First Evaluation of COMET-Y (COMET-Y)

A Pilot Study: A First Evaluation of a Personalized Training Targeting Low Self-esteem: COMET-Y

The goal of this pilot study is to evaluate COMET-Y in 22 adolescents (11-18 years) with various mental health problems and low self-esteem. The main questions is: Does COMET-Y, parallel to care as usual (CAU), improve self-esteem?

Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Youth and therapists will be assessed to evaluate feasibility and acceptability of the COMET-Y training.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Self Esteem
• Intervention / Treatment: Behavioral: COMET-Y

Detailed Description

Low self-esteem plays an important role in various mental health problems, and targeted treatment of self-esteem could potentially enhance the efficacy of existing treatments. Research in adults shows that self-esteem training improves self-esteem and mental health problems, but in adolescents this is still unknown. COMET-Y is a personalized self-esteem training, specifically developed for adolescents.

In this pilot study, 22 adolescents (11-18 years) with various mental health problems and low self-esteem will be included. Participants receive COMET-Y parallel to care as usual (CAU). Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Feasibility and acceptability of the COMET-Y training will be evaluated with youth and therapists.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rianne Hornstra, PhD.; Phone Number: (050) 368 11 00; Email: r.hornstra@accare.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• sufficient mastery of Dutch to complete the measurements
• age between 11 - 18 years
• having self-esteem below average (based on a score =<15 on the Rosenberg Self-esteem Scale; RSES)
• currently receiving care for a mental disorder, for example (but not limited to) anxiety disorder, depression, eating disorder, attention-deficit/hyperactivity disorder, oppositional defiant disorder, or autism spectrum disorder.
• willingness to participate in weekly sessions

Exclusion Criteria:

• As intensive treatment can restrain the feasibility of attending the 7 weekly sessions of COMET-Y and engage in homework assignments, participants who need acute care are excluded (e.g. crisis, acute suicidality, or psychotic episode).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: COMET-Y; All participants receive COMET-Y.

Behavioral: COMET-Y; Competitive memory training (COMET) is a transdiagnostic intervention first developed for adults and later adapted to be used in children and adolescents. The adapted version for youth consists of 7 sessions in which participants learn to facilitate activation of functional/positive thoughts instead of relying on dysfunctional/negative thoughts by using positive self-verbalizations, imagery, body posture, and music. In addition, they are challenged to reformulate dysfunctional/negative thoughts into more functional/positive thoughts. As an addition to the original COMET protocol, there is a parent session in which parents receive psycho-education about their influence on self-esteem. Parents learn to be a 'co-therapist' and to support practicing at home and improve generalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Esteem	Global self esteem measured with the Rosenberg self-esteem scale (RSES). Range: 0-30, higher score means higher self-esteem.	Two weeks before COMET-Y and a week after COMET-Y

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Domain-specific Self Esteem	Domain-specific self esteem measured with the Competentiebelevingsschaal voor adolescenten (CBSA). Range: 5-20 for each subscale, a higher score means more competence for the specific domains.	Two weeks before COMET-Y and a week after COMET-Y
Mental Health Problems	Mental health problems measured with the Strengths and Difficulties Questionnaire (SDQ). Range total score: 0-40, with a higher score corresponding to more problems.	Two weeks before COMET-Y and a week after COMET-Y
Quality of life	Quality of life measured with the Kidscreen-27. Range: 0-130, a higher score means a higher quality of life.	Two weeks before COMET-Y and a week after COMET-Y
Affect	Positive and negative affect, measured with the Positive and negative affects schedule. (PANAS-C). Range: 0-100, with a higher score higher affect (positive or negative).	Two weeks before COMET-Y and a week after COMET-Y
Resilience	Resilience is measured with the Brief Resilience Scale (BRS). Range: 1-5, a higher score indicates more resilience.	Two weeks before COMET-Y and a week after COMET-Y
Ecological Momentary Assessments - Global self-esteem	Global self-esteem: short-version of the Rosenberg Self-esteem Scale, as part of a short questionnaire filled in three times a day by the participants via their mobile phones. Range: 0-16, higher score means higher self-esteem.	Two weeks before and two weeks after COMET-Y
Ecological Momentary Assesments - Goal Based Outcome (GBO) tool for young people	The Goal-Based Outcome (GBO) tool for young people, as part of a short questionnaire filled in three times a day by the participants via their mobile phones. Participants fill in three personalized goals, which they rate on a scale from 1-10, where higher scores indicate improved goal progress.	Two weeks before and two weeks after COMET-Y
Ecological Momentary Assesments - Domain-specific self-esteem	Domain-specific self-esteem: perceived self-esteem related functioning covering the specific domains measured by the Competentiebelevingsschaal voor Adolescenten. Range: 0-60, where higher scores indicate more competence.	Two weeks before and two weeks after COMET-Y

Collaborators and Investigators

• Sponsor: Accare

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Quality of Life; Self Esteem; Mental Health Problems; Ecological Momentary Assesment
• Other Study ID Numbers: PSY-2324-S-0136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will ask permission to share the pseudonymized data for potential future re-analysis, such as in a individual participant meta-analysis.
• IPD Sharing Time Frame: Data can be requested after publication.
• IPD Sharing Access Criteria: A pseudonymised dataset and analysed dataset will be archived so that data can be shared or checked later (FAIR data use) if the participants have agreed to that.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No