(Cost)-Effectiveness of ABFT for Suicidal Youth.
- Conditions
- Suicidal Ideation
- Interventions
- Behavioral: Treatment As Usual (TAU)Behavioral: Attachment Based Family Therapy (ABFT) + Treatment As Usual (TAU)
- Registration Number
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 138
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment As Usual 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). Attachment Based Family Therapy + Treatment As Usual 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).
- Primary Outcome Measures
Name Time Method Suicidality 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.
- Secondary Outcome Measures
Name Time Method Depression (DSM-5) Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention. 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.
Disability Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0; Ustun, Kostanjsek, Chatterji \& Rehm, 2010).
Autonomy Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention. 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.
Suicide attempts Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention. 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?'.
Depressive symptoms Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention. 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.
Suicide ideation Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention. 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?'.
Health care and associated costs and costs from productivity loss Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention. Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P; Hakkaart-Van Roijen, 2002).
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. 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).
Family functioning Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention. 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.
Attachment Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention. 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.
Health-related quality of life Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 12 months after intervention. 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).
Non-suicidal self-injury Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention,12 months after intervention. 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.
Entrapment Measures change at: baseline, immediately after intervention, follow-up: 3 months after intervention, 6 months after intervention, 12 months after intervention. 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).
Trial Locations
- Locations (13)
Prakijkt ConnectUs
🇧🇪Tongeren, Limburg, Belgium
UPC KU Leuven, campus Kortenberg
🇧🇪Kortenberg, Vlaams-Brabant, Belgium
PraxisP
🇧🇪Leuven, Vlaams-Brabant, Belgium
STUVO Psychologen en Psychiaters
🇧🇪Leuven, Vlaams-Brabant, Belgium
Praktijk Annemie Uyttersprot
🇧🇪Merchtem, Vlaams-Brabant, Belgium
GGzE
🇳🇱Eindhoven, Noord-Brabant, Netherlands
GGz Centraal
🇳🇱Amersfoort, Utrecht, Netherlands
Kenter Jeugdhulp
🇳🇱Santpoort-Noord, Noord-Holland, Netherlands
UGent Centrum Kind en Adolescent
🇧🇪Gent, Oost-Vlaanderen, Belgium
GGZ Oost Brabant
🇳🇱Oss, Noord-Brabant, Netherlands
Levvel
🇳🇱Amsterdam, Noord-Holland, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Noord-Holland, Netherlands
Arkin
🇳🇱Amsterdam, Noord-Holland, Netherlands