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

NCT02566824 | Unknown Phase 4

• 1 other identifier: PED-05-055
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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 (3)

• Global functional impairment measured using Weiss Functional Impairment Rating Scale (WFIRS) completed by the adolescent and the parent - Change from baseline

  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

• Global functional impairment measured via Sheehan Disability Scale, completed by adolescent, parent, and a blind clinician - Change from baseline

  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

• Global functional impairment measured via Clinical Global Impression Scale (CGI) completed by a blind clinician - Change from baseline

  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

Study Arms (3)

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.

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.

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.

Other: Treatment as Usual - community resources; Drug: Methylphenidate or amphetamine product

Interventions

Cognitive Behavioural & Skills Training 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.

Cognitive Behavioural & Skills Training

Supportive Group Therapy 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.

Supportive Group Therapy

Treatment as Usual - community resources 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.

Treatment as Usual - community resources

Methylphenidate or amphetamine product 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.

Also known as: Ritalin, Concerta, Biphentin, Dexedrine, Adderall XR, Vyvanse

Cognitive Behavioural & Skills Training; Supportive Group Therapy; Treatment as Usual - community resources

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics; Methylphenidate; Dextroamphetamine; SLI381; Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines

Study Officials

• Lily Hechtman, MD, FRCPC

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ADHD Research Program

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 2, 2015
• Study Start: October 1, 2010
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)