Attention Deficit Hyperactivity DisorderPhase 4NCT02566824
Cognitive Behavioral Therapy for Adolescents With Attention-Deficit / Hyperactivity Disorder
A Phase 4 study testing Cognitive Behavioural & Skills Training, Supportive Group Therapy and Treatment as Usual - community resources in people with Attention Deficit Hyperactivity Disorder, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Cognitive Behavioural & Skills Training, Supportive Group Therapy and Treatment as Usual - community resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
ADHD Research Program, 514-412-4400 ext. 23286, adolescent.adhd.cbt@gmail.com
Lily Hechtman, MD, FRCPC
About this study
Official title: A Cognitive Behavioral Therapy Group Intervention for Adolescents With Attention-Deficit / Hyperactivity Disorder
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.
Read the 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
- Being tested
- Cognitive Behavioural & Skills Training, Supportive Group Therapy, Treatment as Usual - community resources, Methylphenidate or amphetamine product
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural & Skills TrainingBehavioural
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 TherapyBehavioural
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 resourcesOther
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 productDrug
Also called Ritalin, Concerta, Biphentin, Dexedrine
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural & Skills Training | Experimental | 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. Receives: Behavioral: Cognitive Behavioural & Skills Training; Drug: Methylphenidate or amphetamine product |
| Supportive Group Therapy | Active comparator | 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. Receives: Behavioral: Supportive Group Therapy; Drug: Methylphenidate or amphetamine product |
| Treatment as Usual - community resources | Active comparator | 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. Receives: Other: Treatment as Usual - community resources; Drug: Methylphenidate or amphetamine product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (5)
Organizational skills (measured via Children's Organizational Skills Scale (COSS) completed by adolescent and parent) - Change from baseline
Measured: 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
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
Measured: 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
Self-esteem - evaluated via Rosenberg Self Esteem Scale (RSES) completed by the adolescent - Change from baseline
Measured: 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
Social skills measured via Social Skills Improvement System (SSIS) completed by adolescent and parent - Change from baseline
Measured: 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
Parent-adolescent conflict measured via the Parent Issues Checklist- Revised completed by the parent - Change from baseline
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startOct 2010
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Lily Hechtman, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Lily Hechtman, MD, FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566824
- Sponsor's protocol ID
- PED-05-055
- Status last verified
- Jul 2018
- First submitted
- 30 Sep 2015
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual data available.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Behavioral Therapy Group Intervention for Adolescents With Attention-Deficit / Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02566824
- Acronym / sponsor ID
- PED-05-055
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2010
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural & Skills Training | Experimental | Behavioral: Cognitive Behavioural & Skills Training, Drug: Methylphenidate or amphetamine productParticipants 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. |
| Supportive Group Therapy | Active comparator | Behavioral: Supportive Group Therapy, Drug: Methylphenidate or amphetamine productParticipants 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. |
| Treatment as Usual - community resources | Active comparator | Other: Treatment as Usual - community resources, Drug: Methylphenidate or amphetamine productParticipants 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural & Skills TrainingThis 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. | Behavioural | Cognitive Behavioural & Skills Training |
| Supportive Group TherapyThis 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. | Behavioural | Supportive Group Therapy |
| Treatment as Usual - community resourcesThe 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. | Other | Treatment as Usual - community resources |
| Methylphenidate or amphetamine productAlso: Ritalin, Concerta, Biphentin, DexedrineMedication 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. | Drug | Cognitive Behavioural & Skills Training, Supportive Group Therapy, Treatment as Usual - community resources |
Primary outcome
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)
5 secondary outcomes
Organizational skills (measured via Children's Organizational Skills Scale (COSS) completed by adolescent and parent) - Change from baseline
Time frame: 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
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
Time frame: 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
Self-esteem - evaluated via Rosenberg Self Esteem Scale (RSES) completed by the adolescent - Change from baseline
Time frame: 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
Social skills measured via Social Skills Improvement System (SSIS) completed by adolescent and parent - Change from baseline
Time frame: 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
Parent-adolescent conflict measured via the Parent Issues Checklist- Revised completed by the parent - Change from baseline
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: No. There is no plan to make individual data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lily Hechtman, MD, FRCPC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive Behavioural & Skills Training, Supportive Group Therapy and Treatment as Usual - community resources in people with Attention Deficit Hyperactivity Disorder, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ADHD Research Program (514-412-4400 ext. 23286, adolescent.adhd.cbt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.