None listed
Conditions
Brief summary
Childhood anxiety is associated with long-term consequences including development of mood disorders if not treated early. However, literature shows that young children do not receive timely interventions due to long waiting lists, a shortage of psychologists and inability to complete interventions that are between 9-20 sessions, due to their parents’ other commitments. For that reason, this study proposes to test the effectiveness, acceptability and practicality of a 6-session anxiety intervention developed for children aged 4-7 years old presenting with anxiety. Cognitive Behavioral Therapy (CBT) is the main non-pharmacological intervention used in the treatment of anxiety. CBT is a talking-based therapy, which helps people explore and manage unhelpful thoughts in order to reduce distressing emotions or problematic behaviours. While often recommended, CBT alone may not be effective in treating anxiety and is not developmentally appropriate for younger children. Thus, the proposed study will use a developmentally appropriate intervention that combines modified CBT and sensory modulation. Sensory modulation is a clinical intervention that uses sensory-based strategies to help people regulate their emotions. The study will use a multiple baseline single case experimental design. Eight candidates meeting the inclusion criteria will be admitted into the study. Two therapists will each deliver the intervention with four children and their families (N=8). Firstly, two of the children will receive the intervention during a pilot phase. Then six children will receive the intervention during the study phase, where the intervention will be delivered in a staggered fashion. Data, including the levels of each child’s anxiety and functioning, will be collected before the intervention, during the intervention and one-month post intervention. Subjective feedback will be gathered from participants and therapists to determine the practicality and acceptability of the intervention.
Interventions
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 understa
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 covered from session one to session six and encourages the child and the family to continue using the skills taught. Every session comes with a home task that the child and parent will have to complete at home. The home task will be reviewed at the beginning of every new session. Each session will be evaluated using outcome scales to make sure that the treatment is progressing as intended. Participants will be randomly allocated to one of 3 baseline periods i.e. 3 weeks baseline period, 4 week baseline period and 5 week baseline period. All 6 CBT sessions will be delivered at Birthright Child and Family Care Trust in Napier. Each child will attend the six sessions with his/her parents/guardians. The sessions will be delivered by a therapist face to face. Each session will be 90 minutes long. Feedback Informed Treatments ( i.e. outcome rating scale and sessions rating scale) measures will be used to monitor how the treatment will be progressing. These forms will be administered at the beginning and end of each session. The parent and the child will complete these forms. The forms take about 5 minutes to complete. The home task takes about 10 minutes. The home tasks are in the intervention manual and will be given to the family at the end of each session. The manual is based on the ‘Coping Kiwi’ manual for anxiety (Girling-Butcher, 2002) and literature on sensory modulation. The main authors of the sensory modulation literature are American occupational therapists including Tina Champagne (2010).
Sponsors
Tafadzwa Mavhunga
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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. • 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.
Exclusion criteria
• Children with co-morbid diagnoses of Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiance disorder (ODD) and Psychosis. • Children with Intellectual Disability. • Children with a history of significant trauma with Post traumatic stress disorder (PTSD) or sexual abuse. • Children who are on anti-anxiety medication or other psychiatric medications. • Children who are extremely unwell/anxious such that they cannot wait for up to 8 weeks to be seen. • Children who are currently receiving psychotherapy or other psychological treatment for their anxiety. • Children with attachment or reactive attachment disorder.
Outcome results
None listed