None listed
Conditions
Brief summary
Researchers at the Black Dog Institute have developed a new digital mental health tool for children aged 8 to 10 years who worry or experience low mood. The goal of the program is to help children to develop healthier thinking habits to help with their worry and low mood. In this study, we are conducting a clinical trial to evaluate whether the program is beneficial for children’s mental health. The current project will investigate the efficacy of a novel Cognitive Bias Modification of Interpretations (CBM-I) intervention for children with elevated symptoms of anxiety and/or depression. The CBM-I program has been developed in consultation with children, parents and mental health professionals to maximise engagement and relevance of content and features for children with anxiety and depressive concerns. Children aged 8-10 years who are reported to experience anxiety and/or depressive symptoms above a clinical cutoff will be randomly allocated to a CBM-I intervention or a waitlist control group. Children in the intervention group will undertake eight sessions online on a home device which trains them to interpret ambiguous information more positively or neutrally. Anxiety and depressive symptoms, and interpretation bias will be assessed before and after the intervention/waitlist period. Compared to the waitlist control group, we expect that the intervention group will report fewer symptoms and biases following the intervention/wait period and these gains will be maintained at one month follow up. We will also examine whether the intervention is enjoyable, useful, and easy to use among participants in the intervention group. This project is significant as it will evaluate the first CBM-I intervention which targets both anxiety and depressive symptoms in children and has been co-designed in consultation with children parents and clinicians. If the intervention is found to be effective and acceptable, it has potential to be used during a waitlist for standard care (e.g., Cognitive Behavioural Therapy (CBT)).
Interventions
This project aims to evaluate the efficacy of a cognitive bias modification of interpretations (CBM-I) intervention for children aged 8 to 10 years old with anxiety and/or depressive symptoms. We aim to evaluate its effectiveness versus a waitlist control group at post-intervention and after a one month follow up. Participants allocated to the intervention will receive the CBM-I intervention delivered in an online format. Access to the intervention will be password-protected on a website. Participants will complete the intervention on personal devices (e.g. computer, tablet, phone) within their own homes. The intervention has been specifically designed for children by a team of psychologists, researchers, user experience designers and software developers at the Black Dog Institute with co-design input from lived experience children, parents and mental health professionals. The intervention will involve 8, 10-15 minute sequential sessions four times per week over two weeks (up to three weeks). On completion of a session, the next session is only available for completion on the following day. The intervention is designed to encourage positive or benign interpretations of ambiguous situations and is based on similar tasks used by members of the project team. During every trial, children will be presented with a short 2-3 sentence scenario describing an uncertain situation that might happen to them. Children will be asked to imagine the scenario as happening to themselves as vividly as possible. Each scenario will be followed by two options, one describing a positive or benign outcome, and the other presenting a negative outcome. Children will be asked to read the scenario and two possible outcomes and then choose one of the outcomes. The scenario will then disappear from the screen and will be replaced with feedback on their choice that reinforces the positive/benign interpretation. Each session will contain 15 training scenarios (total 120 scenarios). In addition to the training trials, children will be presented with short pieces of narrative in between trials. The inclusion of the narrative is designed to promote engagement in the intervention by providing additional context to the scenarios, which was identified as important during the co-design process. All scenarios, narrative, response options, and feedback will be presented as text. A proportion of the scenarios (approximately 3-4 per session) will be accompanied by an image. The images are not designed to enhance the scenarios or intervention, but rather to increase engagement in the online program. The scenarios used in the intervention are matched to anxiety and depressive concerns commonly experienced by children (e.g., generalised concerns, social concerns, separation concerns and depressive concerns) and adapted from previous materials. To ensure relevance and matching of training content to children’s concerns, 40% of the scenarios will be matched to the child’s primary concern. Primary concerns will be identified based on a basic algorithm of subscale scores on the symptom questionnaire measures. Participants will receive points for “correct” responses (i.e., selection of the positive/benign option) and no points for “incorrect” responses (i.e., negative option). These points can be redeemed for illustrative icons within the digital program (e.g., medals, trophies or ribbons). Participants will also receive rewards as they progress through the program. The rewards will be set up by parents and children at the start of the intervention and delivered by parents. Participants allocated to the intervention will receive a weekly email check in to assist with session scheduling and can opt to receive a phone call with a researcher to answer questions about the program and assist with session scheduling. No additional contact with participants will be made, except if risk management phone calls or technical support for the intervention is required. For participants allocated to the intervention, the study will also collect research data associated with their engagement and use of the intervention. This trial will collect the following usage data from the intervention: number of sessions completed and individual responses to training activities.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Aged between 8 to 10 years (i.e., Grade 2 to 5) (parent-report) 2. Located in Australia (parent-report) 3. Reporting moderate levels of anxiety or depressive symptoms (as determined by a parent-report measure on the anxiety symptom subscale and depressive symptom subscale of the RCADS-25; t-score greater than or equal to 65 and an interference score greater than or equal to 1). 4. The child is fluent in English and is able to independently read and answer questions in English at Grade 2 level (to ensure comprehension of content) (parent-report) 5. Own or have access to an internet-enabled device (parent-report) 6. Have a parent or guardian who can provide consent for participation
Exclusion criteria
1. Experiencing life-threatening suicidal ideation and/or had serious suicidal ideation in the last month (parent-report) 2. Have a diagnosis of an organic brain injury, psychosis, severe developmental disability, vision impairment or physical disability that would prevent them using a computer (parent-report) 3. Fail to satisfy any of the inclusion criteria.