Psychoeducational Groups for Adults With ADHD

Study Overview
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Brief Summary
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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.

Official Title
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Psychoeducational Groups for Adults With Attention-Deficit Hyperactivity/Impulsivity Disorder (ADHD): a Randomized Waitlist-controlled Multicenter Pilot Trial

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Psychoeducational group therapy
* Behavioral: Waiting list
* Other: Standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed ADHD diagnosis speaking a Scandinavian language Exclusion Criteria: not able or willing to give informed consent psychosis severe learning difficulties

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: a Norwegian multicenter study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psychoeducational groups<br>Psychoeducational group therapy and standard treatment (ADHD treatment as usual) | Behavioral: Psychoeducational group therapy<br>* 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).<br>Other: Standard treatment<br>* 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.<br>* Other names: Treatment as usual;|
| Active Comparator: Waiting list<br>Waiting list and standard treatment (ADHD treatment as usual) | Behavioral: Waiting list<br>* Waiting list and standard treatment (ADHD treatment as usual)<br>Other: Standard treatment<br>* 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.<br>* Other names: Treatment as usual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient satisfaction | 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. | Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) | 
| Change in general self-efficacy | 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. | Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADHD-related symptoms (ASRS) | 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. | Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) | 
| Change in ADHD-related symptoms (SCL-9) | 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. | Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) | 
| Change in ADHD-related quality of life | 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. | Baseline, post-intervention (10 weeks) and after 10 weeks follow-up (20 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, group, Adults