Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

30. juli 2018 oppdatert av: Lily Hechtman, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

216

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Rekruttering
        • Montreal Children's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lily Hechtman, MD, FRCPC
        • Underetterforsker:
          • Robert Biskin, MD, FRCPC
        • Underetterforsker:
          • Mariya Cherkasova, PhD
        • Underetterforsker:
          • Norbert Schmitz, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 17 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Legemiddel: 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.
Andre navn:
  • Concerta
  • Vyvanse
  • Ritalin
  • Dexedrine
  • Biphentin
  • Adderall XR
Aktiv komparator: 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.
Legemiddel: 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.
Andre navn:
  • Concerta
  • Vyvanse
  • Ritalin
  • Dexedrine
  • Biphentin
  • Adderall XR
Atferdsmessig: 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.
Aktiv komparator: 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.
Legemiddel: 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.
Andre navn:
  • Concerta
  • Vyvanse
  • Ritalin
  • Dexedrine
  • Biphentin
  • Adderall XR
Annen: 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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Organizational skills (measured via Children's Organizational Skills Scale (COSS) completed by adolescent and parent) - Change from baseline
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
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

Andre resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Samarbeidspartnere

Canadian Institutes of Health Research (CIHR)

Etterforskere

  • Hovedetterforsker: Lily Hechtman, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2010

Primær fullføring (Forventet)

1. august 2020

Studiet fullført (Forventet)

1. oktober 2020

Datoer for studieregistrering

Først innsendt

30. september 2015

Først innsendt som oppfylte QC-kriteriene

1. oktober 2015

Først lagt ut (Anslag)

2. oktober 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juli 2018

Sist bekreftet

1. juli 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PED-05-055

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

There is no plan to make individual data available.

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere