The Effect of a Brief Educational Intervention for Adults With ADHD

The Effect of a Brief Educational Intervention for Adults With ADHD: a Randomized Control 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.

Study Overview

• Status: Not yet recruiting
• Conditions: ADHD
• Intervention / Treatment: Behavioral: group-based combined with innovative technology education; Other: Standard treatment

Detailed Description

Community mental health centres (CMHCs) face significant challenges in meeting the needs of individuals with mental health issues. For example, due to high demand there are long waiting lists and low engagement rates. To address these challenges, innovative interventions are urgently needed to improve patient engagement, coping skills, and overall health outcomes. Educational and self-management interventions have shown promise in enhancing patient satisfaction and patient activation in other contexts and may therefore be potential solutions to reduce the identified challenges in the mental health service. To bridge these knowledge and practice gaps, this application proposes the evaluation of one educational intervention tailored specifically for adults with ADHD. This intervention aims to enhance patient engagement, treatment satisfaction, activation and overall outcomes.

The main hypotheses are that the new educational approach, developed in cooperation with user representatives, will result in higher patient engagement, increase patient satisfaction with the treatment, self-efficacy and patient activation.

The researchers hypothesized that the new educational intervention, through a brief group-based approach and in conjunction with standard clinical care, will improve patients' satisfaction, patients' self-efficacy, satisfaction with the information, as well as patient activation, compared to the usual treatment, in outpatient mental health settings.

This intervention has the potential to empower patients, increase their engagement in treatment, and improve their overall functioning. By demonstrating the efficacy of this approach, this research will inform clinical practice and contribute to the optimization of care for adults with ADHD.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariela Loreto Lara-Cabrera, PhD; Phone Number: +4748280188; Email: mariela.lara@ntnu.no
• Study Contact Backup: Name: Tatiana Skliarova, MD; Phone Number: +4748637421; Email: tatiana.skliarova@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway
    • St Olav's Hospital
    • Contact: Mariela Loreto Lara-Cabrera, PhD; Email: mariela.lara@ntnu.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Confirmed ADHD-diagnosis
• Speaking a Scandinavian language
• Willing to participate

Exclusion Criteria:

• Unable to give informed consent
• In-patient on a acute psychiatric ward
• Severe learning difficulties
• Involvement in other research studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational intervention; Patients randomized to the intervention group will start with peer co-led group-based psychoeducation, combined with digital video- and written information.	Behavioral: group-based combined with innovative technology education; 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.; Other Names: Treatment as usual
Active Comparator: Control group; The control group will receive treatment as usual after randomization	Other: Standard treatment; Treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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"	At baseline, 1 week before the intervention [pre-intervention], and at 4 weeks [post intervention]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in patient enablement using PEN-13	Patient Enablement-13 have 13 items. items are graded on a five/point scale and values can range from 13 (minimum enablement) to 65 points (maximum enablement).	At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in stress level using PSS-4	Perceived Stress Scale 4 (PSS-4), consists of 4 items. All items are rated on an ordinal 5-point scale, coded 0 through 4, and total score ranges from 0 to 16 where a higher score represents a higher subjective stress level.	At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in level of functioning using WSAS	Work and Social Adjustment scale (WSAS) consists of 5 items with the range from 0 (not at all) to 8 (very severely), with the total score from 0 to 40, where the higher score indicates more severe functional impairments.	At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in ADHD Quality of life using AAQoL	Quality of life was measured using the Adult ADHD quality of life scale (AAQoL). The AAQoL consists of 29 questions. Each item is rated on a 1 to 5 Likert scale. The total score ranges from 0 to 100. A higher score indicates higher quality of life.	At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]
Change in Health-related Quality of life using EQ-5D-5L	Quality of life was measured using the 5-level EQ-5D scale (EQ-5D-5L), which consists of 5 questions, that range on 5-point scale, which reflect the level of the dimension of the functions. Higher score indicates worse quality of life.	At baseline, 1 week before the intervention [pre-intervention], at 4 weeks [post intervention] and up to 56 weeks [follow up]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost	Cost development to evaluate its cost-benefit	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)	Up to 56 weeks [follow up]

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Mariela Loreto Lara-Cabrera, PhD, Norwegian University of Science and Technology; Study Chair: Rolf W. Gråwe, PhD, Prof., Norwegian University of Science and Technology; Study Chair: Liv S. Engvik, Cand Psychol, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: self-management; ADHD; patient education; patients' satisfaction; psychoeducation; general self-efficacy; self-management skills; group-based education; peer co-led
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 635362 a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No