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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation
• Intervention / Treatment: Behavioral: Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU); Behavioral: Treatment As Usual (TAU)

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 Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia Van Der Spek, PhD; Phone Number: +31624138237; Email: n.vanderspek@amsterdamumc.nl
• Study Contact Backup: Name: Claudi LH Bockting, Professor; Phone Number: +3120-8913600; Email: c.l.bockting@amsterdamumc.nl

Study Locations

• Belgium
  • Limburg
    • Tongeren, Limburg, Belgium, 3700
      • Recruiting
      • Prakijkt ConnectUs
      • Contact: Ellen Wos, MSc; Email: ellen.wos@praktijkconnectus.be
      • Sub-Investigator: Nele Bergers, MSc
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Not yet recruiting
      • UGent Centrum Kind en Adolescent
      • Sub-Investigator: Nele Bergers, MSc
      • Contact: Caroline Braet, Prof.; Email: caroline.braet@ugent.be
      • Principal Investigator: Caroline Braet, Prof.
  • Vlaams-Brabant
    • Kortenberg, Vlaams-Brabant, Belgium, 3070
      • Recruiting
      • UPC KU Leuven, campus Kortenberg
      • Sub-Investigator: Nele Bergers, MSc
      • Contact: Kaat Van den Bossche, MSc; Email: kaat.vandenbossche@upckuleuven.be
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Not yet recruiting
      • PraxisP
      • Contact: Els Joos; Email: els.joos@kuleuven.be
      • Principal Investigator: Guy Bosmans, Prof.
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • STUVO Psychologen en Psychiaters
      • Sub-Investigator: Nele Bergers, MSc
      • Contact: Laura Deckers, MSc; Email: laura.deckers@kuleuven.be
    • Merchtem, Vlaams-Brabant, Belgium, 1785
      • Recruiting
      • Praktijk Annemie Uyttersprot
      • Sub-Investigator: Nele Bergers, MSc
      • Contact: Annemie Uyttersprot, MSc; Email: annemie.uyttersprot@thomasmore.be
      • Principal Investigator: Annemie Uyttersprot, MSc
• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands
      • Recruiting
      • GGzE
      • Contact: Daphne Remmers, Msc; Phone Number: +31651896953; Email: daphne.remmers@ggze.nl
    • Oss, Noord-Brabant, Netherlands
      • Recruiting
      • GGZ Oost Brabant
      • Contact: Hanneke Niels, MSc; Phone Number: +31634238923; Email: hanneke.niels@ggzoostbrabant.nl
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands
      • Not yet recruiting
      • Academisch Medisch Centrum
      • Contact: Dominique Scheepens, Dr.; Phone Number: +31208913600; Email: d.s.scheepens@amsterdamumc.nl
    • Amsterdam, Noord-Holland, Netherlands
      • Recruiting
      • Arkin
      • Contact: Marthe Haanstra, Msc; Phone Number: +31654955795; Email: marthe.haanstra@arkin.nl
    • Amsterdam, Noord-Holland, Netherlands
      • Not yet recruiting
      • LEVVEL
      • Contact: Ramón Lindauer, Prof.dr.; Phone Number: +31205663383; Email: R.Lindauer@debascule.com
    • Santpoort-Noord, Noord-Holland, Netherlands
      • Recruiting
      • Kenter Jeugdhulp
      • Contact: Nico Laats, MSc; Phone Number: +31620248696; Email: nicolaats@kenterjeugdhulp.nl
  • Utrecht
    • Amersfoort, Utrecht, Netherlands
      • Recruiting
      • GGZ Centraal
      • Contact: Nienke de Ruiter, MSc; Phone Number: +31612490584; Email: n.deruiter@ggzcentraal.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide ideation	Assessed with the SCID-5-S, the Structured Clinical Interview for DSM-5 Syndrome Disorders (Michael B. First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017). The SCID-5-S is designed as a semi structured diagnostic interview for making the major DSM-5 diagnosis. Data obtained here are qualitative, f.i. 'Did you ever wish you were dead or that you would fall asleep and never wake up again? Can you tell me more about that?'.	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Suicide attempts	Assessed with the SCID-5-S, the Structured Clinical Interview for DSM-5 Syndrome Disorders (Michael B. First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017). The SCID-5-S is designed as a semi structured diagnostic interview for making the major DSM-5 diagnosis. Data obtained here are qualitative, f.i. 'did you ever try to kill yourself? If yes, what did you do? What happened then? Did you try to end your life?'.	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Depression (DSM-5)	Assessed with the SCID-5-S, the Structured Clinical Interview for DSM-5 Syndrome Disorders (Michael B. First, JBWW, Lorna Smith Benjamin, Robert L. Spitzer, 2017). The SCID-5-S is designed as a semi structured diagnostic interview for making the major DSM-5 diagnosis. When 5 or more criteria are scored positive (from A1 - A9), there is an indication for a depressive disorder.	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Depressive symptoms	Patient Health Questionnaire 9 (PHQ-9; Kroenke, Spitzer & Williams, 2001). With 0 = 'not at all' and 3 = 'nearly every day'. Scores of 1-4 = minimal depression, scores of 20-27 = severe depression.	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	Clinical Depression Inventory second edition (CDI-2; Bodden, Braet & Stikkelbroek, 2016). The CDI-2 for parents consists of 17 items, scored on a 4- point likert scale to indicate how often in the past 2 weeks symptoms occurred in their child. They respond to statements like "Looks sad" (0 not at all, 1 sometimes, 2 often, 3 almost always). A CDI-2 cut-off score of 16 is indicative of "significant" depressive symptoms according to the Dutch Mental Health Care guideline (Buitelaar et al., 2009: Multidisciplinaire Richtlijn GGZ, Addendum Depressie bij Jeugd, 2009).	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.
Family functioning	Self-Report Measures of Family Functioning (SRFF; Stark et al., 1990), both the emerging adult and the parent(s)/caregiver(s). The SRFF is composed of 15 five-item factors (e.g., cohesion, conflict, and democratic family style). Items are Likert-type scales rated from 1 (very untrue) to 4 (very true). Items that are scored in reverse are: 2, 4, 5, 8 and 9. A higher score reflects better family functioning.	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.
Attachment	To investigate whether ABFT improves young adult secure attachment, we will measure their Secure Base Script knowledge (i.e., implicit knowledge about how a care-related interaction unfolds, which participants only acquire if they are securely attached; Waters & Waters, 2006), using the Attachment Script Assessment (ASA; Waters & Waters, 2006; Waters et al., 2019; Waters & Roisman, 2019). The stories narrated by participants will be coded using a 7-point scale (higher scores reflect more SBS knowledge; H. S. Waters & Rodrigues-Doolabh, 2001). A score of 1 = no knowledge about a SBS, a score of 7 = a lot knowledge about a SBS.	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Health-related quality of life	Health-related quality of life: 5 Level EQ-5D (EQ-5D-5L; Versteegh et al., 2016). The EuroQOL five dimensions (EQ-5D) is a short questionnaire used to assess utilities at each measurement. Utilities are converted into Quality-Adjusted Life Years (QALYs), using Dutch and Belgian tariffs. Scoring works as followed: for instance for the item 'Mobility', a score of 1 = 'I have no problems in walking about' and a score of 5 = 'I am unable to walk about'. Higher scores on the EQ-5D-5L reflect more perceived problems (i.e. perceived by the patient).	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Disability	World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0; Ustun, Kostanjsek, Chatterji & Rehm, 2010).	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Non-suicidal self-injury	Non-suicidal self-injury questionnaire (Buelens, Luyckx, Kiekens, Gandhi, Muehlenkamp & Claes, 2020). This is a self-report 5-item questionnaire that measures non-suicidal self-injury. Items reflect qualitative data of which non suicidal self injury behaviors someone has exhibited.	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention,12 months after intervention.
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). Items are scored from 1 = 'not true at all' to 5 = 'totally true'. Some items (4, 6, 8, 13, 15) are scored in reverse. A higher score reflects less autonomy.	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.
Entrapment	Entrapment Short-Form Scale (E-SF; De Beurs et al., 2020). The E-SF is a 4-item questionnaire. Respondents are asked to indicate on a 5 point scale (0 = "not at all like me", 1 = "a bit like me", 2 = "moderately like me", 3 = "quite a bit like me", 4 = "extremely like me"), how much each statement applies to the respond. A higher score reflects a worse outcome (so a higher score reflects more entrapment feelings).	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.
Health care and associated costs and costs from productivity loss	Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P; Hakkaart-Van Roijen, 2002).	Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Trauma	Childhood Trauma Questionnaire (CTQ; Garnefski & Kraaij, 2001). This is a self-report 28-item questionnaire that measures 5 types of maltreatment: emotional, physical, and sexual abuse, and emotional and physical neglect. Items that are reverse coded, are: 2, 5, 7, 13, 19, 26, 28. Moderate-severe cutoff scores for each subscale are >= 13 for Emotional Abuse; >= 10 for Physical Abuse; >= 8 for Sexual Abuse; >= 15 for Emotional Neglect; and >= 10 for Physical Neglect.	Baseline.
Working Alliance Inventory	Working Alliance Inventory (WAI; Horvath & Greenberg, 1986). Measures overall therapeutic alliance and consists of sub scales measuring (quality of therapy) tasks, goals and bonds. Administered to emerging adult and the participating parent(s)/caregiver(s). The total score of the WAI is calculated by adding up all of the items. Reverse items, 4, 8, 12, 16, are scored inversely: (5=1) (4=2) (2=4) (1=5). A higher score represents a stronger alliance.	Every 2 months during intervention starting at the first session.
Treatment fidelity	Treatment fidelity and non-verbal contact will be assessed via scoring the videotapes that ABFT therapists made of their sessions. This will be done by a trained researcher using the The Therapist Behavior Rating Scale-3 (TBRS-3; Diamond, Hogue, Diamond & Siqueland, 1996). Scores are given on a 6 point Likert-scale, with 0 = 'not at all' and 6 = 'thoroughly'. A higher score reflects a better outcome.	Every 2 months during intervention starting at the first session
Therapy Procedure	Using the Therapy Procedure Checklist (TPC, Weersing, Wijs & Donenberg, 2002), which 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
Demographic characteristics and other parameters	Demographic characteristics: age, country of birth, current country, country of school, level of education, nationality, ethnicity, marital status, gender (or sex), ethnicity, level of education, gender identity (only applicable to young adults), medication use (only applicable to young adults), substance use (smoking, alcohol, drugs), gambling, psychiatric history (therapy, medication, number of previous episodes, duration of episodes and treatment), psychological help (current and past), number of siblings (only applicable to young adults), current family situation, number of children living at home (only applicable to parent(s)/caregiver(s)), relation to participant (only applicable to parent(s)/caregiver(s)), employment situation, work disability (if not employed), work disability benefit.	Baseline

Collaborators and Investigators

• 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
• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): November 14, 2026

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Suicidality in young adults; Attachment Based Family Therapy; (cost)-effectiveness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: NL82274.018.22; S65701 (Registry Identifier: REPAIR study)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No