Effects of Structured Skills Training Group in Treatment of ADHD in Adults

University of Oslo

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Other: Treatment as usual; Behavioral: Structural skills training group

Study type: Interventional

Funder types: Other

Identifiers

NCT02685254

2015/1523 A

Details and patient eligibility

About

This study aims to examine if structured skills training group therapy for ADHD in adults has beneficial effects superior to 'treatment as usual' including medication in a controlled outpatient setting on clinically relevant outcomes including symptoms, functioning and quality of life measures.

The trial is designed as a multicenter randomized controlled, parallel group study. Patients are randomized into 1 of 2 treatment arms with 14-week duration: one arm with initial intervention by structured skills training groups by weekly sessions or one with control condition (treatment as usual). Then after 15 weeks patients in the control condition arm are switched to the active intervention by 14 weeks of structured group therapy. All patients are assessed for defined outcomes after six months.

Full description

Background: The focus in recent years on evidence for non-pharmacological treatment in adults with ADHD raises the question of potential effects of structured group therapy. Structured skills training groups have shown beneficial effects in some studies in an outpatient psychiatric context by reduction in ADHD symptoms in individuals who remained stable regarding medication status.

Aims: The main objective for the trial is to investigate the potential effects of structured skills training groups in a clinically relevant but still controlled setting on broader outcomes including both symptomatic, functional and health related quality of life measures.

Methods/Design: The trial is designed as a multicenter randomized controlled parallel group design. At each outpatient site the enrolled patients are randomized into two groups for either Group 1 (G1) with start of weekly treatment in active structured skills training group lasting for 14 weeks or allocated to Group 2 (G2) with treatment as usual/clinical management and with 15 weeks delayed start of their group treatment for comparison wth patients in the other arm. Those patients in the control condition arm receiving treatment as usual or clinical management of individual patients (G2), are thereafter switched to active structured skills training group therapy.All patients are followed up after six months with assessments of primary and secondary outcomes.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) persisting in adulthood

Exclusion criteria

• Any psychotic disorder
• Recently suicidal behaviour
• Substance or alcohol abuse or dependence within three months prior to screening for inclusion
• Pervasive developmental disorder
• Intellectual disability
• Seizures or any neurological diseases causing mental handicap

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Initial group therapy

Experimental group

Description:

'Structural skills training group' - Start up with weekly structured skills training group for 14 weeks supplemented by homework training

Treatment:

Behavioral: Structural skills training group

Initial control condition

Other group

Description:

Treatment as usual/clinical management the first 15 weeks pending deferred start of group therapy (partially cross-over)

Treatment:

Other: Treatment as usual