- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05664698
Emotion Regulation Training for Adolescents With ADHD
June 19, 2023 updated by: Uppsala University
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Johan Isaksson, PhD
- Phone Number: +46 018 6112540
- Email: johan.isaksson@neuro.uu.se
Study Contact Backup
- Name: Rebecka Astenvald, MSc
- Email: rebecka.astenvald@neuro.uu.se
Study Locations
-
-
-
Uppsala, Sweden
- Recruiting
- Uppsala University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SKILLS-ER
Emotion regulation training
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in self-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Time Frame: Changes in DERS-SF will be investigated with weekly ratings (i.e., one time per week): before (during 5, 6 or 7 weeks depending on length of baseline), during the intervention (8 ratings during 8 weeks) and after (2 ratings during 2 weeks) SKILLS-ER
|
Brief version of the Difficulties in Emotion Regulation Scale, consisting of 18 items.
Main outcomes include the total summed score of the DERS-SF, as well as the summed scores of individual subscales of the DERS-SF (six in total).
Items are rated on a scale of 1 (= almost never) to 5 (= almost always).
Items for the emotional awareness subscale are reverse-scored.
Higher scores indicate higher levels of emotion regulation difficulties.
|
Changes in DERS-SF will be investigated with weekly ratings (i.e., one time per week): before (during 5, 6 or 7 weeks depending on length of baseline), during the intervention (8 ratings during 8 weeks) and after (2 ratings during 2 weeks) SKILLS-ER
|
Changes in parent-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Time Frame: Changes in DERS-SF will be investigated with weekly ratings (i.e., one time per week): before (during 5, 6 or 7 weeks depending on length of baseline), during the intervention (8 ratings during 8 weeks) and after (2 ratings during 2 weeks) SKILLS-ER
|
Brief version of the Difficulties in Emotion Regulation Scale, consisting of 18 items.
Main outcomes include the total summed score of the DERS-SF, as well as the summed scores of individual subscales of the DERS-SF (six in total).
Items are rated on a scale of 1 (= almost never) to 5 (= almost always).
Items for the emotional awareness subscale are reverse-scored.
Higher scores indicate higher levels of emotion regulation difficulties.
|
Changes in DERS-SF will be investigated with weekly ratings (i.e., one time per week): before (during 5, 6 or 7 weeks depending on length of baseline), during the intervention (8 ratings during 8 weeks) and after (2 ratings during 2 weeks) SKILLS-ER
|
Changes in parental rated Target behaviors (individually defined) across baseline, intervention and post-intervention
Time Frame: Changes in target behaviors will be investigated with daily ratings: before (1 time per day during 5, 6 or 7 days before first week of intervention phase), during the intervention (1 time per day during 8 weeks) and after (daily during 2 weeks) SKILLS-ER
|
Individually defined target behaviors associated with emotion regulation which are rated in frequency.
|
Changes in target behaviors will be investigated with daily ratings: before (1 time per day during 5, 6 or 7 days before first week of intervention phase), during the intervention (1 time per day during 8 weeks) and after (daily during 2 weeks) SKILLS-ER
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in self-ratings with Cognitive Emotion Regulation Questionnaire from baseline to post-intervention
Time Frame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Cognitive Emotion Regulation Questionnaire (rated by participants only), which aims to measure different cognitive emotion regulation strategies (nine in total) and consists of 18 items.
Items are rated on a scale from 1 (= almost never) to 5 (= almost always).
Items belonging to a particular strategy are summed together, where higher scores indicate more usage of that specific strategy.
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Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Changes in self-ratings regarding functional impairment from baseline to post-intervention
Time Frame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Questionnaire on functional impairment in every-day life.
Scored with 4 items on a 5-point Likert scale with higher score indicating more functional impairment.
|
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Changes in parent-ratings regarding functional impairment from baseline to post-intervention
Time Frame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Questionnaire on functional impairment in every-day life.
Scored with 4 items on a 5-point Likert scale with higher score indicating more functional impairment.
|
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Changes in self-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention
Time Frame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Adult ADHD Self-Report Scale Adolescent version, consisting of 18 items in total.
Items are rated on a scale from 0 (=never) to 4 (=very often).
Items are summed together where higher scores indicate more ADHD symptoms.
|
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Changes in parent-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention
Time Frame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Adult ADHD Self-Report Scale Adolescent version, consisting of 18 items in total.
Items are rated on a scale from 0 (= never) to 4 (= very often).
Items are summed together, where higher scores indicate more ADHD symptoms.
|
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Changes in self-ratings with Spence Children's Anxiety Scale Short version (SCAS-S) from baseline to post-intervention
Time Frame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Spence Children's Anxiety Scale Short version (SCAS-S), consisting of 19 items in total.
Items are rated on a scale from 0 (= never) to 3 (= always).
The total score is the sum of all the items, where higher scores indicate more anxiety symptoms.
|
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Changes in parent-ratings with Spence Children's Anxiety Scale (SCAS) from baseline to post-intervention
Time Frame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Spence Children's Anxiety Scale.
Items are rated on a scale from 0 (= never) to 3 (= always).
The total score is the sum of all the 39 items, where higher scores indicate more anxiety symptoms.
|
Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Changes in parent-ratings with SNAP-IV from baseline to post-intervention
Time Frame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
The sum of the eight items on the SNAP-IV scale that measures symptoms of oppositional defiant disorder (rated by parents only).
Items are rated on a scale from 0 (= not at all) to 3 (= very much), with a higher score indication more symptoms.
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Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
|
Self-ratings with Negative Effects Questionnaire (NEQ)
Time Frame: Rated at 1 time-point directly after completing the last SKILLS-ER session
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Negative Effects Questionnaire.
Consists of 20 items.
A higher score indicates more negative effects.
|
Rated at 1 time-point directly after completing the last SKILLS-ER session
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Parent-ratings with Negative Effects Questionnaire (NEQ)
Time Frame: Rated at 1 time-point directly after completing the last SKILLS-ER session
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Negative Effects Questionnaire.
Consists of 20 items.
A higher score indicates more negative effects.
|
Rated at 1 time-point directly after completing the last SKILLS-ER session
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Self-rated Client satisfaction
Time Frame: Rated at 1 time-point directly after completing the last SKILLS-ER session
|
Items on client satisfaction.
In total 8 questions.
On 4 of these questions, items are rated on a 4-point Likert scale where higher score indicated a higher satisfaction with the intervention.
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Rated at 1 time-point directly after completing the last SKILLS-ER session
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Parent-rated Client satisfaction
Time Frame: Rated at 1 time-point directly after completing the last SKILLS-ER session
|
Items on client satisfaction.
In total 8 questions.
On 4 of these questions, items are rated on a 4-point Likert scale where higher score indicated a higher satisfaction with the intervention.
|
Rated at 1 time-point directly after completing the last SKILLS-ER session
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to treatment programme (ratings by therapists)
Time Frame: During intervention phase (directly after each session)
|
Therapist adherence to the treatment programme will be measured by the therapist self-ratings for each session.
Items are rated on a scale from 1 (=not completed) to 3 (=completed).
A higher score indicate better adherence.
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During intervention phase (directly after each session)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Johan Isaksson, PhD, Uppsala University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2023
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
November 24, 2022
First Submitted That Met QC Criteria
December 21, 2022
First Posted (Actual)
December 27, 2022
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 19, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ER_Isaksson
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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