The Effect of a Brief Educational Intervention for Adults With ADHD

ConditionADHD

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorSt. Olavs Hospital

About this trial

This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Given the prevalent challenges of prolonged waiting lists and low patient engagement in CMHCs, the research seeks to assess the efficacy of this intervention in enhancing patient engagement, self-efficacy, satisfaction with the information and overall health outcomes. The intervention, developed collaboratively with user representatives, combines a brief group-based educational sessions with standard clinical care. The primary hypotheses posit that this approach will lead to increased patient satisfaction with the treatment, patient self-efficacy, and activation compared to conventional treatment. Additionally, it aims to improve patients' satisfaction with information received. The study will employ a ITT analysis to assess the intervention's effects against usual treatment practices in outpatient settings. The anticipated outcome is a significant improvement in level of patient satisfaction, level of self-efficacy and level of satisfaction with the received information for patients with ADHD, potentially informing clinical practices and optimizing care for adults with ADHD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed ADHD-diagnosis

Speaking a Scandinavian language

Willing to participate

Disqualifiers

Unable to give informed consent

In-patient on a acute psychiatric ward

Severe learning difficulties

Involvement in other research studies

Trial design

Design model

Parallel

Treatments tested in this trial

group-based combined with innovative technology education
Behavioral
The intervention combines brief group-based psychoeducation, and digital video- and written information, to deliver an early self-management educational program. The intervention introduces a group-breaking approach, featuring a self-managed peer co-led educational group, in collaboration with user representatives from Vårres and the ADHD organisation. This patient-centred educational programme covers crucial topics such as self-help tools, treatment options and experiences, patients' rights, and self-management, in addition to treatment as usual.
Standard treatment
Other intervention
Treatment as usual.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Educational interventionExperimental treatment 1 intervention

Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in client satisfaction using CSQ

Client satisfaction will be measured with Client Satisfaction Questionnaire 4 items (CSQ4). Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction), with higher scores indicating greater satisfaction.

Time frame

After the intervention up to 4 weeks [post intervention] and up to 56 weeks [follow up]

Change in general self-efficacy using GSE-6

General Self-Efficacy Scale is a 6-item scale with answers ranging from 1 ('not at all true') to 4 ('exactly true'). Total scores range from 6 to 24, with higher scores indicating greater self-efficacy.

Time frame

At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]

Change in satisfaction with the information

The satisfaction with the information survey includes 3 items, which score from 1 (not satisfied) to 5 (very satisfied), the option (I don't know) gives 0 points. The total score ranges from 3 to 15, with higher scores indicating higher satisfaction with the information

Time frame

At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]

Knowledge and treatment preferences

Knowledge will be measured by five questions answered on six-point ordinary scale, and one question answered as "yes", "no", "don't know"

Time frame

At baseline, 1 week before the intervention [pre-intervention], and at 4 weeks [post intervention]

Secondary outcomes

Change in patient activation using PAM

Patient activation will be measured with the Norwegian version of the Patient Activation Measure (PAM), which consists of 13 items, and total score ranges from 0 to 100, higher total score indicates higher patient activation

Time frame

At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]

Change in ADHD-related symptoms using ASRS

ADHD specific subscale and the ADHD Self-Report Scale (ASRS). Each item is answered on a five point scale ranging from 0 ("never") to 4 ("very often"). Higher scores indicates more pronounced symptoms.

Time frame

At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]

Change in ADHD-related symptoms using SCL-9

Hopkin's Symptoms Checklist 9-items (SCL-9), consists of nine items scored from 0 ("not at all") to 4 ("very much"), and the possible total score ranges from 0 to 36. The higher score in SCL-9 indicates more pronounced symptoms of the disorder.

Time frame

At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]

Change in depression and anxiety symptoms using PHQ-4

Patient Health Questionnaire for Depression and Anxiety (PHQ-4), consists of 4 items. Two questions assess anxiety symptoms, and two questions assess depression symptoms. Possible answers are given by a four-point scale ranging from "not at all" (0) to "nearly every day" (3), making a possible score range of 0-12. A higher score represents higher symptom severity.

Time frame

At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]

Other outcomes

Cost

Cost development to evaluate its cost-benefit

Time frame

Up to 56 weeks [follow up]

Health care usage

Data from official patient register will be used (drop out, number of consultations, type of treatment, length of treatment, attendance rates and diagnosis)

Time frame

Up to 56 weeks [follow up]

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Norwegian University of Science and Technology

Collaborator

Source ClinicalTrials.gov

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