Clinical trial NCT05664698: Emotion Regulation Training for Adolescents With ADHD
Official title: Emotion Regulation Training for Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Emotion Regulation
ADHD
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 6
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One intervention (emotion regulation training) with three randomized pre-intervention baselines at different lengths.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in self-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
timeFrame: 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
measure: Changes in parent-ratings across baseline, intervention, post-intervention with Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
timeFrame: 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
measure: Changes in parental rated Target behaviors (individually defined) across baseline, intervention and post-intervention
timeFrame: 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:
measure: Changes in self-ratings with Cognitive Emotion Regulation Questionnaire from baseline to post-intervention
timeFrame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
measure: Changes in self-ratings regarding functional impairment from baseline to post-intervention
timeFrame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
measure: Changes in parent-ratings regarding functional impairment from baseline to post-intervention
timeFrame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
measure: Changes in self-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention
timeFrame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
measure: Changes in parent-ratings with Adult ADHD Self-Report Scale Adolescent version (ASRS-A) from baseline to post-intervention
timeFrame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
measure: Changes in self-ratings with Spence Children's Anxiety Scale Short version (SCAS-S) from baseline to post-intervention
timeFrame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
measure: Changes in parent-ratings with Spence Children's Anxiety Scale (SCAS) from baseline to post-intervention
timeFrame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
measure: Changes in parent-ratings with SNAP-IV from baseline to post-intervention
timeFrame: Comparing ratings before and after intervention. 1 assessment 1 week before the baseline phase, and 1 assessment 2 weeks after the intervention SKILLS-ER
measure: Self-ratings with Negative Effects Questionnaire (NEQ)
timeFrame: Rated at 1 time-point directly after completing the last SKILLS-ER session
measure: Parent-ratings with Negative Effects Questionnaire (NEQ)
timeFrame: Rated at 1 time-point directly after completing the last SKILLS-ER session
measure: Self-rated Client satisfaction
timeFrame: Rated at 1 time-point directly after completing the last SKILLS-ER session
measure: Parent-rated Client satisfaction
timeFrame: Rated at 1 time-point directly after completing the last SKILLS-ER session
Other outcomes:
measure: Adherence to treatment programme (ratings by therapists)
timeFrame: During intervention phase (directly after each session)
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Johan Isaksson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.