AID-trial Assertive Intervention After Deliberate Self-harm

NCT00700089 | Completed Phase 4 DMC

• 2 other identifiers: AID-trial CopenhagenPsychiatric Center Bispebjerg
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted

Keywords

Attempted suicide; Assertive intervention; Prevention; Treatment

Outcome Measures

Primary Outcomes (1)

• Repeated fatal or non fatal suicidal act

  one year

Secondary Outcomes (1)

• Use of hospital care

  one year

Study Arms (2)

A

EXPERIMENTAL

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

B

PLACEBO COMPARATOR

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

Interventions

Assertive intervention BEHAVIORAL

8-20 assertive contacts after suicide attempt

A

Standard treatment OTHER

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.

B

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Attempted suicide
• At least 12 years old

You may not qualify if:

• Psychotic disorder
• Severe dementia
• Institutionalised or hospitalised for more than 2 weeks at psychiatric department

Sponsors & Collaborators

• University of Copenhagen: lead
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator
• Ministry of Social Affairs, Denmark: collaborator

Study Sites (1)

Mental Health Centre Copenhagen

Copenhagen, 2400, Denmark

Location

Related Publications (2)

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

  PMID: 33884617 DERIVED

• Morthorst B, Krogh J, Erlangsen A, Alberdi F, Nordentoft M. Effect of assertive outreach after suicide attempt in the AID (assertive intervention for deliberate self harm) trial: randomised controlled trial. BMJ. 2012 Aug 22;345:e4972. doi: 10.1136/bmj.e4972.

  PMID: 22915730 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Merete Nordentoft, Dr. Med Sc.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 18, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

DK (1)