Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965622
Status:
RECRUITING
Last Update Posted:
2023-07-28
First Post:
2023-07-07
Brief Title:
Cost-Effectiveness of ABFT for Suicidal Youth
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Targeting Suicidality in Young Adults a Randomized Controlled Pragmatic Multicentre Trial Evaluating the Cost-Effectiveness of Attachment Based Family Therapy Compared to Treatment as Usual
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPAIR
Brief Summary:
Young adults who attempt to kill themselves is a common and serious mental health problem worldwide and certainly in Belgium and the Netherlands Fatal suicide is the leading cause of death among young adults It has devastating consequences both for the young adults themselves and for their families It also has substantial economic costs However up until now there is little research on the treatment of suicidality among young adults The current psychological therapy approaches and drug treatments for young people at very high risk of fatal suicide attempts have only limited success Increasing evidence indicates the importance of involving significant others in treatment and the importance of the unfulfilled need for belonging and secure attachment The WHO recommends involving significant others in the treatment of suicidal young adults However in Belgium and the Netherlands there is little knowledge on the effectiveness of family based treatments Attachment Based Family Therapy or ABFT was shown to work well in several studies in the US Also in Belgium and the Netherlands ABFT is being used to treat suicidal young adults However how well it works compared to the current treatment and if it provides good value for money have not been studied in young adults In the proposed study the investigators will test in a real-life situation whether ABFT works better than the current treatment and if it provides good value for money This study is a collaboration between the Netherlands and Belgium and 6 or 7 sites will participate from each country Sites can be hospitals mental health centres student health centres or private practices Participants 138 individuals are young adults between 18 and 25 years old who have frequent thoughts about killing themselves and who seek mental health treatment The investigators predict that compared to current treatment ABFT will reduce suicidal thoughts and suicide attempts and that this improvement will be maintained over time and that it will be better value for money The project will contribute to improving care for suicidal young adults with high suicide risk Results will inform clinical guidelines and policymakers and improve the treatment of young adults with a high risk for fatal suicide and their families
Detailed Description:
The investigators conduct a randomized controlled trial to evaluate the cost-effectiveness of ABFT compared to Treatment As Usual TAU on suicidality as delivered in daily practice The hypothesis is that compared to TAU ABFT will lead to a stronger reduction of suicidal ideation and suicidal behavior and will be more cost-effective will improve family functioning and young adult attachment and that this effect will hold at follow-up The primary objective is change in suicidality that is suicidal ideation attempts and suicide as assessed by the Suicidal Ideation Questionnaire Junior SIQ-JR and as reported by therapists during treatment Secondary objectives are cost-effectiveness process working alliance and adherence during treatment and change in young adult depressive symptoms family functioning and young adult attachment
Attachment Based Family Therapy ABFT ABFT is a manualized treatment that emerges from interpersonal theories that suggest suicide can be precipitated exacerbated or buffered against by the quality of family relationships Therefore ABFT focuses on strengthening parent-child attachment bonds to create a protective and secure base for young adult development Sessions are scheduled weekly and the intervention lasts on average 16 weeks Treatment as usual TAU Participants in both arms will receive TAU in the experimental condition ABFT will be delivered as an add-on Most treatment centres clinical practices rely heavily on the use of antidepressants andor CBT or DBT All regular interventions are allowed in TAU except for systemic family therapy of more than 4 sessions in total Parents are allowed to be involved in the treatment which is part of treatment as usual and can comprise for instance psycho-education or parental support or skill training
Attachment Based Family Therapy ABFT ABFT is a manualized treatment that emerges from interpersonal theories that suggest suicide can be precipitated exacerbated or buffered against by the quality of family relationships Therefore ABFT focuses on strengthening parent-child attachment bonds to create a protective and secure base for young adult development Sessions are scheduled weekly and the intervention lasts on average 16 weeks Treatment as usual TAU Participants in both arms will receive TAU in the experimental condition ABFT will be delivered as an add-on Most treatment centres clinical practices rely heavily on the use of antidepressants andor CBT or DBT All regular interventions are allowed in TAU except for systemic family therapy of more than 4 sessions in total Parents are allowed to be involved in the treatment which is part of treatment as usual and can comprise for instance psycho-education or parental support or skill training
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S65701 | REGISTRY | REPAIR study | None |