Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Adolescent, ADHD
Brief summary
The proposed study will be an initial test of a cognitive-behavioral intervention for adolescents with ADHD who are receiving medication treatment. It is based on our successful work with adults with ADHD who have been treated with medicines but are still having symptoms. It involves learning skills for organization and planning, attention, and mood.
Detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is a prevalent, distressing, and interfering condition that affects between 2% and 6% of adolescents. Although medications have been widely used as an effective treatment for many years as the sole treatment for ADHD, for many, clinically significant and interfering continued symptoms remain. Even after medication treatment, adolescents still experience residual ADHD symptoms and continue to have problems with inattention, concentration, disorganization, and other symptoms. However, research suggests that adolescents who have received some benefit from medication treatment can then experience further symptom reduction from participation in skills-based cognitive behavioral therapy. This study, adapted from a similar research study for adults with ADHD, will examine whether cognitive behavioral therapy (CBT) plus medication is more effective at treating ADHD than medication therapy alone in adolescents with ADHD. Eligible participants will be randomly assigned to receive twelve weekly treatment sessions either immediately upon enrolling in the study or after a four-month waiting period. Questionnaires (that participants complete and ones that are done with an interviewer) will be used to assess participants' ADHD symptoms at study entry, after receiving the treatment, and at 4 month follow-up. Parents will have some involvement in therapy. Note: participants must be able to come to Boston or another study location in the Greater Boston area for 4 assessment visits and 12 weekly therapy visits in order for participation to be feasible.
Interventions
BEHAVIORALCognitive Behavioral Therapy (CBT)
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
Sponsors
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages of 14 and 18 * In high school * Principal Diagnosis of ADHD * Stable prescription of Medications for ADHD * ADHD has childhood onset * Clinically significant ADHD symptoms
Exclusion criteria
* Organic Mental Disorders * Active Substance Abuse or Dependence * Diagnosis of Conduct Disorder * Mental Retardation or Pervasive Developmental Disorder * Active Suicidality * Previous History of CBT Therapy in adolescence * Other condition interfering with consent or participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report | before randomization, 4-months, 8-months | -Independent blinded evaluator rated adolescent report of symptom severity (Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV). The independent evaluator administered the ADHD rating scale-IV to adolescent participants. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points. |
| Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating | before randomization, 4-months, 8-months | -Independent, blinded evaluator rating of ADHD symptom severity (Clinical Global Impressions - severity scale). The Clinical Global Impression (CGI) Scale is a widely used rating scale to measure overall severity related to ADHD symptoms. The Global Severity rating ranges from; 1=not ill, to 7= extremely ill, with higher scores indicating greater severity.The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points. |
| Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report | baseline, 4-months, and 8-months | -Independent blinded evaluator rated parent report of symptom severity (ADHD Rating Scale-IV) to the parent of the adolescent participant. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through passive methods (e.g., local radio advertising, flyers, social media), active outreach (e.g., mailing through the Research Patient Data Registry), and physician referrals.
Pre-assignment details
66 adolescents completed baseline eligibility procedures. 2 opted-out of treatment due to logistical constraints.18 were excluded pre-randomization: 6 exclusionary psychiatric comorbidity, 5 clinician-rated severity below threshold, for 4 ADHD not primary diagnosis, and 2 not taking ADHD medication, 1 had a medical condition that would interfere.
Participants by arm
| Arm | Count |
|---|---|
| CBT First, Then Follow-up All participants completed seven modules of treatment over twelve sessions, ten of which were 1:1 with the therapist and adolescent, and two of which also included the parent. Two additional optional parent-only sessions were offered as well. For each 1:1 session the parent was included for approximately ten minutes, generally at the end of the session, to discuss progress, the course of intervention content, and how the parent could assist with any take-home practice.
Modules were adapted from the PI's intervention designed for ADHD in adults. Modules included: psychoeducation and organization/planning (4 session); distractibility (2 sessions); adaptive thinking/cognitive restructuring (2 sessions); procrastination (1 session); parent-adolescent sessions (2 sessions); parent-only sessions (1 session); relapse prevention (1 session). | 24 |
| Wait List First, Then CBT Participants initially assigned to the wait list were informed by the research assistant that they had been randomized to the wait list condition. For those who were still willing to cross-over to receive CBT, the research assistant contacted parents to schedule the 4-month assessment visit with the independent evaluator and the first CBT session after the evaluation for participants. | 22 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Initial CBT for ADHD vs. Wait List | Moved out of Boston area | 1 | 0 |
| Initial CBT for ADHD vs. Wait List | Time constraints | 2 | 0 |
| Wait List Cross-over to CBT for ADHD | Lost to Follow-up | 0 | 5 |
| Wait List Cross-over to CBT for ADHD | Time constraints | 0 | 2 |
Baseline characteristics
| Characteristic | CBT First, Then Follow-up | Wait List First, Then CBT | Total |
|---|---|---|---|
| Age, Continuous | 15.17 years STANDARD_DEVIATION 1.01 | 15.09 years STANDARD_DEVIATION 1.11 | 15.13 years STANDARD_DEVIATION 1.05 |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 22 |
| serious Total, serious adverse events | 0 / 24 | 0 / 22 |
Outcome results
Primary
Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating
-Independent, blinded evaluator rating of ADHD symptom severity (Clinical Global Impressions - severity scale). The Clinical Global Impression (CGI) Scale is a widely used rating scale to measure overall severity related to ADHD symptoms. The Global Severity rating ranges from; 1=not ill, to 7= extremely ill, with higher scores indicating greater severity.The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.
Time frame: before randomization, 4-months, 8-months
Population: The CBT group is comprised of participants originally randomized to receive CBT who completed the intervention (N=21) plus participants initially randomized to the wait-list group who crossed-over to receive CBT and completed the intervention (N=15). The wait list control group is comprised only of those initially assigned to the wait list (N=22).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) for ADHD | Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating | -1.14 units on a scale | Standard Deviation 0.83 |
| Wait List Control | Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating | -0.09 units on a scale | Standard Deviation 0.68 |
p-value: <0.000195% CI: [0.94, 1.39]Mixed Models Analysis
Primary
Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report
-Independent blinded evaluator rated adolescent report of symptom severity (Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV). The independent evaluator administered the ADHD rating scale-IV to adolescent participants. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.
Time frame: before randomization, 4-months, 8-months
Population: The CBT group is comprised of participants originally randomized to receive CBT who completed the intervention (N=21) plus participants initially randomized to the wait-list group who crossed-over to receive CBT and completed the intervention (N=15). The wait list control group is comprised only of those initially assigned to the wait list (N=22).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) for ADHD | Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report | -4.27 units on a scale | Standard Deviation 6.27 |
| Wait List Control | Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report | -0.55 units on a scale | Standard Deviation 5.72 |
p-value: <0.000195% CI: [3.28, 7.21]Mixed Models Analysis
Primary
Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report
-Independent blinded evaluator rated parent report of symptom severity (ADHD Rating Scale-IV) to the parent of the adolescent participant. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.
Time frame: baseline, 4-months, and 8-months
Population: The CBT group is comprised of participants originally randomized to receive CBT who completed the intervention (N=21) plus participants initially randomized to the wait-list group who crossed-over to receive CBT and completed the intervention (N=15). The wait list control group is comprised only of those initially assigned to the wait list (N=22).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) for ADHD | Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report | -9.27 units on a scale | Standard Deviation 6.39 |
| Wait List Control | Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report | -3.86 units on a scale | Standard Deviation 6.84 |
p-value: <0.000195% CI: [8.93, 12.93]Mixed Models Analysis