Category
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Primary study
Registry of Trials»ANZCTR
Year
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2012
INTERVENTION: The intervention includes Cognitive Behaviour Therapy (CBT) anxiety management strategies delivered to parents, and includes: psychoeducation, relaxation training, recognition of the physiological symptoms of anxiety, cognitive strategies of coping self‐talk and cognitive restructuring, graded exposure, problem solving, and self‐reinforcement. The sessions also teach parenting strategies to empower parents to help their children implement anxiety management skills. The intervention consists of the parent program of BRAVE‐ONLINE and will include six, one‐hour online sessions for parents, completed over a 10‐week period. Booster sessions are completed at one‐ and three‐months following treatment. The parent program of BRAVE‐ONLINE was originally developed for children aged from eight years, and their parents. For the purposes of this pilot study, handouts were provided to parents in order to make the examples and situations presented in the program, age appropriate for preschool children. Sessions are designed to be engaging and interactive. Eye‐catching graphics, sounds, games and quizzes are used to maintain interest. Information is presented through interactive exercises and followed by quizzes that check for correct understanding and provide personalized corrective or positive feedback through pop‐up messages. The content of the intervention is suitable for the parents of school aged children and the supplementary handouts provide age‐appropriate scenarios, examples, and activities for preschool aged children. Examples of scenarios presented include starting preschool or kindergarten, or meeting new children at playgroup. The program is (minimally) therapist‐assisted, rather than self‐help. Each family is assigned an online therapist (BRAVE Trainer) who monitors their progress through the program and provides brief email feedback following each session. At no stage do any participants have face‐to‐face contact with their therapist and all other contact (i.e., email or phone) is minimal. Clinician contact is restricted to brief, weekly emails. Most other contact with the ‘online therapist’ is computer generated. Client responses to all session and homework activities are stored in an administrator section of the program and can be viewed by the therapist to guide the content of the weekly email. In addition, automated computer‐generated emails are sent on behalf of the online therapist to congratulate participants for completion of sessions and personalized emails are sent to provide feedback about responses to quiz tasks. Personalized automated reminder emails are sent to advise when the next session is available for completion, or to provide prompts if not completed by the due date. The wait list control condition will complete the pre‐treatment assessment and will then be reassessed after 10‐weeks. After this point they will be offered treatment by the research team. CONDITION: Anxiety in preschool aged children INCLUSION CRITERIA: Participants (of any age) will be included in the study if they have pre‐school aged children (3‐5 years at the time of intake) who meet DSM‐IV criteria for a primary diagnosis of an anxiety disorder with a clinical severity rating (CSR) of at least 4 (on a 0‐8 scale). Comorbidity with externalising disorders will be permissible as long as anxiety is considered primary. Families must have access to a suitable computer and the internet, and be willing to participate in either condition. PRIMARY OUTCOME: Overall adaptive functioning using the Children's Global Assessment Scale (CGAS: Schaffer et al., 1983). The CGAS provides a single global rating of functioning, assigned to the child by the independent, interviewing clinician, on a scale of 0 to 100, where lower scores indicate poorer functioning. A rating is given based on the child's most impaired level of general functioning for the specified time period by selecting the lowest level which describes his/her functioning on a hypothetical continuum of health‐illness, benchmarked against anchor points in a descriptive glossary. The primary outcome measure includes "blind", independent clinical diagnostic interviews for anxiety disorders and clinician severity ratings of diagnoses using the Anxiety Disorders Interview Schedule for DSM‐IV: Parent version (ADIS‐P) SECONDARY OUTCOME: Assessment of parental levels of depression, anxiety and stress will be measured using the Depression, Anxiety and Stress Scale (DASS‐21, Lovibond & Lovibond, 1995) Assessment of parenting style will be measured using the Egna Minnen Betraffande Uppfostran (EMBU‐P, Castro et al., 1996) Child anxiety will be measured using the Pre‐school Anxiety Scale (PAS, Spence et al., 2001) Internalizing problems using the internalising scale of the Child Behaviour Checklist for Ages 1.5 ‐ 5 (Achenbach) Parental satisfaction with the program will be measured using the Parent Satisfaction Questionnaire (PSQ) The overall functioning of the parent will be measured using the Overall Functioning measure (OF) Therapy compliance measures, computer generated: number of sessions completed; frequency of sessions; number and quality of completed homework assignments; number and quality of session activities completed; time spent on sessions.
Epistemonikos ID: 70300ec9d8108bb239f6cc9d918795ca824cde63
First added on: Aug 25, 2024