility Study Results. Int J Environ Res Public Health. 2022 Feb 4;19(3):1782. doi: 10.3390/ijerph19031782.