NCT05965622

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
2 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Oct 2023Nov 2026

First Submitted

Initial submission to the registry

July 7, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2026

Expected
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

2.1 years

First QC Date

July 7, 2023

Last Update Submit

August 20, 2024

Conditions

Keywords

Suicidality in young adultsAttachment Based Family Therapy(cost)-effectiveness

Outcome Measures

Primary Outcomes (1)

  • Suicidality

    Suicidality is assessed by the Suicide Ideation Questionnaire Junior (SIQ-JR; Reynolds \& Mazza, 1999). Scores can range from 0 to 90, with a cut-off score of 31 indicating suicidality.

    Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.

Secondary Outcomes (13)

  • Suicide ideation

    Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.

  • Suicide attempts

    Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.

  • Depression (DSM-5)

    Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.

  • Depressive symptoms

    Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.

  • Parental vision on the young adults depressive symptoms

    Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.

  • +8 more secondary outcomes

Other Outcomes (5)

  • Childhood Trauma

    Baseline.

  • Working Alliance Inventory

    Every 2 months during intervention starting at the first session.

  • Treatment fidelity

    Every 2 months during intervention starting at the first session

  • +2 more other outcomes

Study Arms (2)

Attachment Based Family Therapy + Treatment As Usual

EXPERIMENTAL

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).

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

Treatment As Usual

PLACEBO COMPARATOR

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).

Behavioral: Treatment As Usual (TAU)

Interventions

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).

Attachment Based Family Therapy + Treatment As Usual

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

Treatment As Usual

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Prakijkt ConnectUs

Tongeren, Limburg, 3700, Belgium

RECRUITING

UGent Centrum Kind en Adolescent

Ghent, Oost-Vlaanderen, 9000, Belgium

NOT YET RECRUITING

UPC KU Leuven, campus Kortenberg

Kortenberg, Vlaams-Brabant, 3070, Belgium

RECRUITING

PraxisP

Leuven, Vlaams-Brabant, 3000, Belgium

NOT YET RECRUITING

STUVO Psychologen en Psychiaters

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Praktijk Annemie Uyttersprot

Merchtem, Vlaams-Brabant, 1785, Belgium

RECRUITING

GGzE

Eindhoven, North Brabant, Netherlands

RECRUITING

GGZ Oost Brabant

Oss, North Brabant, Netherlands

RECRUITING

Academisch Medisch Centrum

Amsterdam, North Holland, Netherlands

NOT YET RECRUITING

Arkin

Amsterdam, North Holland, Netherlands

RECRUITING

Levvel

Amsterdam, North Holland, Netherlands

NOT YET RECRUITING

Kenter Jeugdhulp

Santpoort-Noord, North Holland, Netherlands

RECRUITING

GGz Centraal

Amersfoort, Utrecht, Netherlands

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Nadia van der Spek, PhD

    Academic Medical Center (AMC)

    STUDY DIRECTOR
  • Claudi Bockting, professor

    Academic Medical Center (AMC)

    PRINCIPAL INVESTIGATOR
  • Guy Bosmans, Professor

    KU Leuven

    STUDY DIRECTOR

Central Study Contacts

Claudi LH Bockting, Professor

CONTACT

Nadia Van Der Spek, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Part of the research team that will collect and analyse the data are blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized, controlled, pragmatic, multicentre, trial in the Netherlands and Belgium with 13 participating sites.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 28, 2023

Study Start

October 5, 2023

Primary Completion

November 15, 2025

Study Completion (Estimated)

November 14, 2026

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations