Suicidal IdeationREPAIRNCT05965622
(Cost)-Effectiveness of ABFT for Suicidal Youth.
A study testing Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU) and Treatment As Usual (TAU) in people with Suicidal Ideation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 13 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU) and Treatment As Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 5 Oct 2023to 14 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
Netherlands7 sites, 7 recruiting
- Recruiting
GGz Centraal
Amersfoort, Utrecht
Nienke de Ruiter, MSc, +31612490584, n.deruiter@ggzcentraal.nl
- Not yet recruiting
Academisch Medisch Centrum
Amsterdam, North Holland
Dominique Scheepens, Dr., +31208913600, d.s.scheepens@amsterdamumc.nl
- Recruiting
Arkin
Amsterdam, North Holland
Marthe Haanstra, Msc, +31654955795, marthe.haanstra@arkin.nl
- Not yet recruiting
Levvel
Amsterdam, North Holland
Ramón Lindauer, Prof.dr., +31205663383, R.Lindauer@debascule.com
- Recruiting
GGzE
Eindhoven, North Brabant
Daphne Remmers, Msc, +31651896953, daphne.remmers@ggze.nl
- Recruiting
GGZ Oost Brabant
Oss, North Brabant
Hanneke Niels, MSc, +31634238923, hanneke.niels@ggzoostbrabant.nl
- Recruiting
Kenter Jeugdhulp
Santpoort-Noord, North Holland
Nico Laats, MSc, +31620248696, nicolaats@kenterjeugdhulp.nl
Belgium6 sites, 6 recruiting
- Not yet recruiting
UGent Centrum Kind en Adolescent
Ghent, Oost-Vlaanderen, 9000
Caroline Braet, Prof., caroline.braet@ugent.be
Caroline Braet, Prof.
- Recruiting
UPC KU Leuven, campus Kortenberg
Kortenberg, Vlaams-Brabant, 3070
Kaat Van den Bossche, MSc, kaat.vandenbossche@upckuleuven.be
Nele Bergers, MSc
- Not yet recruiting
PraxisP
Leuven, Vlaams-Brabant, 3000
Els Joos, els.joos@kuleuven.be
Guy Bosmans, Prof.
- Recruiting
STUVO Psychologen en Psychiaters
Leuven, Vlaams-Brabant, 3000
Laura Deckers, MSc, laura.deckers@kuleuven.be
Nele Bergers, MSc
- Recruiting
Praktijk Annemie Uyttersprot
Merchtem, Vlaams-Brabant, 1785
Annemie Uyttersprot, MSc, annemie.uyttersprot@thomasmore.be
Nele Bergers, MSc
- Recruiting
Prakijkt ConnectUs
Tongeren, Limburg, 3700
Ellen Wos, MSc, ellen.wos@praktijkconnectus.be
Nele Bergers, MSc
About this study
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
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.
Read the 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
- Being tested
- Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU), Treatment As Usual (TAU)
- Keywords
- Suicidality in young adults, Attachment Based Family Therapy, (cost)-effectiveness
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU)Behavioural
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)Behavioural
The participants in the treatment as usual (TAU) condition will only receive regular existing care to treat suicidality in young adults.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Treatment As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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?'.
Measured: 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?'.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start5 Oct 2023
- Primary completion15 Nov 2025 (estimated)
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled, pragmatic, multicentre, trial in the Netherlands and Belgium with 13 participating sites.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, ZonMw: The Netherlands Organisation for Health Research and Development, Belgium Health Care Knowledge Centre
- Responsible party
- Principal investigator, Claudi Bockting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Nadia van der Spek, PhD, Study director, Academic Medical Center (AMC)Claudi Bockting, professor, Principal investigator, Academic Medical Center (AMC)Guy Bosmans, Professor, Study director, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965622
- Sponsor's protocol ID
- NL82274.018.22
- Other IDs
- S65701
- Acronym
- REPAIR
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39415182
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05965622
- Acronym / sponsor ID
- REPAIR / NL82274.018.22
- Conditions
- Suicidal Ideation
- Keywords
- Suicidality in young adults, Attachment Based Family Therapy, (cost)-effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- KU Leuven, ZonMw: The Netherlands Organisation for Health Research and Development, Belgium Health Care Knowledge Centre
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, controlled, pragmatic, multicentre, trial in the Netherlands and Belgium with 13 participating sites.
| Arm | Type | Receives |
|---|---|---|
| Attachment Based Family Therapy + Treatment As Usual | Experimental | Behavioral: Attachment Based Family Therapy (ABFT) + Treatment As Usual (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). |
| Treatment As Usual | Placebo comparator | Behavioral: Treatment As Usual (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). |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Attachment Based Family Therapy + Treatment As Usual |
| 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. | Behavioural | Treatment As Usual |
Primary outcome
Suicidality
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.
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.
13 secondary outcomes
Suicide ideation
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Suicide attempts
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Depression (DSM-5)
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Depressive symptoms
Time frame: 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
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.
Family functioning
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.
Attachment
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Health-related quality of life
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Disability
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Non-suicidal self-injury
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention,12 months after intervention.
Autonomy
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.
Entrapment
Time frame: 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
Time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 39415182Bockting 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadia van der Spek, PhD study director
Academic Medical Center (AMC)
Claudi Bockting, professor principal investigator
Academic Medical Center (AMC)
Guy Bosmans, Professor study director
KU Leuven
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU) and Treatment As Usual (TAU) in people with Suicidal Ideation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudi LH Bockting, Professor (+3120-8913600, c.l.bockting@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidality (time frame: Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.