Clinical trial NCT02566824: Cognitive Behavioral Therapy for Adolescents With Attention-Deficit / Hyperactivity Disorder
Official title: A Cognitive Behavioral Therapy Group Intervention for Adolescents With Attention-Deficit / Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-10-02
Enrollment: 216
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Attention Deficit/ Hyperactivity Disorder (ADHD) is a common childhood psychiatric condition, which often persists into adolescence. In adolescence ADHD is associated with poor academic, social, and emotional functioning, other psychiatric problems, substance abuse, and antisocial behaviour. Although medication effectively reduces symptoms such as hyperactivity and inattention, it does not directly address academic, social, emotional, and behavioural problems. Overcoming these would require building skills in organization, time management, problem solving, emotional modulation, stress management and interpersonal rapport. Yet, psychosocial treatments targeting such skills in adolescents with ADHD have been little studied and are scarce in the community. The proposed study will evaluate cognitive behavioural and skills training therapy (CBT+S) for adolescents with ADHD. Adolescents will decide whether they want to take medication to treat their ADHD symptoms. If they choose to be on medication, they will be stabilized on optimized medication and randomly assigned to 12 sessions of either manualized group cognitive behavioral and skills training therapy (CBT+S) or manualized supportive group therapy (SGT). An additional treatment-as-usual group will also be included. CBT+S will focus on skill acquisition in common problem areas for adolescents with ADHD, such as organization and time management, distractibility, impulsivity, and social skills. A coach will call each participant twice a week to help practice the learned skills.

Parallel groups will be provided for parents of CBT+S and SGT participants focusing on education, support and sharing experiences. If CBT+S proves to benefit adolescents with ADHD, it can be made widely available to these adolescents in the community. This would help them improve their academic, social, and emotional functioning and ultimately their long term outcomes.

Detailed description: Attention Deficit/ Hyperactivity Disorder (ADHD) is a prevalent childhood psychiatric condition affecting 5-10% of children worldwide. ADHD persists into adolescence in 70-80% of those diagnosed in childhood. In adolescence, ADHD is associated with impairments in academic, social, and emotional functioning, as well as with elevated rates of psychiatric comorbidities, substance abuse, and antisocial behaviour.

Medication is currently the mainstay treatment for adolescents with ADHD. Although medication is an efficacious treatment for core ADHD symptoms, it does not directly address the associated academic, social, emotional and behavioural impairments. Overcoming these would require skills in organization, time management, problem solving, emotional modulation, stress management and interpersonal rapport. While these skills are important in childhood, they become particularly indispensable as the child enters adolescence and is expected to function more autonomously. However, little is known about the efficacy of psychosocial treatments targeting such skills for adolescents with ADHD, and there are few psychosocial treatment options available to these adolescents in the community.

The purpose of the study will be to evaluate the efficacy of a novel integrative therapy that uses cognitive-behavioural approaches to foster the development of these skills in adolescents with ADHD. Adolescents with ADHD, ages 13-17, will be randomly assigned to either 12 sessions of manualized group cognitive behavioural and skills training therapy (CBT+S) or to 12 sessions of manualized supportive group therapy (SGT). The CBT+S sessions will focus on acquisition of skills targeting the common functional deficits of adolescents with ADHD, with the modules covering psychoeducation, goal attainment, organization, time management, focus training and distractibility reduction, impulse control, study skills, stress management, cognitive restructuring, anger management, social skills, and self-esteem. A coach will call each participant twice a week to help implement CBT+S strategies in daily life. Supportive group therapy (SGT) for the adolescents will focus on increasing understanding of ADHD, sharing experiences, and fostering a network of support. Calls from a coach will deal with participant-elicited issues. Parents of all adolescents will participate in parallel 6-session support groups similar to SGT and focused on psychoeducation, sharing and support. Treatment effects will be evaluated after 12 weeks of treatment. Maintenance of treatment benefits will be evaluated after 4 and 8 months of follow up. A treatment as usual group will be used to control for repeated measurements.

Eligibility criteria: Inclusion Criteria:

* Age 13 - 17 years
* The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) ADHD diagnosis confirmed by a psychiatrist
* Intelligent Quotient (IQ) \> 80 as per the Wechsler Intelligence Scale for Children -Fifth Edition (WISC-V)

Exclusion Criteria:

* History of Pervasive Development Disorder (PDD) or psychosis
* Significant brain traumas (encephalitis, head injury, etc.)
* Major medical conditions or impairments that would interfere with the ability of the adolescent to complete testing or take psychostimulants, e.g., epilepsy, cardiac abnormalities, or renal abnormalities
* Significant psychiatric comorbidities (e.g. suicidality) or substance abuse requiring immediate treatment.

Primary outcomes:
measure: Attention Deficit/Hyperactivity Disorder (ADHD) Symptomatology (measured via Conners' 3 Adolescent Self-Report Scale short form; Conners' 3 parent version; Conners' 3 teacher version) - Change from baseline
timeFrame: At baseline - once medication is optimally titrated (if medication is chosen)
measure: Attention Deficit/Hyperactivity Disorder (ADHD) Symptomatology (measured via Conners' 3 Adolescent Self-Report Scale short form; Conners' 3 parent version; Conners' 3 teacher version) - Change from baseline
timeFrame: After 12 weeks of group treatment or 12 weeks after medication has been optimally titrated (if medication is chosen)
measure: Attention Deficit/Hyperactivity Disorder (ADHD) Symptomatology (measured via Conners' 3 Adolescent Self-Report Scale short form; Conners' 3 parent version; Conners' 3 teacher version) - Change from baseline
timeFrame: Four months after the end of group treatment or 7 1/2 months after medication has been optimally titrated (if medication is chosen)
measure: Attention Deficit/Hyperactivity Disorder (ADHD) Symptomatology (measured via Conners' 3 Adolescent Self-Report Scale short form; Conners' 3 parent version; Conners' 3 teacher version) - Change from baseline
timeFrame: Eight months after the end of group treatment or 11 1/2 months after medication has been optimally titrated (if medication is chosen)
Secondary outcomes:
measure: Organizational skills (measured via Children's Organizational Skills Scale (COSS) completed by adolescent and parent) - Change from baseline
timeFrame: At baseline - optimally titrated (if medicated); after group treatment or 12 weeks after optimally titrated; 4 months after group treatment or 7 1/2 months after optimally titrated; 8 months after group treatment or 11 1/2 months after optimally titrated
measure: Emotional adjustment - (including ODD, conduct disorder symptoms, depression, and anxiety) measured via Stony Brook Child and Adolescent Symptom Inventory - 5 (CASI-5) completed by adolescent and parent - Change from baseline
timeFrame: At baseline - optimally titrated (if medicated); after group treatment or 12 weeks after optimally titrated; 4 months after group treatment or 7 1/2 months after optimally titrated; 8 months after group treatment or 11 1/2 months after optimally titrated
measure: Self-esteem - evaluated via Rosenberg Self Esteem Scale (RSES) completed by the adolescent - Change from baseline
timeFrame: At baseline - optimally titrated (if medicated); after group treatment or 12 weeks after optimally titrated; 4 months after group treatment or 7 1/2 months after optimally titrated; 8 months after group treatment or 11 1/2 months after optimally titrated
measure: Social skills measured via Social Skills Improvement System (SSIS) completed by adolescent and parent - Change from baseline
timeFrame: At baseline - optimally titrated (if medicated); after group treatment or 12 weeks after optimally titrated; 4 months after group treatment or 7 1/2 months after optimally titrated; 8 months after group treatment or 11 1/2 months after optimally titrated
measure: Parent-adolescent conflict measured via the Parent Issues Checklist- Revised completed by the parent - Change from baseline
timeFrame: At baseline - optimally titrated (if medicated); after group treatment or 12 weeks after optimally titrated; 4 months after group treatment or 7 1/2 months after optimally titrated; 8 months after group treatment or 11 1/2 months after optimally titrated
Other outcomes:
measure: Global functional impairment measured using Weiss Functional Impairment Rating Scale (WFIRS) completed by the adolescent and the parent - Change from baseline
timeFrame: At baseline - optimally titrated (if medicated); after group treatment or 12 weeks after optimally titrated; 4 months after group treatment or 7 1/2 months after optimally titrated; 8 months after group treatment or 11 1/2 months after optimally titrated
measure: Global functional impairment measured via Sheehan Disability Scale, completed by adolescent, parent, and a blind clinician - Change from baseline
timeFrame: At baseline - optimally titrated(if medicated); after group treatment or 12 weeks after optimally titrated; 4 months after group treatment or 7 1/2 months after optimally titrated; 8 months after group treatment or 11 1/2 months after optimally titrated
measure: Global functional impairment measured via Clinical Global Impression Scale (CGI) completed by a blind clinician - Change from baseline
timeFrame: At baseline - optimally titrated (if medicated); after group treatment or 12 weeks after optimally titrated; 4 months after group treatment or 7 1/2 months after optimally titrated; 8 months after group treatment or 11 1/2 months after optimally titrated
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Lily Hechtman, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: