Clinical trial NCT01019252: Skills Training for Adolescents With ADHD
Official title: Compensatory Executive Functioning Skills Training in Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Adolescent
ADHD
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-11-25
Enrollment: 66
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report
timeFrame: before randomization, 4-months, 8-months
measure: Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating
timeFrame: before randomization, 4-months, 8-months
measure: Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report
timeFrame: baseline, 4-months, and 8-months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: University of Miami
name: Steven A. Safren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Susan E Sprich, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sprich SE, Safren SA, Finkelstein D, Remmert JE, Hammerness P. A randomized controlled trial of cognitive behavioral therapy for ADHD in medication-treated adolescents. J Child Psychol Psychiatry. 2016 Nov;57(11):1218-1226. doi: 10.1111/jcpp.12549. Epub 2016 Mar 17.