(Cost)-Effectiveness of ABFT for Suicidal Youth.

Suicidal Ideation Clinical Trial

— REPAIR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965622
• Other study ID #: NL82274.018.22
• Secondary ID: S65701
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: November 14, 2026

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Claudi L.H. Bockting, Professor
• Phone: +3120-8913600
• Email: c.l.bockting[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: November 14, 2026
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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: modest/severe substance dependency, 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).

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
Netherlands	GGZ OostBrabant	Oss	Noord Holland

Sponsors (4)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Belgium Health Care Knowledge Centre, KU Leuven, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Childhood Trauma	Childhood Trauma Questionnaire (CTQ). This is a self-report 28-item questionnaire that measures 5 types of maltreatment: emotional, physical, and sexual abuse, and emotional and physical neglect.	Baseline
Other	Working Alliance Inventory	Working Alliance Inventory (WAI). Measures overall therapeutic alliance and consists of sub scales measuring (quality of therapy) tasks, goals and bonds. Admistered to young adult and the participating parent or caregiver.	Every 2 months during intervention starting at the first session
Other	Treatment fidelity	The Therapist Behavior Rating Scale-3 & non-verbal contact will be assessd via videotaping by a trained researcher.	Every 2 months during intervention starting at the first session
Other	Therapy Procedure	Therapy Procedures Checklist (TPC). It assesses therapists' reports of the techniques they employ when working with child and adolescent clients, and will be used to monitor Treatment as Usual in both study arms. TPC items encompass the 3 most common therapeutic models for youth: psychodynamic, cognitive, and behavioural.	Every 2 months during intervention starting at the first session
Other	Demographic characteristics and other parameters	Demographic characteristics: age, marital status, gender, ethnicity, level of education, medication use, substance use (smoking, alcohol, drugs), psychiatric history (therapy, medication, number of previous episodes, duration of episodes and treatment).	Baseline
Primary	Suicidality	Suicidality is assessed by the SIQ-JR. (Reynolds & Mazza, 1999)	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
Secondary	Suicide ideation	Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)	Measures change at: baseline, 5 months after baseline (after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
Secondary	Suicide attempts	Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)	Measures change at: baseline, 5 months after baseline (after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
Secondary	Depression (DSM 5)	Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)	Measures change at: baseline, 5 months after baseline (after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
Secondary	Depressive symptoms	Patient Health Questionnaire (PHQ-9).(Kroenke, Spitzer & Williams, 2001)	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
Secondary	Parental vision on the young adults depressive symptoms	Parental vision on the young adults depression symptoms Clinical Depression Inventory second edition (CDI-2) (Bodden, Braet,; & Stikkelbroek, 2016.) .	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
Secondary	Family functioning	Self Report Measures of Family Functioning (SRFF). (Stark et al., 1990), both the young adult and the parents/caregiver	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
Secondary	Attachment	Secure Base Script (SBS) task to asses attachment. (Waters et al., 2019; Waters & Roisman, 2019)	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
Secondary	Health-related quality of life	Health-related quality of life: EQ-5D-5L (Versteegh et al., 2016)	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
Secondary	Disability	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). (Ustun, Kostanjsek, Chatterji & Rehm, 2010)	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)
Secondary	Non-suicidal self-injury	Non-suicidal self-injury questionnaire.(Buelens, T., Luyckx, K., Kiekens, G., Gandhi, A., Muehlenkamp, J. J., & Claes, L. (2020).	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
Secondary	Autonomy	Autonomy of the young adult, as assessed by the questionnaire. My Parents and I, a combination of items of the Emotional Autonomy Scale (EAS; Steinberg & Zilverberg, 1986) and the Psychological Separation Inventory (PSI; Hoffman 1984).	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
Secondary	Entrapment	Entrapment Short-Form Scale (E-SF; De Beurs et al., 2020). The E-SF is a 4-item questionnaire.	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-mo after intervention (i.e. 8 mo after baseline), 6 mo after intervention (i.e11-mo after baseline) 12 mo after intervention(i.e.17 mo after baseline)
Secondary	Health care and associated costs and costs from productivity loss	Health care and associated costs and costs from productivity loss: TiC-P (Hakkaart-Van Roijen, 2002).	Measures change at: baseline, 5 months after baseline (immediately after intervention).Follow-up: 3-months after intervention (i.e. 8 months after baseline), 12-months after intervention (i.e. 17 months after baseline)