RecruitingACTRN12616001552471

Effectiveness of school group-based acceptance and commitment therapy for children with anxiety: a randomised controlled trial


Sponsor

Sydney Children's Hospital Network

Enrollment

130 participants

Start Date

Sep 28, 2016

Study Type

Interventional

Conditions

Summary

Acceptance and Commitment Therapy (ACT) is rapidly growing in its evidence base for treating a variety of psychological disorders, but it is in an early stage of research in children. At the Children's Hospital at Westmead, Department of Psychological Medicine, we have developed and evaluated the effectiveness of an ACT program (ProACTive) for children and young people with anxiety disorders in the world's first and largest randomised controlled trial in this area. Following its initial successful implementation and evaluation in a hospital clinic setting, this project aims to evaluate the feasibility and effectiveness of a school-delivered ACT program (ProACTive) for children and young people with anxiety disorders. The program aims to improve quality of life and to assist school students with an anxiety disorder to manage their symptoms so they don't have such a negative interference in their life. We plan to evaluate the program on a group -delivered basis in children aged 7-17 years (primary and high school versions). An RCT will be used to compare two groups (n=65 per group) who receive (1) ProACTive and 2) comparison wait list control group. Controls will be offered the program 10 weeks after recruitment and two assessments (see below) take place 10 weeks apart. The program runs 1 hour every week for 10 weeks and will be implemented by school counsellors trained in ProACTive. It involves learning skills (e.g. mindfulness, acceptance, distancing from thoughts/feelings/sensations, exposure therapy), to assist students manage their anxiety in such a way as they can get on with doing what's important and things they enjoy (i.e. leading a more rich, full and meaningful life). Parents will also be engaged in the program, but with less involvement, undergoing psychoeducation and skills training on 2 occasions: on initiation of treatment and exposure therapy sessions. Effectiveness To evaluate the effectiveness of the program, participants in the treatment group and their parents/guardian will be asked to complete some standardised questionnaires and a 30 minutes structured interview: (1) prior to (ii) immediately after and (iii) 6 months after participating in the program. These questionnaires will take approximately 20 minutes to complete and will assess students' level of anxiety, depressive mod symptoms and quality of life. Controls will be assessed on the same measures on 2 occasions 10 weeks apart, prior to receiving the same program. Feasibility School counsellors implementing the program will be asked to complete a feasibility questionnaire evaluating the ease of implementation and usefulness of resources The main aims are: 1) Evaluate the feasibility of implementing ProACTive in a school setting 2) Evaluate the effectiveness of delivering ProACTive in a school setting


Eligibility

Sex: Both males and femalesMin Age: 7 YearssMax Age: 17 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a therapy program called ProACTive — based on Acceptance and Commitment Therapy (ACT) — for children and teenagers with anxiety disorders, delivered in a school setting by school counsellors. The program runs for 10 weeks, one hour per week, and teaches skills like mindfulness, accepting difficult feelings, and taking action on what matters most. Researchers want to know if this program can reduce anxiety and improve quality of life when delivered in schools. You may be eligible if: - Your child is between 7 and 17 years old - Your child has been diagnosed with an anxiety disorder (e.g., social anxiety, generalised anxiety, OCD, panic disorder, or specific phobia) - A parent or caregiver is willing to attend two parent sessions - Your child can attend at least 80% of the weekly sessions You may NOT be eligible if: - Your child has a developmental or language delay of more than one year behind peers - Your child has psychosis, conduct disorder, or is actively suicidal - Your child has ADHD that is not well controlled - Your child has post-traumatic stress disorder (PTSD) - Your child has been on anxiety or antidepressant medication for less than 2 months Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Acceptance and Commitment Therapy group-based manualised therapy program delivered by school counsellors formally trained in Proactive, at the child's school, as 10 x 1 hour sessions over 10 weeks, in

Acceptance and Commitment Therapy group-based manualised therapy program delivered by school counsellors formally trained in Proactive, at the child's school, as 10 x 1 hour sessions over 10 weeks, involving up to 8 children. Parents will have limited involvement. They will receive 2 sessions of 1. 5 hours duration coinciding with session 2 and session 7. The first session will be run by the school counsellors (psychologists trained in ProACTive who will be implementing the groups, using a Powerpoint presentation prepared by the CI. The first session involves psychoeducation around anxiety, ACT, and the ProACTive program. Parents receive a manual containing the information being presented in more detail. They will also have the opportunity to ask any questions relevant to their child's treatment. particular focus will be on parenting a child with anxiety, and how to ensure the skills being taught are generalised.. The 2nd session in week 7 will be conducted by the 2 CIs using a webinar format where parents across the various schools can interact live. Specific focus will be on understanding the upcoming exposure in-session activities, and how to assist with generalisation. It will also be an opportunity to clarify any questions about the skills taught thus far, as well as trouble shooting generally issues that may be applicable across families. Parents will be asked to submit their questions prior to the webinar. The ACT program will involve the "Proactive" developed at The Children’s Hospital at Westmead, for children aged 7-11 years and 12-17 years, respectively. Groups will be run by 2 school counsellors who are psychologists formally trained in Proactive. Proactive has been empirically evaluated and found to be an effective treatment for children and young people with anxiety. This program incorporates all six ACT core therapeutic processes that target psychopathology including Acceptance, Being Present/Mindfulness, Valued directions, Committed Action, Self-as-context and Cognitive Defusion. Rather than focusing on symptom control, this program will concentrate on anxiety management via supporting children to identify what is important to them and get on with doing what they enjoy and is important to them, whilst encouraging acceptance of anxious thoughts and feelings that may arise in the process of doing so. Sessions involve Formal mindfulness practice is incorporated on commencement of each session. Psychoeducation (sessions 1and2) includes an adolescent-adapted explanation of the ACT model via metaphor and experiential learning approaches. Values cards support understanding of the concept of living a valued life(session2). Defusion (getting some distance from difficult internal experiences) is taught via metaphors and experiential exercises (session 3 onwards). Graded exposure is undertaken using the ACT model whereby the act of confronting the fear is an exercise designed to enhance psychological flexibility, while the therapeutic procedure is what is performed in the presence of the feared situation . Specifically, emphasis is placed on supporting mindful observation and acceptance of anxiety while faced with fear in order to foster committed action in line with self-identified values (from session 4 onwards). Finally, problem solving and social skills are incorporated to facilitate committed action. The skill of self-compassion is specifically addressed during acceptance psycho-education and in the final session where mindfulness activities using loving kindness are demonstrated.


Locations(1)

NSW, Australia

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ACTRN12616001552471