Plain English Summary
Background and study aims
Self-harming behaviors in adolescents cause great suffering and can lead to considerable costs to the healthcare system. The aim of the study is to investigate the cost of an integrated individual and family therapy (Intensive Contextual Treatment: ICT) and to compare the adolescent’s healthcare consumption 1 year before and 1 year after treatment.
Who can participate?
Adolescents (aged 13-19) with repetitive self-harm behavior within the past 3 months and their families
What does the study involve?
ICT is an intensive, short term (3-6 months) treatment. It is an outreach treatment conducted in the families residences and by two therapists. The frequency of the intervention is 2-3 meetings per week, the duration of the intervention is on average 4.5 months. The follow-up is 6 and 12 months after the intervention for the outcome measures, and healthcare consumption data is collected 1 year before, during and 1 year after treatment.
What are the possible benefits and risks of participating?
Participation in this follow-up study requires nothing more than written consent. Compilation of data is at a group level and therefore no individuals can be identified. Regarding benefits, the results of the present study can inform decision-makers in prioritizing. In times when resources in healthcare are scarce in relation to needs, it is important to be able to document healthcare utilization.
Where is the study run from?
Uppsala academic hospital (Sweden)
When is the study starting and how long is it expected to run for?
October 2017 to November 2019
Who is funding the study?
Uppsala academic hospital (Sweden)
Who is the main contact?
Moa Bråthén Wijana
moa.brathen.wiijana@ki.se
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Moa Bråthén Wijana
ORCID ID
https://orcid.org/0000-0002-9442-3922
Contact details
Olof Wijkmansväg 2
Morgongåva
74450
Sweden
+46 (0)76 1953709
moa.brathen.wiijana@ki.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Dnr: 2018/1902-32
Study information
Scientific title
Impact of an integrated individual and family therapy model for self-harming adolescents on overall healthcare consumption. A pilot study of a Swedish sample
Acronym
ICT - healthcare consumption
Study hypothesis
The primary hypothesis is that the patients would reduce their need for specialized healthcare consumption when comparing a 1-year period before and an equal period after treatment. The secondary hypothesis was that there would be a relationship between treatment effects and the changes in healthcare consumption.
Ethics approval
Approved 03/10/2018, Regional Ethical Review Board in Stockholm (Regionala etikprövingsnämnden, Karolinska Institutet, Tomtebodavägen 18 A, 171 65 Solna, Sweden; +46 (0)852480000; no email provided), ref: Dnr: 2011/1593-31/5, Dnr: 2018/1902-32
Study design
Interventional study, within-group design with repeated measures
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Self-harm and suicidal behaviors in adolescents
Intervention
ICT (integrated individual and family therapy model for self-harming adolescents) is an intensive, short term (3-6 months) treatment. It includes components from dialectical behavior therapy and functional family therapy. It is an outreach treatment conducted in the families residences and by two therapists. ICT has a contextual focus and close collaboration with schools is desirable. The frequency of the intervention is 2-3 meetings per week, the duration of the intervention is on average 4.5 months. The follow-up is 6 and 12 months post-intervention for the outcome measures, and for healthcare consumption, data is collected retrospectively 1 year before, during and 1 year after treatment.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Self-harm measured using self-assessment Deliberate Self-Harm Inventory (DSHI-9r) at pre- and post-treatment and 6 and 12 months follow-up
2. Healthcare consumption measured using medical records 1 year before, during and 1 year after treatment
Secondary outcome measures
General mental health symptoms measured using youth self-report (YSR) at pre- and post-treatment and 6 and 12 months follow-up
Overall trial start date
01/10/2017
Overall trial end date
25/11/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 13-19
2. Repetitive self-harm behavior within the past 3 months, defined as both deliberate self-poisoning and self-injury, or suicidal thoughts, threats or plans
3. Live together with at least one primary caregiver
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Total final enrolment
25
Participant exclusion criteria
1. Reported psychiatric disorder (e.g., schizophrenia) requiring intensive in-patient stabilization (as assessed at baseline with a semi-structured diagnostic interview)
2. Insufficient comprehension of Swedish language
3. Severe substance abuse
4. Developmental disabilities
Recruitment start date
10/10/2018
Recruitment end date
25/11/2019
Locations
Countries of recruitment
Sweden
Trial participating centre
IKB-teamet, BUP, akademiska sjukhuset
Dag Hammarskjöldsväg 13
Uppsala
75237
Sweden
Sponsor information
Organisation
Karolinska Institute
Sponsor details
K8 Klinisk neurovetenskap
Nobelsväg 7
Stockholm
17177
Sweden
+46 (0)706112920
moa.brathen.wiijana@ki.se
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Stiftelsen Sven Jerrings Fond
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The manuscript is ready to be submitted at the time of registration.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Moa Bråthén Wijana (moa.brathen.wiijana@ki.se). The data is raw data and scale scores in SPSS files or Excel files. There is no time limit for data access and it is available from now on. Data is primarily available for persons who may be involved in a review of the manuscript. The data files are all anonymized so there should be no problems with confidentiality. The consent from participants applies to analyzes at group level, i.e. descriptive statistics and group comparisons.
Intention to publish date
01/08/2020
Participant level data
Available on request
Basic results (scientific)
Publication list