Recruiting

Cognitive Behavioral TherapyCognitive Behavioral Therapy for Adolescents With Attention-Deficit / Hyperactivity Disorder

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT02566824

Conditions

Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

Interventions

Cognitive Behavioural & Skills Training

Supportive Group Therapy

Treatment as Usual - community resources

Methylphenidate or amphetamine product

Study Details

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study ID

NCT02566824

Start date

Oct, 2010

Status verified date

Jul, 2018

Completion date

Oct, 2020

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioural & Skills Training

Participants can choose to be on medication or not. If they decide to take medication, they will be titrated to an optimal dose of stimulant medication. Then they undergo the 12 weeks of group cognitive behavioral and skills training therapy.

active comparator: Supportive Group Therapy

active comparator: Treatment as Usual - community resources

Participants can choose to be on medication or not. If they decide to take medication, they will be titrated to an optimal dose of stimulant medication. Then they are referred to their treating physicians and are free to use any resources that are available to them in their communities.

Interventions

Cognitive Behavioural & Skills Training

This will be administered in groups of 10 participants in 12 sessions each lasting 1.5 hours. Each session will focus on a new topic- Modules will be introduced via role play illustrating the topic, followed by Q\&A. Strategies will be introduced to address the problems illustrated. Adolescents will practice using these strategies via planned activities or games. Obstacles to applying the skills in everyday life will be discussed and a physical reminder will be provided for each skill. A homework activity will be assigned to help participants practice the skill during the week. Each session will begin with homework review. Adolescents will also receive individual telephone coaching twice a week during the 12 weeks, which will taper off during the follow-up phase. Parents will also attend their own support group.

Supportive Group Therapy

This will be administered in groups of 10 participants in 12 sessions each session lasting 1.5 hours. During the initial session group members will be asked to identify a specific goal to address during the program. Each session will review the previous week's events (challenges and positive accomplishments) and psychoeducation on a topic relating to ADHD (topics will be elicited from group members at the outset of each session). Adolescents will also receive a telephone coaching at the same frequency as the CBT+S group participants. These phone calls will deal with issues a given participant had raised in the preceding session, and the approach will emphasize support and unconditional positive regard. Parents will also attend their own support group.

Treatment as Usual - community resources

The treatment as usual group reflects what patients currently receive in the community (mainly medication). Participants will be stabilized on optimal medication (if they choose to be on medication) and referred back to the community for follow-up. Participants are free to seek out any additional interventions that they feel are required. These participants will be evaluated at the same intervals as the two therapy groups. They will receive a follow-up phone call from the study coordinator at two-month intervals in-between evaluation points. If participants indicate during the phone call that they require services, they will be referred to services in the community.

Methylphenidate or amphetamine product

Medication is titrated over a 4-week period with stepwise increments each week. Participants, parents and teachers complete ADHD symptom scales at baseline and before each medication visit. They will also complete side effects scales at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the participants remain on this dose for the remainder of the study.

Primary outcome 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 [ Time Frame: At baseline - once medication is optimally titrated (if medication is chosen) ]
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 [ Time Frame: After 12 weeks of group treatment or 12 weeks after medication has been optimally titrated (if medication is chosen) ]
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 [ Time Frame: Four months after the end of group treatment or 7 1/2 months after medication has been optimally titrated (if medication is chosen) ]
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 [ Time Frame: Eight months after the end of group treatment or 11 1/2 months after medication has been optimally titrated (if medication is chosen) ]

Central Contacts and Locations

Central contacts

ADHD Research Program

514-412-4400 adolescent.adhd.cbt@gmail.com

Locations

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

ADHD Research Program

514-412-4400 adolescent.adhd.cbt@gmail.com

Principal Investigator:

Lily Hechtman, MD, FRCPC

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Jul 31, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2018-07-31.