Efficacy Study of a Child-centered Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children

NCT05798299 | Unknown

• 1 other identifier: 2020.06835.BD
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The UP-C is a manualized, cognitive-behavioral, and emotion-focused group intervention with a transdiagnostic approach aimed at the treatment of emotional problems (i.e., anxiety and depression) in children aged 7 to 12 years old. This psychological intervention mainly focuses on reducing the intensity and frequency of strong and aversive emotional experiences in children through the development of skills that allow them to face these emotions in a more adaptive way. By targeting the factors common to emotional disorders (avoidance, emotional reactivity, affective intolerance) we believe this intervention might increase the effectiveness of the treatment of these difficulties (mainly in the cases where comorbidity is present). It may also contribute to therapists' expertise when dealing with different emotional disorders, by not requiring the simultaneous mastery of multiple interventions, to a reduction of costs associated with training and to the planning of more individualized and flexible interventions. This approach could help to make interventions suitable for a set of problems more accessible to the public - which is particularly relevant to the Portuguese context. Thus, to better adapt to the limitations existent in mental health services in Portugal, a modified version of the UP-C was developed by reducing the number of sessions for parents. The current study seeks to understand whether this adapted version of the UP-C - the UP-C/C - less demanding in terms of resources required for its application, is effective in reducing children's emotional symptomatology and produces changes on maladaptive parenting strategies used by parents. This version is mostly centered on the child, who participates in 15, 90 minutes, group sessions. In this version of the program, the parents adopt the role of "cotherapists", and support homework completion at home by the child. They also have access to psychoeducational material (in video and written format). Additionally, the UP-C/C includes three parental sessions that focus on parenting strategies shown to be useful in challenging situations. This study also seeks to evaluate child and parent involvement in the intervention and understand its predictors. These are the specific objectives of the study:

1. 1.To evaluate the efficacy of the UP-C/C through a Randomized Controlled Clinical Trial with two conditions (UP-C/C and Coping Cat in group format) on the primary outcomes (child's anxiety and depression symptoms, interference of anxiety and depression in the child's school, social and family functioning), secondary (quality of life, emotional expression and cognitive errors), and on the transdiagnostic factors (avoidance, emotional reactivity, affective intolerance) and on the parental variables (parents' emotional behaviors, orientation towards the child's emotions, symptoms of anxiety and depression);
2. 2.To evaluate the involvement of the child and parents in the program (attendance, dropout, active participation) and find out its predictors (age; intensity of symptoms; readiness for change; therapeutic alliance; expectations regarding the intervention).

Conditions

Emotional Disorders; Childhood Anxiety; Childhood Depression

Keywords

Randomized controlled trial; Anxiety Disorders; Mood disorders; Transdiagnostic Intervention; UP-C; UP-C/C; Parenting

Outcome Measures

Primary Outcomes (3)

• Changes in the children's anxiety and depression

  Measured with the Revised Children's Anxiety and Depression Scale (RCADS) (Child and Parent Version) Child version: Self-report questionnaire composed by 47 items and 6 subscales, including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and major depression. It also includes a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Parent version: Measure completed by the parents that includes 6 subscales to assess the child's anxiety and depression symptoms.

  Recruitment/Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)

• Changes in the children's severity of psychopathology and improvement

  Measured with an adaptation of the Clinical Global Impression (CGI). Brief assessment of the patient's global functioning before and after the intervention, the CGI is composed by an illness' severity scale and a scale evaluating changes in the patient's symptoms relative to their condition at the start of the intervention. Higher scores are indicative of higher severity of psychopathology.

  Baseline, Mid-treatment (6 weeks); Post treatment (15 weeks)

• Changes in the child's anxiety life interference

  Measured with the Child Anxiety Life Interference Scale (Child and Parent Versions) Child version: Questionnaire for evaluating the influence of the child's symptoms on their school, social and family functioning. Parent version: Measure for assessing the influence of the child's symptoms on their school, social and family functioning through parental report.

  Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)

Secondary Outcomes (12)

• Changes in the children's behavioral avoidance

  Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)

• Changes in the children's negative affect

  Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)

• Changes in the children's anxiety sensitivity

  Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)

• Changes in the children's cognitive distortions

  Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)

• Changes in the children's emotional expression and emotion awareness

  Baseline, Mid-treatment (6 weeks), Post-treatment (15 weeks), Follow-up (3 and 6 months)

Other Outcomes (7)

• Changes in the Principal Problems

  Baseline; during the intervention (up to 16 weeks); post-intervention

• Parent's and children's evaluation of program materials

  During the intervention (up to 16 weeks)

• Motivation to change scale - parents and children

  Baseline; mid-intervention before exposure sessions

Study Arms (2)

UP-C/C

EXPERIMENTAL

UP-C/C intervention - 15 weekly sessions for children; 3 group sessions for parents; 1 family meeting before exposure sessions.

Behavioral: Arm 1: Transdiagnostic intervention

Coping Cat, Group Format

ACTIVE COMPARATOR

Coping Cat in group format intervention - 16 weekly sessions for children; 2 individual sessions for parents.

Behavioral: Arm 2: Anxiety-focused intervention

Interventions

Arm 1: Transdiagnostic intervention BEHAVIORAL

The UP-C/C consists of 15 weekly sessions for children, each lasting 90 minutes. It is also composed by three sessions for parents and a meeting with the family prior to the exposure sessions. Parents have access to weekly psychoeducational material (in written and in video format) and help the children with homework completion.

Also known as: UP-C/C, Unified Protocol for Children - Child-Centered Version, Emotion Detectives - Child-Centered Version

UP-C/C

Arm 2: Anxiety-focused intervention BEHAVIORAL

The Coping Cat in group format is a cognitive-behavioral evidence-based intervention for anxiety problems. It is composed by 16 90-minute sessions for children and two parenting sessions.

Coping Cat, Group Format

Eligibility Criteria

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

You may qualify if:

• Children aged 7-12;
• Children whose score in the screening of anxiety symptoms is in a percentile equal to or greater than 80;
• Speaking, reading and understanding Portuguese;

You may not qualify if:

• Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability or autism spectrum disorder;
• Severe current suicidal/homicidal ideation;
• The child is being subjected to a not yet stable dose of a psychotropic or other type of medication (i.e., modified less than 1 month prior to baseline assessment);
• The child or parents are not fluent in the Portuguese language;
• The child is benefiting from another psychological intervention;
• Presence of the parents and the child cannot be guaranteed in most of the intervention and assessment sessions; the presence of the parents is only required in the parenting sessions and in the evaluation sessions (week 6, after the intervention, and two follow-ups).

Sponsors & Collaborators

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

Study Sites (1)

Faculty of Psychology, University of Lisbon

Lisbon, 1649-013, Portugal

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Ana Maria R Pereira, MsC

CONTACT

912769592; ana.maria.pereira@edu.ulisboa.pt

Ana Isabel F Pereira, PhD

CONTACT

217943636; 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: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 4, 2023
• Study Start: March 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)