The effectiveness, acceptability and practicality of a combination of talking therapy and sensory based intervention for children aged 4-7 years old presenting with anxiety.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: The intervention uses principles of cognitive behaviour therapy (CBT) and sensory modulation. The intervention will be delivered to the child and their parent(s) over a 6‐week period (one session per week). Before the study, two therapists will be trained how to deliver the intervention by the researcher, following an intervention manual. The 6 sessions are as follows. The first session introduces the intervention to the child and the parent(s). The session aims to improve the parents understanding of anxiety, how anxiety affects children’s function, how anxiety affects family life and strategies that are helpful to manage anxiety. The second session teaches the child how to identify signs of anxiety in themselves. It also teaches the parents how to notice the physical signs and behaviours of anxiety in their child. The third session is a continuation of session two and focusses on making the connections between unhelpful thoughts and what they feel in their body. Session one to three are based on cognitive behaviour therapy. Session four teaches the child relaxation techniques using sensory based strategies (for example listening to music, getting a hand massage, doing a physical activity, deep breathing exercises, using different smells for relaxation etc). Parents will be encouraged to identify activities that calm down their child when they are worried. The child and the parent will be taught how to use these activities in times of distress to help the child to calm down and relax. Session five teaches the child and the parents’ ways of ensuring that the calming activities are practiced every day and become part of the child’s daily routine. Session six is a consolidation and celebration session. This session summarises all the materials CONDITION: Anxiety; ; Anxiety Mental Health ‐ Anxiety PRIMARY OUTCOME: Change in anxiety. This is a composite anxiety outcome.; ; The outcome will be assessed by assessing the child's level of anxiety at different points in the study using the following assessment tools: ; 1. Child Anxiety Life Interference Scale ( Parent form ); 2. Child Anxiety Life Interference Scale ( Child form ); 3. Child Anxiety Life Interference Scale Pre School Version; 4. Preschool Anxiety Scale Revised ( PAS‐R); 5. School Anxiety Scale Teacher Report form ; ; These tools will be administered at 5 points; on entry into study, during baseline period, after 3 weeks of intervention, after week 6 of intervention and after one month post intervention completion. The forms will be completed by the parent and the child. ; A clinical psychologist will assess the child's level of anxiety on entry into study, at completion of study and one month post intervention completion. The clinical psychologist will assess if the child's anxiety has shifted as a result of the intervention ( i.e. whether the child still meets criteria for a diagnosis of anxiety or not). ; The parents will track 3 behaviours that they are concerned about through the study using a tracking diary specifically designed for the study.[The study has 5 timepoints; on entry into study, during baseline period, after 3 weeks of intervention, after week 6 of intervention and after one month post intervention. ] ; ; This outcome will be assessed by study specific questionnaire that will be completed by the therapists at the end of the study. ; INCLUSION CRITERIA: • Children with at least one parent who will be willing to participate in the intervention program. • Children aged 4‐7 years, both boys and girls. • Children with parents who will not travel within 18 weeks of commencing the study such that it will affect their therapy attendance. • Parents and child able to engage in conversational English. SECONDARY OUTCOME: Acceptability of the intervention by the parents [This outcome will be assessed by the parents by completing a study specific questionnaire at the end of the study. ] Acceptability of the intervention by therapists ; [1 week post intervention completion] Child's functioning [This outcome will be assessed by reviewing the behaviour tracking diary that will be completed by the parents through out the study. The parents will track 3 behaviours they are concerned about using a study specific behaviour tracking diary. ] Practicality of the intervention in New Zealand settings ; This outcome will be assessed by reviewing the responses by parents and therapists to specific questions about practicality of the intervention in the study specific questionnaire they will complete at the end of the study. This is the same questionnaire that has questions about acceptability of the intervention. [1 week post intervention completion] • Children who meet the criteria for at least one anxiety disorder, which is confirmed during a clinical interview and supported by clinical documentation from their psychiatrist, paediatrician, clinical psychologist or GP.
Epistemonikos ID: bb308a4aa84fdafcb5e929c5a6bbff42f0f8d3eb
First added on: Aug 25, 2024