(Cost)-Effectiveness of ABFT for Suicidal Youth.

NCT ID: NCT05965622

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-05
• Study Completion Date: 2026-11-14

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 and/or 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.

Conditions

Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Attachment Based Family Therapy + Treatment As Usual

Attachment Based Family Therapy (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. Parent(s)/caregiver(s) will be involved in the therapy.

In the experimental group, patients will receive ABFT as an add-on therapy besides treatment as usual (TAU).

Group Type: EXPERIMENTAL

Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU)

Intervention Type: BEHAVIORAL

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.

The participants in the ABFT condition will also receive treatment as usual (TAU).

Treatment As Usual

Treatment as Usual (TAU) contains all regular interventions that are currently used to treat suicidality. In the TAU group, a limited number of systemic family therapy sessions will be given (maximum 4 sessions).

Group Type: PLACEBO_COMPARATOR

Treatment As Usual (TAU)

Intervention Type: BEHAVIORAL

The participants in the treatment as usual (TAU) condition will only receive regular existing care to treat suicidality in young adults.

Interventions

Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU)

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.

The participants in the ABFT condition will also receive treatment as usual (TAU).

Intervention Type: BEHAVIORAL

Treatment As Usual (TAU)

The participants in the treatment as usual (TAU) condition will only receive regular existing care to treat suicidality in young adults.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged between 18 and 25.
• A score above 31 on the SIQ-JR (the cut-off for suicidality).
• Have at least one primary parent or caregiver that participates in the assessment and treatment. This could be a biological parent, stepparent, grandparent, other relative, or a foster parent.

Exclusion Criteria

• Other DSM-5 disorders: substance dependency: severe alcohol or cannabis use disorder, all other substances: modest or severe substance use disorder.
• Severe conduct disorder.
• Evidence of psychotic features or prior psychosis (assessed with the SCID-5-S).
• Severe cognitive impairment (e.g., mental retardation, severe developmental disorders) as evidenced by educational records, parental report and/or clinical impression.
• Other circumstances that might affect participation (e.g., severe medical disorder, relocation).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Belgium Health Care Knowledge Centre

OTHER_GOV

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Claudi Bockting

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadia van der Spek, PhD

Role: STUDY_DIRECTOR

Academic Medical Center (AMC)

Claudi Bockting, professor

Role: PRINCIPAL_INVESTIGATOR

Academic Medical Center (AMC)

Guy Bosmans, Professor

Role: STUDY_DIRECTOR

KU Leuven

Locations

Prakijkt ConnectUs

Tongeren, Limburg, Belgium

Site Status: RECRUITING

UGent Centrum Kind en Adolescent

Ghent, Oost-Vlaanderen, Belgium

Site Status: NOT_YET_RECRUITING

UPC KU Leuven, campus Kortenberg

Kortenberg, Vlaams-Brabant, Belgium

Site Status: RECRUITING

PraxisP

Leuven, Vlaams-Brabant, Belgium

Site Status: NOT_YET_RECRUITING

STUVO Psychologen en Psychiaters

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Praktijk Annemie Uyttersprot

Merchtem, Vlaams-Brabant, Belgium

Site Status: RECRUITING

GGzE

Eindhoven, North Brabant, Netherlands

Site Status: RECRUITING

GGZ Oost Brabant

Oss, North Brabant, Netherlands

Site Status: RECRUITING

Academisch Medisch Centrum

Amsterdam, North Holland, Netherlands

Site Status: NOT_YET_RECRUITING

Arkin

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Levvel

Amsterdam, North Holland, Netherlands

Site Status: NOT_YET_RECRUITING

Kenter Jeugdhulp

Santpoort-Noord, North Holland, Netherlands

Site Status: RECRUITING

GGz Centraal

Amersfoort, Utrecht, Netherlands

Site Status: RECRUITING

Countries

Belgium; Netherlands

Central Contacts

Claudi LH Bockting, Professor

Role: CONTACT

c.l.bockting@amsterdamumc.nl

+3120-8913600

Nadia Van Der Spek, PhD

Role: CONTACT

n.vanderspek@amsterdamumc.nl

+31624138237

Facility Contacts

Ellen Wos, MSc

Role: primary

ellen.wos@praktijkconnectus.be

Caroline Braet, Prof.

Role: primary

caroline.braet@ugent.be

Kaat Van den Bossche, MSc

Role: primary

kaat.vandenbossche@upckuleuven.be

Els Joos

Role: primary

els.joos@kuleuven.be

Laura Deckers, MSc

Role: primary

laura.deckers@kuleuven.be

Annemie Uyttersprot, MSc

Role: primary

annemie.uyttersprot@thomasmore.be

Daphne Remmers, Msc

Role: primary

daphne.remmers@ggze.nl

+31651896953

Hanneke Niels, MSc

Role: primary

hanneke.niels@ggzoostbrabant.nl

+31634238923

Dominique Scheepens, Dr.

Role: primary

d.s.scheepens@amsterdamumc.nl

+31208913600

Marthe Haanstra, Msc

Role: primary

marthe.haanstra@arkin.nl

+31654955795

Ramón Lindauer, Prof.dr.

Role: primary

R.Lindauer@debascule.com

+31205663383

Nico Laats, MSc

Role: primary

nicolaats@kenterjeugdhulp.nl

+31620248696

Nienke de Ruiter, MSc

Role: primary

n.deruiter@ggzcentraal.nl

+31612490584

References

Bockting C, Bosmans G, Bergers N, Gavan L, Hiligsmann M, de Beurs D, Molenberghs G, Wijnen B, Lokkerbol J, van der Spek N. The effectiveness and cost-effectiveness of attachment-based family therapy for young adults with high suicidal ideation: protocol of a randomized controlled trial. Trials. 2024 Oct 16;25(1):686. doi: 10.1186/s13063-024-08499-7.

Reference Type: DERIVED

PMID: 39415182 (View on PubMed)

Other Identifiers

S65701

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL82274.018.22

Identifier Type: -

Identifier Source: org_study_id