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

NCT ID: NCT02566824

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2020-10-31

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behavioural & Skills Training

Intervention Type: BEHAVIORAL

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.

Methylphenidate or amphetamine product

Intervention Type: DRUG

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.

Supportive Group Therapy

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 supportive group therapy.

Group Type: ACTIVE_COMPARATOR

Supportive Group Therapy

Intervention Type: BEHAVIORAL

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.

Methylphenidate or amphetamine product

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual - community resources

Intervention Type: OTHER

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

Intervention Type: DRUG

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

Ritalin; Concerta; Biphentin; Dexedrine; Adderall XR; Vyvanse

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Lily Hechtman

Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lily Hechtman, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Montreal Children's Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

ADHD Research Program

Role: CONTACT

adolescent.adhd.cbt@gmail.com

514-412-4400 ext. 23286

Facility Contacts

ADHD Research Program

Role: primary

adolescent.adhd.cbt@gmail.com

514-412-4400 ext. 23286

Other Identifiers

PED-05-055

Identifier Type: -

Identifier Source: org_study_id