NCT02226445

Brief Summary

The investigators knowledge of factors associated with treatment drop-out and missed appointments among adults with Attention-Deficit/Hyperactivity Disorder (ADHD) within a naturalistic, clinical setting is very limited. Drop-out rates among adult ADHD patients in randomised controlled trials (RCT´s) have been reported to be 26.6% - 50%, and similar rates are reported in two naturalistic studies of medication adherence. Based on proposed hypotheses that past behaviour patterns are more predictive of current behaviours of treatment drop-out and missed appointments than are sociodemographic and clinical characteristics, the aim of the present study is to examine the associations of 1) sociodemographic variables, 2) clinical variables, 3) risk-taking behaviour 4) educational and occupational instability and 5) behaviours during primary/lower secondary school with treatment drop-out and number of missed appointments. The target group of the study consists of all patients who initiates assessment at the adult ADHD Clinic at Regional Psychiatric Services West, Herning, Central Denmark Region in the period from September 1, 2010 to September 1, 2011. The patients are referred to this Clinic from general practitioners and specialised psychiatric authorities. The investigators study is designed as an observational, cohort study in which the patients are offered medical and non-manualised psychosocial treatment as it is usually offered in this tertiary ADHD Clinic from which the data are collected. Data regarding sociodemography, clinical symptoms and impairments, risk-taking behaviour, educational and occupational instability and behaviours during primary/lower secondary school are collected using a semistructured protocol. In the investigators study the investigators define treatment drop-out as premature termination of ongoing treatment, without any prior clinical or agreed resolution. No standardized definition of treatment drop-out is used through out the literature of adherence to treatment among patients in the psychiatric care system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
Last Updated

August 27, 2014

Status Verified

August 1, 2014

Enrollment Period

2.3 years

First QC Date

August 22, 2014

Last Update Submit

August 26, 2014

Conditions

Keywords

AdultsOutpatients

Outcome Measures

Primary Outcomes (2)

  • Treatment drop-out

    The outcome measure "treatment drop-out" is a binary outcome where participants at discharge are characterized as "drop-outs" or "non drop-outs". "Drop-outs" are defined as those participants, who terminate treatment without any prior clinical or agreed resolution. Logistic regression analyses is applied to calculate outcome odds ratios.

    Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year

  • Missed appointments

    The outcome measure "missed appointments" is a binary outcome, dichomized into \<3 missed appointments during treatment and ≥3 missed appointments during treatment. Logistic regression analyses is applied to calculate outcome odds ratios.

    Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year

Study Arms (1)

ADHD medication and psychosocial counseling

Other: Combined ADHD medication and psychosocial counseling

Interventions

The patients are offered as well ADHD medication as non-standardized psychosocial treatment, the latter including psychoeducation (i.e. information about ADHD aetiology and symptoms plus management of symptoms) and counselling regarding emotional-, family- and social rehabilitation-related problems. ADHD medication: First choice of medication is methylphenidate immediate release, initially 5 mg 2-3 times a day increasing with 10-20 mg per week up to stabilization of symptoms. When stabilized a shift to extended release methylphenidate. Alternatively dexamphetamine, initially 2.5 mg 2-3 times a day increasing with 5-10 mg per week up to stabilization of symptoms. If there is no adequate effect of central stimulants then a shift to atomoxetine, initially 18 mg a day, increasing during a period of 6-10 weeks up to max. 100 mg a day. If the patients have a substance use, an anxiety problem or other contraindications then first choice of medication is atomoxetine.

ADHD medication and psychosocial counseling

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to a tertiary ADHD Clinic at Regional Psychiatric Services West, Central Denmark Region

You may qualify if:

  • Referred to the ADHD Clinic and initiating assessment between September 1, 2010 and September 1, 2011

You may not qualify if:

  • No ADHD diagnosis as assessed by the ADHD Clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Research Unit West, Regional Psychiatric Services West

Herning, DK - 7400, Denmark

Location

Related Publications (1)

  • Soendergaard HM, Thomsen PH, Pedersen P, Pedersen E, Poulsen AE, Nielsen JM, Winther L, Henriksen A, Rungoe B, Soegaard HJ. Treatment dropout and missed appointments among adults with attention-deficit/hyperactivity disorder: associations with patient- and disorder-related factors. J Clin Psychiatry. 2016 Feb;77(2):232-9. doi: 10.4088/JCP.14m09270.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hans Jørgen Søgaard, MD, Ph.d.

    Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region

    STUDY CHAIR
  • Helle Møller Søndergaard, MSc

    Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region

    PRINCIPAL INVESTIGATOR
  • Per Hove Thomsen, Professor

    Center for Child and Adolescent Psychiatry, Aarhus University Hospital, Central Denmark Region

    STUDY CHAIR
  • Erik Pedersen, MD

    Regional Psychiatric Services West, Central Denmark Region

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2014

First Posted

August 27, 2014

Study Start

September 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 27, 2014

Record last verified: 2014-08

Locations