Attention Deficit Disorder With HyperactivityNCT05664698
Emotion Regulation Training for Adolescents With ADHD
A study testing SKILLS-ER in people with Attention Deficit Disorder With Hyperactivity and Emotion Regulation, run by Uppsala University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Emotion Regulation, ADHD
- What is being tested?
- SKILLS-ER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 24 Jan 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ADHD diagnosis
- Self- and/or parent-rated emotion regulation difficulties, as indicated via the Emotion Questionnaire (EQ).
Who cannot join
- Intellectual disability
- Autism
- Psychosis
- Bipolar disorder
- Severe depression
- Non-stabilized medication for ADHD at intake (if on medication for ADHD)
- Other ongoing psychological treatment
Trial locations and contacts
1 site in 1 country.
Rebecka Astenvald, MSc contact
About this study
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.
Read the 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.
- Being tested
- SKILLS-ER
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKILLS-ERBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SKILLS-ER | Experimental | Emotion regulation training Receives: Behavioral: SKILLS-ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
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.
Measured: 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)
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.
Measured: 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
Individually defined target behaviors associated with emotion regulation which are rated in frequency.
Measured: 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 outcomes (12)
Changes in self-ratings with Cognitive Emotion Regulation Questionnaire from baseline to post-intervention
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Negative Effects Questionnaire. Consists of 20 items. A higher score indicates more negative effects.
Measured: Rated at 1 time-point directly after completing the last SKILLS-ER session
Parent-ratings with Negative Effects Questionnaire (NEQ)
Negative Effects Questionnaire. Consists of 20 items. A higher score indicates more negative effects.
Measured: Rated at 1 time-point directly after completing the last SKILLS-ER session
Self-rated Client satisfaction
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.
Measured: Rated at 1 time-point directly after completing the last SKILLS-ER session
Parent-rated Client satisfaction
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.
Measured: Rated at 1 time-point directly after completing the last SKILLS-ER session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start24 Jan 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One intervention (emotion regulation training) with three randomized pre-intervention baselines at different lengths.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Isaksson, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664698
- Sponsor's protocol ID
- ER_Isaksson
- Status last verified
- Jun 2023
- First submitted
- 24 Nov 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25581242
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Training for Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT05664698
- Acronym / sponsor ID
- ER_Isaksson
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One intervention (emotion regulation training) with three randomized pre-intervention baselines at different lengths.
| Arm | Type | Receives |
|---|---|---|
| SKILLS-ER | Experimental | Behavioral: SKILLS-EREmotion regulation training |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ADHD diagnosis
- Self- and/or parent-rated emotion regulation difficulties, as indicated via the Emotion Questionnaire (EQ).
Key exclusion criteria (7 listed)
- Intellectual disability
- Autism
- Psychosis
- Bipolar disorder
- Severe depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKILLS-ERThe 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. | Behavioural | SKILLS-ER |
Primary outcome
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 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 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.
12 secondary outcomes
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
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
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
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
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
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
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
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
Self-ratings with Negative Effects Questionnaire (NEQ)
Time frame: Rated at 1 time-point directly after completing the last SKILLS-ER session
Parent-ratings with Negative Effects Questionnaire (NEQ)
Time frame: Rated at 1 time-point directly after completing the last SKILLS-ER session
Self-rated Client satisfaction
Time frame: Rated at 1 time-point directly after completing the last SKILLS-ER session
Parent-rated Client satisfaction
Time frame: Rated at 1 time-point directly after completing the last SKILLS-ER session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 25581242Sheppes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecka Astenvald, MSc contact
Johan Isaksson, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKILLS-ER in people with Attention Deficit Disorder With Hyperactivity and Emotion Regulation, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Isaksson, PhD (+46 018 6112540, johan.isaksson@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05664698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.