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Clinical Trials/NCT00700089
NCT00700089CompletedPhase 4

AID-trial:A Randomized Clinical Trial Comparing the Effect on Repeated Self-harm of Assertive Intervention and Standard Treatment After Deliberate Self-harm

University of Copenhagen2 sites in 1 country243 target enrollmentStarted: November 2007Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
243
Locations
2
Primary Endpoint
Repeated fatal or non fatal suicidal act

Study Overview

Brief Summary

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.

Detailed Description

SPECIFIC AIMS/HYPOTHESES

The aim of this study 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.

BACKGROUND AND SIGNIFICANCE

Suicidal behavior is associated with considerable risk of subsequent self-harm, including completed suicide. Owens et al. (Owens, Horrocks, & House 2002a) conducted a systematic review of fatal and non-fatal repetition of self-harm. Owens found that the median one-year repetition rate was 16 percent non-fatal and two percent fatal. Results from the epidemiological European Multicentre Study (WHO/EURO) also shows a repetition rate between 12 and 30 percent within the first year, making suicide attempts a very important high-risk factor (Cedereke, Monti, & Ojehagen 2002;Schmidtke et al. 1996).

Unfortunately there are still very few randomized controlled trials with evidence based recommendations for suicide prevention. The studies conducted are often flawed due to selection bias or lack statistical power (Crawford et al. 2007;Hawton et al. 1998b;van der et al. 1997). A systematic review of randomised clinical trials of psychosocial and pharmacological interventions for persons who have attempted suicide revealed that until now, no intervention has proven effective in reducing suicide rate or repetition rate (Hawton et al. 1999). The authors identified non-significant trends toward reduced repetition of deliberate self-harm for problem-solving therapy compared with standard aftercare, for provision of an emergency contact card in addition to standard care compared with standard aftercare alone, and for intensive aftercare plus outreach compared with standard aftercare. In one relatively large study in this group, which evaluated community follow-up of patients who did not attend outpatient appointments, there was a near significant difference in repetition of deliberate self-harm of 10.7 percent compared with 17.4 percent (0.57; 0.32 to 1.02), (Van Heeringen et al. 1995).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
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

Outcomes

Primary Outcomes

Repeated fatal or non fatal suicidal act

Time Frame: one year

Secondary Outcomes

  • Use of hospital care(one year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Merete Nordentoft, Professor, DMSc.

Professor

University of Copenhagen

Study Sites (2)

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