Treatment Drop-out and Missed Appointments Among Adults With ADHD

NCT ID: NCT02226445

Last Updated: 2014-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 153 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-01-31

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.

Conditions

Attention-Deficit/Hyperactivity Disorder; Drop-out; Non-adherence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ADHD medication and psychosocial counseling

Combined ADHD medication and psychosocial counseling

Intervention Type: OTHER

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.

Interventions

Combined ADHD medication and psychosocial counseling

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• No ADHD diagnosis as assessed by the ADHD Clinic

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Denmark Region

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Jørgen Søgaard, MD, Ph.d.

Role: STUDY_CHAIR

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

Helle Møller Søndergaard, MSc

Role: PRINCIPAL_INVESTIGATOR

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

Per Hove Thomsen, Professor

Role: STUDY_CHAIR

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

Erik Pedersen, MD

Role: STUDY_CHAIR

Regional Psychiatric Services West, Central Denmark Region

Locations

Psychiatric Research Unit West, Regional Psychiatric Services West

Herning, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 26761266 (View on PubMed)

Other Identifiers

ADHD/DO/MA

Identifier Type: -

Identifier Source: org_study_id