(Cost)-Effectiveness of ABFT for Suicidal Youth. (REPAIR)

• ClinicalTrials.gov Identifier: NCT05965622
• Recruitment Status: Recruiting
• First Posted: July 28, 2023
• Last Update Posted: July 28, 2023
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: KU Leuven; ZonMw: The Netherlands Organisation for Health Research and Development; Belgium Health Care Knowledge Centre
• Information provided by (Responsible Party): Claudi Bockting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Suicidal Ideation	Behavioral: Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU); Behavioral: Treatment As Usual (TAU)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized, controlled, pragmatic, multicentre, trial in the Netherlands and Belgium with 13 participating sites.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Part of the research team that will collect and analyse the data are blinded.
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: August 1, 2023
• Estimated Primary Completion Date: November 15, 2025
• Estimated Study Completion Date: November 14, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: ABFT + TAU; 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); 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).
Placebo Comparator: TAU; 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); The participants in the treatment as usual (TAU) condition will only receive regular existing care to treat suicidality in young adults.

Outcome Measures

Primary Outcome Measures :

1. Suicidality [ Time Frame: 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) ]
   Suicidality is assessed by the SIQ-JR. (Reynolds & Mazza, 1999)

Secondary Outcome Measures :

1. Suicide ideation [ Time Frame: 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) ]
   Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)
2. Suicide attempts [ Time Frame: 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) ]
   Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)
3. Depression (DSM 5) [ Time Frame: 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) ]
   Assessed with the SCID-5-S, DSM 5 diagnostic interview. Michael B.First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017)
4. Depressive symptoms [ Time Frame: 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) ]
   Patient Health Questionnaire (PHQ-9).(Kroenke, Spitzer & Williams, 2001)
5. Parental vision on the young adults depressive symptoms [ Time Frame: 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) ]

   Parental vision on the young adults depression symptoms Clinical Depression Inventory second edition (CDI-2) (Bodden, Braet,

   & Stikkelbroek, 2016.) .

6. Family functioning [ Time Frame: 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) ]
   Self Report Measures of Family Functioning (SRFF). (Stark et al., 1990), both the young adult and the parents/caregiver
7. Attachment [ Time Frame: 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) ]
   Secure Base Script (SBS) task to asses attachment. (Waters et al., 2019; Waters & Roisman, 2019)
8. Health-related quality of life [ Time Frame: 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) ]
   Health-related quality of life: EQ-5D-5L (Versteegh et al., 2016)
9. Disability [ Time Frame: 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) ]
   World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). (Ustun, Kostanjsek, Chatterji & Rehm, 2010)
10. Non-suicidal self-injury [ Time Frame: 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) ]
    Non-suicidal self-injury questionnaire.(Buelens, T., Luyckx, K., Kiekens, G., Gandhi, A., Muehlenkamp, J. J., & Claes, L. (2020).
11. Autonomy [ Time Frame: 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) ]
    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).
12. Entrapment [ Time Frame: 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) ]
    Entrapment Short-Form Scale (E-SF; De Beurs et al., 2020). The E-SF is a 4-item questionnaire.
13. Health care and associated costs and costs from productivity loss [ Time Frame: 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) ]
    Health care and associated costs and costs from productivity loss: TiC-P (Hakkaart-Van Roijen, 2002).

Other Outcome Measures:

1. Childhood Trauma [ Time Frame: Baseline ]
   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.
2. Working Alliance Inventory [ Time Frame: Every 2 months during intervention starting at the first session ]
   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.
3. Treatment fidelity [ Time Frame: Every 2 months during intervention starting at the first session ]
   The Therapist Behavior Rating Scale-3 & non-verbal contact will be assessd via videotaping by a trained researcher.
4. Therapy Procedure [ Time Frame: Every 2 months during intervention starting at the first session ]
   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.
5. Demographic characteristics and other parameters [ Time Frame: Baseline ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 25 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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: 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).

Contacts and Locations

Contacts

Contact: Claudi L.H. Bockting, Professor; +3120-8913600; c.l.bockting@amsterdamumc.nl

Contact: Nadia Van Der Spek, PhD; +31624138237; n.vanderspek@amsterdamumc.nl

Locations

Netherlands

GGZ OostBrabant; Recruiting

Oss, Noord Holland, Netherlands

Contact: Hanneke Niels, MSc +31634238923 hanneke.niels@ggzoostbrabant.nl

Sponsors and Collaborators

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

KU Leuven

ZonMw: The Netherlands Organisation for Health Research and Development

Belgium Health Care Knowledge Centre

Investigators

• Study Director: Nadia van der Spek, PhD; Academic Medical Center (AMC)
• Principal Investigator: Claudi Bockting, professor; Academic Medical Center (AMC)
• Study Director: Guy Bosmans, Professor; KU Leuven

More Information

• Responsible Party: Claudi Bockting, Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• ClinicalTrials.gov Identifier: NCT05965622
• Other Study ID Numbers: NL82274.018.22; S65701 ( Registry Identifier: REPAIR study )
• First Posted: July 28, 2023
• Last Update Posted: July 28, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Claudi Bockting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Suicidality in young adults; Attachment Based Family Therapy; (cost)-effectiveness

Additional relevant MeSH terms:

Suicidal Ideation; Suicide; Self-Injurious Behavior; Behavioral Symptoms