AdhdNCT03733548
Improving Emotion Regulation in Adolescents With ADHD
A study testing RELAX in people with Adhd, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
The purpose of our study is to examine the impact of a program that provides emotion regulation skills for adolescents aged 11-16 with Attention-Deficit/Hyperactivity Disorder (ADHD) and poor emotion regulation. The program is called RELAX (Regulating Emotions Like An eXpert). Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Adhd
- What is being tested?
- RELAX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2018to 27 Jun 2019
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD diagnosis
- parent-reported emotion regulation in the clinical range
- full scale intelligence quotient ≥80
- English as a primary language
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clark-Hill Institute for Positive Youth Development
Richmond, Virginia, 23284
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of our study is to examine the impact of a program that provides emotion regulation skills for adolescents aged 11-16 with Attention-Deficit/Hyperactivity Disorder (ADHD) and poor emotion regulation. The program is called RELAX (Regulating Emotions Like An eXpert). RELAX is an experimental intervention that may equip adolescents with emotion regulation and conflict management skills and includes parent involvement to help parents support adolescents' use of these skills.
Read the detailed description
Regulating Emotions Like An eXpert (RELAX) consists of 8 weekly 90-minute group sessions and 1 booster session 8 weeks after the completion of the RELAX intervention. The first 60 minutes of each group involve separate parent and adolescent groups. Adolescents (ages 11-16) attend an emotion regulation and conflict management skills group, while parents attend a group focused on how to support utilization of these skills in adolescents at home and school through use of modeling their own emotion regulation skills and use of supportive emotion socialization practices. For the final 30 minutes of the session, parents and adolescents combine and complete a collaborative activity and skill rehearsal homework is discussed for the week. Homework will be discussed at the beginning of the separate group meetings the following week. The primary overall goal of the RELAX intervention is to assist adolescents and parents in traveling down the Path of RELAXation by working on the three C's (communication, coping, and conflict management skills). A multimethod assessment of emotional, social, and family functioning will be assessed pre- and post-intervention and at an 8 week follow-up.
- Conditions
- Adhd
- Being tested
- RELAX
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELAXBehavioural
Regulating Emotions Like An eXpert (RELAX) consists of 8 weekly, 90-minute sessions delivered (60 minutes of parents and adolescents meeting separately, 30 minutes of a combined meeting) in a group format. RELAX equips adolescents with emotion regulation and conflict management skills. This program includes a parent involvement component designed to help parents support adolescents' use of these skills. Each week skills will be discussed and practiced in group, and a skills rehearsal homework activity will be assigned. Following the program, an 8-week follow-up review session will be offered. Additionally, a single 60 minute focus group will be held following the review session to solicit parent and adolescent feedback on the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Regulating Emotions Like An eXpert (RELAX) | Experimental | Families at the Virginia Commonwealth University Center for Psychological Services and Development or Clark-Hill Institute for Positive Youth Development Receives: Behavioral: RELAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotion Dysregulation
Parent and adolescent-reported emotion regulation on the Difficulties in Emotion Regulation Scale (DERS; Bunford et al., 2018; Kaufman et al., 2016). Total score is out of 180 (5 point Likert for each of 36 items). Higher scores indicate more difficulties with emotion regulation. RSA will be assessed with an EKG: three electrodes will be placed in a bipolar configuration on the left and right rib cage and the sternum. RSA is a measure of heart rate variability based on the respiratory cycle and is an indicator of vagal regulation (Berntson, Cacioppo, \& Quigley, 1997). Decreases in RSA, or RSA withdrawal, correspond to increased heart-rate and arousal; whereas, increases in RSA, or RSA augmentation, correspond to decreased arousal.
Measured: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)
Change in Family Conflict
Parent and adolescent-reported family conflict as measured by the Conflict Behavior Questionnaire (CBQ). The CBQ consists of 20 true-false questions, with higher scores indicating more conflict between parents and their children.
Measured: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)
Secondary outcomes (2)
Emotion Reactivity Predicting Treatment Outcomes
Baseline respiratory sinus arrhythmia (RSA) and RSA-Reactivity Predicting Change in Emotion Regulation and Family Conflict.
Measured: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)
Change in Emotion Socialization Predicting Treatment Outcomes
Observed emotion socialization predicting Emotion Regulation and Family Conflict. Observational emotion socialization will be coded during a parent-adolescent conflict discussion task. During this task adolescents will be instructed to share a recent parent-adolescent conflict that was a stressor for them, and the dyad will discuss the recent conflict for five minutes. The discussions will be coded for parent responses to adolescents' distress through seven possible reactions: emotion-focused, problem-focused, minimizing, punitive; magnifying, autonomy-inhibiting, and facilitative engagement. Responses will be coded on a 4-point scale representing an (1) absence, (2) minimal, (3) moderate, or (4) strong presence of the behavior reflected in each of the codes.
Measured: Baseline, Post-Intervention (Completion of 8 week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start30 Oct 2018
- Primary completion11 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhdStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Pilot trial to finish developing and refining the intervention
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Langberg, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733548
- Sponsor's protocol ID
- HM20013904
- Status last verified
- Aug 2019
- First submitted
- 2 Nov 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Emotion Regulation in Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT03733548
- Acronym / sponsor ID
- HM20013904
- Conditions
- Adhd
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 7 Nov 2018 (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 purpose of our study is to examine the impact of a program that provides emotion regulation skills for adolescents aged 11-16 with Attention-Deficit/Hyperactivity Disorder (ADHD) and poor emotion regulation. The program is called RELAX (Regulating Emotions Like An eXpert). RELAX is an experimental intervention that may equip adolescents with emotion regulation and conflict management skills and includes parent involvement to help parents support adolescents' use of these skills.
Detailed description
Regulating Emotions Like An eXpert (RELAX) consists of 8 weekly 90-minute group sessions and 1 booster session 8 weeks after the completion of the RELAX intervention. The first 60 minutes of each group involve separate parent and adolescent groups. Adolescents (ages 11-16) attend an emotion regulation and conflict management skills group, while parents attend a group focused on how to support utilization of these skills in adolescents at home and school through use of modeling their own emotion regulation skills and use of supportive emotion socialization practices. For the final 30 minutes of the session, parents and adolescents combine and complete a collaborative activity and skill rehearsal homework is discussed for the week. Homework will be discussed at the beginning of the separate group meetings the following week. The primary overall goal of the RELAX intervention is to assist adolescents and parents in traveling down the Path of RELAXation by working on the three C's (communication, coping, and conflict management skills). A multimethod assessment of emotional, social, and family functioning will be assessed pre- and post-intervention and at an 8 week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot trial to finish developing and refining the intervention
| Arm | Type | Receives |
|---|---|---|
| Regulating Emotions Like An eXpert (RELAX) | Experimental | Behavioral: RELAXFamilies at the Virginia Commonwealth University Center for Psychological Services and Development or Clark-Hill Institute for Positive Youth Development |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ADHD diagnosis
- parent-reported emotion regulation in the clinical range
- full scale intelligence quotient ≥80
- English as a primary language
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RELAXRegulating Emotions Like An eXpert (RELAX) consists of 8 weekly, 90-minute sessions delivered (60 minutes of parents and adolescents meeting separately, 30 minutes of a combined meeting) in a group format. RELAX equips adolescents with emotion regulation and conflict management skills. This program includes a parent involvement component designed to help parents support adolescents' use of these skills. Each week skills will be discussed and practiced in group, and a skills rehearsal homework activity will be assigned. Following the program, an 8-week follow-up review session will be offered. Additionally, a single 60 minute focus group will be held following the review session to solicit parent and adolescent feedback on the intervention. | Behavioural | Regulating Emotions Like An eXpert (RELAX) |
Primary outcome
Change in Emotion Dysregulation
Time frame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)
Parent and adolescent-reported emotion regulation on the Difficulties in Emotion Regulation Scale (DERS; Bunford et al., 2018; Kaufman et al., 2016). Total score is out of 180 (5 point Likert for each of 36 items). Higher scores indicate more difficulties with emotion regulation. RSA will be assessed with an EKG: three electrodes will be placed in a bipolar configuration on the left and right rib cage and the sternum. RSA is a measure of heart rate variability based on the respiratory cycle and is an indicator of vagal regulation (Berntson, Cacioppo, \& Quigley, 1997). Decreases in RSA, or RSA withdrawal, correspond to increased heart-rate and arousal; whereas, increases in RSA, or RSA augmentation, correspond to decreased arousal.
Change in Family Conflict
Time frame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)
Parent and adolescent-reported family conflict as measured by the Conflict Behavior Questionnaire (CBQ). The CBQ consists of 20 true-false questions, with higher scores indicating more conflict between parents and their children.
2 secondary outcomes
Emotion Reactivity Predicting Treatment Outcomes
Time frame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)
Change in Emotion Socialization Predicting Treatment Outcomes
Time frame: Baseline, Post-Intervention (Completion of 8 week intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No. No IPD will be shared.
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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.
Joshua Langberg, PhD principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELAX in people with Adhd, run by Virginia Commonwealth University at 2 sites in United States.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotion Dysregulation (time frame: Baseline, Post-Intervention (Completion of 8 week intervention), 8 week Follow-up (Approximately 2 months after completion of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2019.