Trial Outcomes & Findings for Skills Training for Adolescents With ADHD (NCT NCT01019252)
NCT ID: NCT01019252
Last Updated: 2018-07-31
Results Overview
-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.
COMPLETED
NA
66 participants
before randomization, 4-months, 8-months
2018-07-31
Participant Flow
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.
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.
Participant milestones
| Measure |
CBT for ADHD 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. 21 of the participants crossed-over to the wait list condition (received no further treatment) between the 4-month and 8-month assessments.
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).
|
Wait List First, Then CBT for ADHD
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. 19 participants crossed-over to receive CBT between the 4-month and 8-month assessments. Of the 19 who crossed-over, 15 completed the CBT treatment.
|
|---|---|---|
|
Initial CBT for ADHD vs. Wait List
STARTED
|
24
|
22
|
|
Initial CBT for ADHD vs. Wait List
COMPLETED
|
21
|
22
|
|
Initial CBT for ADHD vs. Wait List
NOT COMPLETED
|
3
|
0
|
|
Wait List Cross-over to CBT for ADHD
STARTED
|
21
|
22
|
|
Wait List Cross-over to CBT for ADHD
COMPLETED
|
21
|
15
|
|
Wait List Cross-over to CBT for ADHD
NOT COMPLETED
|
0
|
7
|
Reasons for withdrawal
| Measure |
CBT for ADHD 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. 21 of the participants crossed-over to the wait list condition (received no further treatment) between the 4-month and 8-month assessments.
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).
|
Wait List First, Then CBT for ADHD
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. 19 participants crossed-over to receive CBT between the 4-month and 8-month assessments. Of the 19 who crossed-over, 15 completed the CBT treatment.
|
|---|---|---|
|
Initial CBT for ADHD vs. Wait List
Time constraints
|
2
|
0
|
|
Initial CBT for ADHD vs. Wait List
Moved out of Boston area
|
1
|
0
|
|
Wait List Cross-over to CBT for ADHD
Time constraints
|
0
|
2
|
|
Wait List Cross-over to CBT for ADHD
Lost to Follow-up
|
0
|
5
|
Baseline Characteristics
Skills Training for Adolescents With ADHD
Baseline characteristics by cohort
| Measure |
CBT First, Then Follow-up
n=24 Participants
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).
|
Wait List First, Then CBT
n=22 Participants
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.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.17 years
STANDARD_DEVIATION 1.01 • n=39 Participants
|
15.09 years
STANDARD_DEVIATION 1.11 • n=41 Participants
|
15.13 years
STANDARD_DEVIATION 1.05 • n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: before randomization, 4-months, 8-monthsPopulation: 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).
-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.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) for ADHD
n=36 Participants
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).
|
Wait List Control
n=22 Participants
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.
|
|---|---|---|
|
Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report
|
-4.27 units on a scale
Standard Deviation 6.27
|
-0.55 units on a scale
Standard Deviation 5.72
|
PRIMARY outcome
Timeframe: before randomization, 4-months, 8-monthsPopulation: 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).
-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.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) for ADHD
n=36 Participants
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).
|
Wait List Control
n=22 Participants
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.
|
|---|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating
|
-1.14 units on a scale
Standard Deviation .83
|
-0.09 units on a scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: baseline, 4-months, and 8-monthsPopulation: 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).
-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.
Outcome measures
| Measure |
Cognitive Behavioral Therapy (CBT) for ADHD
n=36 Participants
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).
|
Wait List Control
n=22 Participants
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.
|
|---|---|---|
|
Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report
|
-9.27 units on a scale
Standard Deviation 6.39
|
-3.86 units on a scale
Standard Deviation 6.84
|
Adverse Events
CBT for ADHD First, Then Follow-up
Wait List First, Then CBT for ADHD
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place