In the proposed study, we 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. We hypothesize that, compared to TAU, ABFT will lead to…
ID
Source
Brief title
Condition
- Suicidal and self-injurious behaviours NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change suicidality as measured with the SIQ-JR, pre-post at baseline, 5.5, 8.5,
11.5 and 17.5 months after baseline.
Secondary outcome
The secondary outcomes are (fatal) suicide attempts (SCID-S), depression
(SCID-S,PHQ-9, and CDI-2), disability (WHODAS 2.0), family functioning (SRFF),
non-suicidal self injury (NSSI), young adult attachment (SBS), entrapment
(E-SF), autonomy (My Parents and I: a combination of items van de EAS en de
PSI), childhood trauma (CTQ), working alliance (WAI-12), ABFT treatment
fidelity (TBRS-3), treatment adherence (TPC), cost-effectiveness and health
care costs (EQ-5D-5L, TiC-P). The secondary study parameters will be analysed
using Generalized Linear Mixed Modelling with adequate link functions, using
all five assessment time points of the primary outcome measure
cost-effectiveness analyses.
Background summary
Young adult suicidality is worldwide and certainly in Belgium and the
Netherlands a prevalent mental health problem, and number one cause of death in
this group with devastating consequences for young adults and their families.
The economic costs of this health issue are substantial. However, the currently
recommended psychological treatments and guidelines targeting treatment of
suicidal youth at ultra-high risk for completed suicide have only limited
effectiveness. Counter-intuitively, the use of antidepressants in youth can in
some cases even increase suicide risk. In keeping with the WHO*s recommendation
to involve the family in treatment of these youth, Attachment Based Family
Therapy (ABFT) proved in several studies in the US promising effectiveness on
suicidality. In the Netherlands and Belgium, this treatment has been
implemented in mental health care settings in the past years and is becoming
increasingly popular among therapists. However, the (cost-) effectiveness of
ABFT in our countries has not been studied in young adults.
Study objective
In the proposed study, we 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. We hypothesize that, compared to
TAU, ABFT will lead to stronger reduction of suicide risk, 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.
Study design
A randomized, controlled, pragmatic, multicentre, trial in the Netherlands and
Belgium with 16 participating sites.
Intervention
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 burden and risks
There is no known risk associated with study participation. Patient burden
comprises four 30-45 minute assessment interviews, which can be held online of
by phone, and one questionnaires-only assessment, over the course of 17.5
months. The participants will be rewarded for their participation with
vouchers. The project will contribute to improving the care for suicidal young
adults with high mortality risk. Treatment of suicidal young adults is
understudied in the Netherlands and Belgium. Results will inform clinical
guidelines and policy makers and improve treatment of suicidal young adults in
The Netherlands and Belgium. Specifically, the involved national suicide
prevention foundations (i.e. 113.NL, the Flemish Expertisecentre
Suicideprevention (VLESP- Flanders), Un pas dans L*Impasse) (Suicide prevention
Wallonia), patient organisations and postdoctoral training centres will
guarantee further dissemination to daily treatment of suicidal young adults.
Meibergdreef 5
Amsterdam 1105AZ
NL
Meibergdreef 5
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Participants are suicidal young adults and their family. The young adults are
between 16 and 30 years old and seek mental health treatment. Participants will
be recruited from 16 participating sites.
Eligible participants meet the following inclusion criteria:
a) Aged between 16 and 30;
b) have a score of 31 or more on the SIQ-JR (the cut-off for suicidality);
c) 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
a) a) Other DSM-5 disorders: severe alcohol or cannabis use disorder, all other
substances: moderate or severe substance use disorder, severe conduct
disorder, evidence of psychotic features or prior psychosis (assessed with the
SCID-S);
b) severe cognitive impairment (e.g., mental retardation, severe developmental
disorders) as evidenced by educational records, parental report and/or clinical
impression;
c) other circumstances that might affect participation (e.g., severe medical
disorder, relocation).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL82274.018.22 |