Attention Deficit Hyperactivity Disorder, Deficient Emotional Self-Regulation
Conditions
Keywords
ADHD, Attention Deficit Hyperactivity Disorder, DESR, Deficient Emotional Self-Regulation, Emotional Dysregulation, Omega-3 Fatty Acids, Fish Oil
Brief summary
This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids for deficient emotional self-regulation (DESR) as a supplement to Attention Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR traits.
Interventions
DIETARY_SUPPLEMENTOmega-3 Fatty Acid
DRUGADHD Medication
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female children ages 6-17 years * Living at home * A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) based on clinical assessment * Having a score outside the normal (a T-score of 60 or greater) on the Emotional Control subscale of the Behavior Rating Inventory of Executive Function (parent-report version) or a score outside the normal range (cumulative of 180 or greater) on the Anxious/Depressed, Attention Problems, and Aggressive Behavior subscales of the Child Behavior Checklist for ages (6-18) * Currently on FDA approved traditional stimulant medication (such as Concerta of Adderall XR) or non-stimulant medication (such as Strattera or Tenex) for their ADHD for at least one month * Beings able to come to weekly/monthly study visits for 12 weeks * Having a parent or guardian with a level of understanding of the study
Exclusion criteria
* Having unstable medical illness as determined by the clinician investigator * Having a current diagnosis of schizophrenia or bipolar disorder * Having delusions or hallucinations * Having a bleeding disorder * Taking any other ongoing non-ADHD psychotropic medications other than stable, effective serotonin reuptake inhibitors such as fluoxetine (Prozac), citalopram (Celexa) or medications used on an as-needed basis * Pregnant or nursing females * IQ \< 70 by previous testing or as judged by the clinician investigator * Illegal substance use * Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild * Presence of suicidal risk, or homicidality * Unwilling/unable to comply with study procedures * Allergies to fish or shellfish or omega 3 fish oils; multiple adverse drug reactions * Poor command of the English language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) | Baseline and 12 Weeks | The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored Never, Sometimes, or Often. Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation. |
| Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR) | Baseline and 12 Weeks | The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse |
Countries
United States
Participant flow
Recruitment details
IRB-approved flyers were posted in the general community and throughout Massachusetts General Hospital between June 2014 and April 2016.
Participants by arm
| Arm | Count |
|---|---|
| Omega-3 Fatty Acids and Stimulant Treatment Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Omega-3 Fatty Acids and Stimulant Treatment |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.6 years STANDARD_DEVIATION 2.6 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 9 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)
The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
Time frame: Baseline and 12 Weeks
Population: Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Fatty Acids and Stimulant Treatment | Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR) | CGI Improvement for DESR Baseline | 4.6 units on a scale | Standard Deviation 0.7 |
| Omega-3 Fatty Acids and Stimulant Treatment | Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR) | CGI Improvement for DESR Endpoint | 3.0 units on a scale | Standard Deviation 0.9 |
Primary
Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored Never, Sometimes, or Often. Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation.
Time frame: Baseline and 12 Weeks
Population: Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omega-3 Fatty Acids and Stimulant Treatment | Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) | Emotional Control Subscale T Score Baseline | 65.3 units on a scale | Standard Deviation 10.2 |
| Omega-3 Fatty Acids and Stimulant Treatment | Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) | Emotional Control Subscale T Score Endpoint | 58.4 units on a scale | Standard Deviation 13 |