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Psychoeducational Groups for Adults With ADHD

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ClinicalTrials.gov Identifier: NCT03337425
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
Helse Nord-Trøndelag HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology

November 2, 2017
November 9, 2017
November 30, 2017
November 15, 2017
June 15, 2019   (Final data collection date for primary outcome measure)
  • Change in patient satisfaction [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    Measured with a modified version of the Client Satisfaction Questionnaire (CSQ-8). The scale consists of 8 items measured on a scale from 1 to 4. A sum score between 8 and 32 indicate the level of satisfaction with services provided.
  • Change in general self-efficacy [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    Measured with General Self-Efficacy Scale (GSE-6), a short-form measure of self-efficacy. Self-efficacy is regarded as a protective factor in adapting to stress and chronic illness. The scale consists of 6 items, measured on a 4-point scale, with a possible range of 6-24.
Same as current
Complete list of historical versions of study NCT03337425 on ClinicalTrials.gov Archive Site
  • Change in ADHD-related symptoms (ASRS) [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    Measured with ASRS, a self-reporting scale for ADHD-related symptoms in adults. The scale consists of 18 items, based on DSM-V diagnostic criteria for ADHD. The items are measured on a 5-point scale, with a possible range of 0-72.
  • Change in ADHD-related symptoms (SCL-9) [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    Measured with 9 items from the SCL-90. SCL-9 is an ADHD-specific scale, consisting of 9 items of the original 90. SCL-9 covers the specific characteristic traits of ADHD.
  • Change in ADHD-related quality of life [ Time Frame: Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) ]
    Measured with AAQoL - which covers ADHD-specific quality of life and function. AAQoL consists of 29 questions measuring health related quality of life among adults with ADHD.
Same as current
Not Provided
Not Provided
 
Psychoeducational Groups for Adults With ADHD
Psychoeducational Groups for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD): a Randomized Waitlist-controlled Multicenter Pilot Trial
This pilot study aims to assess patient satisfaction and preliminary efficacy of a psychoeducational group treatment, using a randomized waitlist-controlled trial, at two different outpatient clinics in mid-Norway. All participants will receive standard treatment during the intervention period. Assessment of client satisfaction (CSQ 8), general self-efficacy (GSE-6), ADHD-related quality of life (AAQoL) symptoms of ADHD (SCL-9; ASRS), and work participation will be conducted at time of recruitment prior to randomization (T0), pre- (T1), post-treatment (T2), with a 10 week follow-up.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
a Norwegian multicenter study
Masking: None (Open Label)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Behavioral: Psychoeducational group therapy
    The group-based psychoeducational program consists of 10 sessions, run over 10 consecutive weeks. Each session consist of a lecture, given by a recruited expert on the topic of the session (20 minutes) with a following discussion of the topic (45 minutes), facilitated by the course leader. All sessions are organized and led by the course leader, which also includes keeping structure in time, discussion and closing of the session. Psychoeducation comes in addition to standard treatment (ADHD treatment as usual).
  • Behavioral: Waiting list
    Waiting list and standard treatment (ADHD treatment as usual)
  • Other: Standard treatment
    Standard treatment consists of diagnostic assessment of ADHD and comorbidity, as well as treatment with medication. In addition, some patients receive cognitive behavioral therapy, although this is not systematically given to every patient. If needed, patients are also offered assistance with regard to economy, housing, education and work. As well as contact with family and network.
    Other Name: Treatment as usual
  • Experimental: psychoeducational groups
    Psychoeducational group therapy and standard treatment (ADHD treatment as usual)
    Interventions:
    • Behavioral: Psychoeducational group therapy
    • Other: Standard treatment
  • Active Comparator: Waiting list
    Waiting list and standard treatment (ADHD treatment as usual)
    Interventions:
    • Behavioral: Waiting list
    • Other: Standard treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
December 15, 2019
June 15, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • confirmed ADHD diagnosis
  • speaking a Scandinavian language

Exclusion Criteria:

  • not able or willing to give informed consent
  • psychosis
  • severe learning difficulties
Sexes Eligible for Study: All
18 Years to 67 Years   (Adult, Senior)
No
Contact: Jonas Rennemo Vaag, phd +47 40048820 jonas.vaag@ntnu.no
Contact: Terje Torgersen, phd +47 93419909 terje.torgersen@ntnu.no
Norway
 
 
NCT03337425
2016/1885
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Helse Nord-Trøndelag HF
Study Director: Gunnar Morken, prof Norwegian University of Science and Technology
Norwegian University of Science and Technology
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP