Unified Protocol for Children: A Randomized Controlled Trial for the Portuguese Population

NCT04932421 | Completed

• 1 other identifier: Univeristy of Coimbra
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• Changes of children's anxiety and depression

  Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

• Changes of children's severity of psychopathology and improvement

  Measured with an adaptation of Clinical Global Impression (CGI). The CGI is composed by a severity of illness scale and a scale evaluating changes from the initiation of treatment. Higher scores are indicative of higher severity of psychopathology and lower improvement from the initiation of treatment.

  Baseline, Póst treatment (15 weeks)

Secondary Outcomes (17)

• Changes of child anxiety life interference

  Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

• Changes of children's psychological flexibility

  Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

• Changes of children's behavioral avoidance

  Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

• Changes of children's negative affect

  Baseline, Mid-treatment (7 weeks), Póst-treatment (15 weeks), Follow-up 3 months

• Changes of children's negative emotionality

  Baseline, Póst-treatment (15 weeks)

Other Outcomes (2)

• Feasibility of the program by adherence and dropout rate

  Póst-treatment (15 weeks)

• Acceptability of the program

  Póst-treatment (15 weeks)

Study Arms (2)

Experimental group (UP-C intervention)

EXPERIMENTAL

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

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

Control group (ABC of emotions intervention)

ACTIVE COMPARATOR

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

Other: ABC of Emotions

Interventions

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

UP-C is a transdiagnostic and emotion-focused cognitive-behavioral group intervention for children aged 6-13 years old with emotions disorders (i.e., anxious and/or mood disorders) and their parents. UP-C unifies cognitive-behavioral, contextual (eg. mindfulness) and parental training techniques aiming to reduce the intensity and frequency of children's clinical symptomatology. The intervention consists of 15 weekly group sessions (90 minutes per session; 5-8 children and parents per group) conducted by at least two clinical psychologists trained in the UP-C. The sessions start with the parents and children together (15 minutes); then, one psychologist conduct the session with the group of children while the other psychologist conduct the session with the group of parents, simultaneously (60 minutes); finally, the session ends with the group together (15 minutes). This is a structured and manualized intervention with a manual for the therapist and a workbook for the child and parents.

Also known as: UP-C

Experimental group (UP-C intervention)

ABC of Emotions OTHER

ABC of Emotions is a psychoeducational group intervention for children with anxiety and/or mood disorders, aged between 6 to 13 years. ABC of Emotions consists of 5 group psychoeducation sessions (about 90 minutes per session; 5-8 children per group). This is a structured and manualized intervention, with a manual for the therapist and a workbook for the child. The contents of the sessions were developed by the researchers of this study and are based on classic psychoeducational cognitive-behavioral therapies (CBT) strategies. Since anxiety disorders are more frequent in childhood than mood disorders (e.g., Merikangas et al., 2009), this program is essentially based on psychoeducation materials focused on emotions such as anxiety and fear. However, the same materials are available in an attachment, adapted for use with children to whom the main emotion is not fear/anxiety, but sadness (as in mood disorders).

Control group (ABC of emotions intervention)

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Centro Hospitalar Tondela-Viseu: collaborator

Study Sites (1)

Faculty of Psychology and Education Sciences, University of Coimbra

Coimbra, Coimbra, Portugal, 300-115, Portugal

Location

Related Publications (1)

• 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.

  PMID: 35162806 RESULT

Related Links

• Project webiste
• Project facebook

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Brígida Caiado, MsC

  Faculty of Psychology and Education Sciences, University of Coimbra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-blind - the investigator is unaware of the intervention assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra. , PhD student

Model Details: 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").

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 21, 2021
• Study Start: March 1, 2021
• Primary Completion: August 30, 2022
• Study Completion: November 30, 2022
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)