Unified Protocol for Children: A Randomized Controlled Trial for the Portuguese Population (UP-C)

University of Coimbra

Status: Completed

Conditions: Emotional Disorder; Parenting; Mood Disorders; Anxiety Disorders; Emotional; Disorder, Childhood, With Anxiety and Fearfulness; Child Mental Disorder

Treatments: Behavioral: Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C); Other: ABC of Emotions

Study type: Interventional

Funder types: Other

Identifiers

NCT04932421

Univeristy of Coimbra

Details and patient eligibility

About

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).

Enrollment: 153 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 2 patient groups

Experimental group (UP-C intervention)

Experimental group

Description:

UP-C intervention 15 weekly sessions, for children and parents

Treatment:

Behavioral: Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C)

Control group (ABC of emotions intervention)

Active Comparator group

Description:

ABC of emotions - a psychoeducational intervention 5 sessions every 3 weeks for children

Treatment:

Other: ABC of Emotions