None listed
Conditions
Brief summary
The present study is a pilot feasibility trial, aiming to evaluate the acceptability and feasibility of four novel digital single-session interventions aimed at addressing risk for self-injurious thoughts and behaviours in young people. This trial aims examine the acceptability of the novel interventions, and adherence the treatment protocol developed to encourage skill use and engagement after the session. Consistent with the aims of a pilot trial aiming to establish evidence for the study methods and procedures that are needed to inform a larger-scale trial, this study seeks address the following research questions: 1. Are the D-SSIs acceptable to adolescents and do they expect to benefit from them? 2. What role does ‘free choice’ of intervention have in treatment completion versus recommendation by a clinician? 3. How well do young people adhere to the post-intervention protocol (feasibility), and do those who had brief, warm follow-up contact have higher adherence to the post-intervention protocol? 4. What individual- and environmental factors are associated with adherence to the treatment protocol (both treatment completion and post-intervention skill use)? 5. What recruitment pathways most effectively enable us to reach and recruit adolescents who self-harm?
Interventions
Four novel digital single-session interventions (D-SSIs) have been developed, each to target one proximal risk factor/process to address risk for self-injurious thoughts and behaviours (SITBs). 1. Emotion regulation: teaches cognitive re-appraisal as the active therapeutic skill to increase access to strategies, reduce affective reactivity and experiential avoidance (i.e., increase emotion regulation self-efficacy). It is proposed that increasing emotion regulation self-efficacy will, in turn, reduce SITBs. 2. Self-criticism: teaches cognitive restructuring skills (e.g., thought challenging, learning about unhelpful thinking styles, etc.) with the aim of reduce cognitive biases, unhelpful thinking styles, and increasing self-compassion. It is proposed that reducing self-criticism and increasing a positive protective view of the self will in turn reduce SITBs. 3. Rumination: teaches decentering skills as the active therapeutic component, by introducing meta-awareness, promoting disidentification, and teaching cognitive diffusion. It is proposed that reducing ruminative processes will reduce reactivity to thought content, which will in turn reduce SITBs. 4. Hopelessness: teaches values-based, goal-driven behavioural activation as the active therapeutic strategy to increase state hope (pathways to goals and perceived agency), to reduce hopelessness, which in in turn is proposed to reduce SITBs. The trial is a randomised, 2×2 factorial pilot feasibility trial, whereby random allocation is used to compare the effects of (a) intervention assignment method (free choice vs. clinician recommendation) and (b) post-intervention brief telephone check-in (yes vs. no) on adherence to the intervention and post-intervention daily skill use and brief self-assessments. For the first randomisation, in one arm, participants will be provided with the D-SSI that best aligns with their risk profile (‘personalised’ arm), and in the other arm, participants will be presented with the four D-SSIs and allowed to select the one that most appeals to them (‘free choice’ arm). Highest standardised score on one of the four pre-screening measures (mapping onto the risk factor targeted per D-SSI) will determine allocation to the most appropriate D-SSI in the personalised arm. This will result in two primary groups (choice, no choice), with unequal distribution of D-SSIs per arm. However, neither condition is a true control group as both groups are receiving an active intervention. Further, the randomisation to a supportive check-in (brief phone call to assess any difficulties with adherence vs. no call) at 7 days post-intervention is to examine whether this call increases participant adherence to daily skill use and completion of the brief daily self-assessments the month following completion of the D-SSI. This approach will allow us to determine the specific contribution of the phone call check-in to supporting engagement with the post-intervention daily skill practice. This will help inform the design of the study and treatment protocol for a future larger scale effectiveness trial. Participant will then be presented with one D-SSI [recommended/personalised or free-choice] and provided with instructions to complete the intervention online [Qualtrics] in a single sitting. A D-SSI should take 30 minutes to complete in a single setting. After intervention completion, as a part of the treatment protocol, participants will be instructed to practice the skill introduced in the session (at least) once daily for the subsequent 28 days. Participants will only complete one of four D-SSIs as a part of this trial. Each D-SSI has introduction to the session content, explanation of the structure and purpose of the session, including setting session expectations (i.e., getting into ‘single-session mindset’, and post-session skill engagement). Each includes psychoeducational validation statements (regarding those who struggle with similar difficulties), and a brief, clinician-led psychoeducation video about maladaptive cycles [ ‘what might be keeping you feeling stuck’]. This includes the defining the struggle in specific behavioural terms for the young person. Then, a matched, active therapeutic skill will be introduced to the young person (e.g., decentering to help reduce emotional reactivity to thought content). This will include an animation, examples, written exercises, reflective questions, and multiple-choice questions to support the young person’s understanding and practice of the active therapeutic technique. The session will also include encouraging testimonials from other young people to positively reinforce skill engagement post-session. At the end of the session, a personalised action plan is provided, including a clear strategy, guidelines and instructions for daily skill engagement for the 28-days post intervention, as well as supplemental resources and emergency contacts. All materials and resources used were developed for the present study. Only the participants who were randomised to the 'brief call' condition will receive 1 brief call 7 days post-intervention. Intervention adherence will be assessed by examining if participants complete the intervention (in a single sitting), and if participants utilise the skill learned in the intervention for the subsequent 28 days. Regarding daily skill use, adherence to the intervention protocol means engaging in skill use on at least 75% of the days (at least 21/28 days). Given the possibility of daily assessment resulting in low response rates, opportunity will be given at follow-up to retrospectively report on daily skill use.
Sponsors
Study design
Eligibility
Inclusion criteria
This pilot study aims to recruit a national community-based sample of Australian adolescents who have had a recent experience with self-injurious thoughts and/or behaviours. 1. 15 to 19 years of age (confirmed via video call from the researchers) 2. Living in Australia 3. Fluent in English 4. Own and have access to a computer/laptop or smartphone 5. Have experienced self-injurious thoughts or behaviours (excluding suicide attempt) in the past 14 days
Exclusion criteria
1. Have a current diagnosis of psychosis or bipolar 2. Current active suicidal ideation with specific plan and intent 3. Suicide attempt in the last 30 days 4. Self-reported learning difficulty, visual impairment, or other difficulty that would make it challenging to answer questions on a computer, laptop, tablet, or smartphone 5. Enrolled and participating in another research trial.