AID-trial Assertive Intervention After Deliberate Self-harm

This study has been completed.
Sponsor:
Collaborators:
Mental Health Services in the Capital Region, Denmark
Ministry of Social Affairs
Information provided by (Responsible Party):
Merete Nordentoft, Professor, DMSc., University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00700089
First received: June 16, 2008
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

Background

Previous suicide attempts is a high-risk factor with a repetition rate between 12-30 percent. Compliance with after treatment is often poor. A systematic review by Hawton, 1999 states a lack of evidence on psychosocial interventions due to selections bias or statistical power.

Objective

The aim is to investigate if assertive outreach, incorporating hands-on guidance and motivational support of compliance with follow-up treatment after suicide attempts is able to reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.

Method and Design

A randomized, controlled intervention trial in a prospective design. The patients included will be randomized to either standard treatment (n = 120) or intervention treatment (N = 120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide attempts or deliberate self-harm. The outreach contacts are thought of as supporting and guiding home visits towards compliance with after care or follow-up treatment Inclusion criteria Males and females, aged 12 years or older with a recent suicide attempt or act of deliberate self-harm, living independently and not diagnosed with severe mental illness (psychosis, severe dementia)

Outcome

The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate self-harm registered in the medical records by the collaborating wards and units in their routine procedure of treating people applying for help in relation to suicidal behavior.


Condition Intervention Phase
Suicide, Attempted
Behavioral: Assertive intervention
Other: Standard treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: AID-trial:A Randomized Clinical Trial Comparing the Effect on Repeated Self-harm of Assertive Intervention and Standard Treatment After Deliberate Self-harm

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Repeated fatal or non fatal suicidal act [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Use of hospital care [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 243
Study Start Date: November 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
The concept is to support and guide the person shortly after the in-hospital treatment for self-injury through a recommended follow-up or after treatment based on assertive principles. The intervention is an indicated prevention strategy targeting people with suicide attempts and deliberate self-harm as a high-risk group. They will be offered 8-20 assertive outreach contacts. The outreach contacts will be home visits focusing on providing support and motivating patients to comply with follow-up treatment.
Behavioral: Assertive intervention
8-20 assertive contacts after suicide attempt
Placebo Comparator: B
Standard treatment consists of referral to a range of different treatment modalities depending on the diagnosis and clinical and social condition of the patient. In standard treatment there is no procedure for ensuring that the patient will actually receive the recommended treatment. Patients are often referred to available treatment modalities such as general practitioner, psychological treatment, treatment for alcohol abuse, and most often, the patients are themselves responsible for getting into contact with the treatment to which they are referred.
Other: Standard treatment
In standard treatment there is no procedure for ensuring that the patient will actually receive the recommended treatment. Patients are often referred to available treatment modalities such as general practitioner, psychological treatment, treatment for alcohol abuse, and most often, the patients are themselves responsible for getting into contact with the treatment to which they are referred.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Attempted suicide
  • At least 12 years old

Exclusion Criteria:

  • Psychotic disorder
  • Severe dementia
  • Institutionalised or hospitalised for more than 2 weeks at psychiatric department
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700089

Locations
Denmark
Mental Health Centre Copenhagen
Copenhagen, Denmark, 2400
Sponsors and Collaborators
University of Copenhagen
Mental Health Services in the Capital Region, Denmark
Ministry of Social Affairs
Investigators
Principal Investigator: Merete Nordentoft, Dr. Med Sc. Professor
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merete Nordentoft, Professor, DMSc., Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00700089     History of Changes
Other Study ID Numbers: AID-trial Copenhagen, Psychiatric Center Bispebjerg
Study First Received: June 16, 2008
Last Updated: March 20, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
Attempted suicide
Assertive intervention
Prevention
Treatment

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 16, 2014