Economic evaluation of an integrated individual and family therapy model for self-harming adolescents
| ISRCTN | ISRCTN15885573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15885573 |
| Secondary identifying numbers | Dnr: 2018/1902-32 |
- Submission date
- 08/07/2020
- Registration date
- 09/09/2020
- Last edited
- 27/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Olof Wijkmansväg 2
Morgongåva
74450
Sweden
 ORCID ID |
0000-0002-9442-3922 |
|---|---|
| Phone | +46 (0)76 1953709 |
| moa.brathen.wiijana@ki.se |
Study information
| Study design | Interventional study, within-group design with repeated measures |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | ICT - healthcare consumption |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2017 |
| Completion date | 25/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 25 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/10/2018 |
| Date of final enrolment | 25/11/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Uppsala
75237
Sweden
Sponsor information
University/education
K8 Klinisk neurovetenskap
Nobelsväg 7
Stockholm
17177
Sweden
| Phone | +46 (0)706112920 |
|---|---|
| moa.brathen.wiijana@ki.se | |
| Website | http://ki.se/en/startpage |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Jerringfonden
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The manuscript is ready to be submitted at the time of registration. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/07/2021 | 27/10/2022 | Yes | No |
Editorial Notes
27/10/2022: Publication reference added.
09/07/2020: Trial's existence confirmed by Regional Ethical Review Board in Stockholm.
