Emotion Regulation Training for Adolescents With ADHD

NCT ID: NCT05664698

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-24

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this single-case study is to pilot and evaluate a new psychological intervention (SKILLS-ER) targeting emotion regulation in adolescents with ADHD. Participants (n=9; 13-18 years of age) and their parents will partake in the intervention consisting of a total of eight sessions.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Attention-Deficit/Hyperactivity Disorder (ADHD) results in functional impairment across several life domains and is associated with high comorbidity rates and negative long-term outcomes. For adolescents with ADHD, emotional dysregulation constitute an increasing health problem. The ability to regulate one's emotions has been suggested as a major candidate for transdiagnostic sources of risk and/or resilience. A sample of adolescents (n=9; 13-18 years of age) with ADHD and emotion dysregulation will participate in an emotion regulation intervention (SKILLS-ER) in order to evaluate feasibility, potential effectiveness and to detect mechanisms that could strengthen adaptive regulation skills. The emotion regulation programme will include eight weekly sessions, and although primarily directed towards the adolescent, parents will be invited and participate in some sessions. The researchers will apply a single-case multiple baseline design across participants with repeated measurements and pre-intervention baselines at different lengths (5, 6 and 7 weeks) to which participants are randomized. The researchers will analyze the data with a combination of visual and quantitative analyses, see study protocol and statistical analysis plan.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Disorder With Hyperactivity Emotion Regulation ADHD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

One intervention (emotion regulation training) with three randomized pre-intervention baselines at different lengths.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SKILLS-ER

Emotion regulation training

Group Type EXPERIMENTAL

SKILLS-ER

Intervention Type BEHAVIORAL

The intervention (SKILLS-ER) has been developed by the research group, and aims to increase a participant's emotion regulation capacity by targeting different stages of the emotion regulation process proposed by the extended process model of emotion, i.e. identification, selection, implementation and monitoring (Sheppes, Suri \& Gross, 2015). SKILLS-ER will comprise of eight sessions and include identification and differentiation of emotions, tolerance/acceptance of emotions, education of different regulatory skills, as well as on how to select, implement and monitor strategies. Sessions will take place at the Uppsala child- and adolescent psychiatry outpatient unit and consist of activating and experiential exercises administered by a clinical psychologist. Participants will gain access to internet-delivered material, such as homework assignments in-between sessions. SKILLS-ER will be delivered individually to the participants, where their parents will be involved in some sessions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SKILLS-ER

The intervention (SKILLS-ER) has been developed by the research group, and aims to increase a participant's emotion regulation capacity by targeting different stages of the emotion regulation process proposed by the extended process model of emotion, i.e. identification, selection, implementation and monitoring (Sheppes, Suri \& Gross, 2015). SKILLS-ER will comprise of eight sessions and include identification and differentiation of emotions, tolerance/acceptance of emotions, education of different regulatory skills, as well as on how to select, implement and monitor strategies. Sessions will take place at the Uppsala child- and adolescent psychiatry outpatient unit and consist of activating and experiential exercises administered by a clinical psychologist. Participants will gain access to internet-delivered material, such as homework assignments in-between sessions. SKILLS-ER will be delivered individually to the participants, where their parents will be involved in some sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ADHD diagnosis
* Self- and/or parent-rated emotion regulation difficulties, as indicated via the Emotion Questionnaire (EQ).

Exclusion Criteria

* Intellectual disability
* Autism
* Psychosis
* Bipolar disorder
* Severe depression
* Non-stabilized medication for ADHD at intake (if on medication for ADHD)
* Other ongoing psychological treatment
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johan Isaksson, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uppsala University

Uppsala, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Johan Isaksson, PhD

Role: CONTACT

+46 018 6112540

Rebecka Astenvald, MSc

Role: CONTACT

References

Explore related publications, articles, or registry entries linked to this study.

Sheppes G, Suri G, Gross JJ. Emotion regulation and psychopathology. Annu Rev Clin Psychol. 2015;11:379-405. doi: 10.1146/annurev-clinpsy-032814-112739. Epub 2015 Jan 2.

Reference Type BACKGROUND
PMID: 25581242 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ER_Isaksson

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.