AID-trial Assertive Intervention After Deliberate Self-harm
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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 |
- Repeated fatal or non fatal suicidal act [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- 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 |
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| Denmark | |
| Mental Health Centre Copenhagen | |
| Copenhagen, Denmark, 2400 | |
| 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 May 22, 2013