Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000368831
Ethics application status
Approved
Date submitted
2/02/2021
Date registered
31/03/2021
Date last updated
4/03/2022
Date data sharing statement initially provided
31/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
The effectiveness, acceptability and practicality of a Cognitive Behaviour Therapy (CBT) -Sensory Modulation (SM) intervention for children aged 4-7 years old presenting with anxiety.
Secondary ID [1] 303315 0
Nil known
Universal Trial Number (UTN)
U1111-1240-5796
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 320545 0
Condition category
Condition code
Mental Health 318399 318399 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 319621 0
Treatment: Other
Intervention code [2] 319872 0
Behaviour
Comparator / control treatment
The study uses single case experimental design- the participant is their own control.

Participants will receive no treatment during the baseline period.
Control group
Active

Outcomes
Primary outcome [1] 326379 0
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.
Timepoint [1] 326379 0
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.
Secondary outcome [1] 391263 0
Acceptability of the intervention by therapists

This outcome will be assessed by study specific questionnaire that will be completed by the therapists at the end of the study.
Timepoint [1] 391263 0
1 week post intervention completion
Secondary outcome [2] 391264 0
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.
Timepoint [2] 391264 0
1 week post intervention completion
Secondary outcome [3] 392426 0
Acceptability of the intervention by the parents
Timepoint [3] 392426 0
This outcome will be assessed by the parents by completing a study specific questionnaire at the end of the study.
Secondary outcome [4] 392427 0
Child's functioning
Timepoint [4] 392427 0
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.

Eligibility
Key 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.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The random baseline allocations will be preset before the study . This information is initially known to the researcher. The therapists will only know the baseline periods when the participants enters the study and is allocated to them.
Partipants 1 and Participant 2 will have a 3 week baseline during the pilot phase.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Using Microsoft excel application, three groups ( 3 week, 4 week, 5 week) will created against 6 participants ( participant3, participant, 4 participant 5, participant 6, participant 7, participant 8)
Using the random number function and and a random allocation formula, participants will be randomly and evenly allocated into one of these conditions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single case design experiment

Participants are their own control. On entry into study, participants will go through a baseline period to establish their baseline levels of anxiety. This is the control period. During the baseline period the participants do not receive any intervention.
At the end of the baseline period, the intervention phase begins.
Analysis of the results focuses on the differences in scores between the baseline period and the intervention period.
Participants will be randomised to one of three baseline periods ( 3 week baseline, 4 week baseline, 5 week baseline).
The random allocation to baseline periods will be done using the Microsoft excel random number function. Three groups will be created ( 3 weeks , 4 weeks and 5 weeks ) against participants ( participant 3, participant 4, participant 5, participant6, participant 7, Participant 8) in Microsoft excel application. A formula will be entered into excel to randomly and evenly allocate participants to one of these baseline periods.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1. Visual analysis of the scores during the baseline and intervention phase
2. Effect size calculation
3.The percentage of all non-overlapping data (PND) will be used to estimate the extent to which data from the treatment phase improves on and does not overlap with baseline data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
16/06/2021
Date of last participant enrolment
Anticipated
31/07/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
8
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 23421 0
New Zealand
State/province [1] 23421 0
Hawkes Bay

Funding & Sponsors
Funding source category [1] 307732 0
University
Name [1] 307732 0
Auckland University of Technology
Country [1] 307732 0
New Zealand
Funding source category [2] 308007 0
Other
Name [2] 308007 0
Hawkes Bay Medical Research Foundation
Country [2] 308007 0
New Zealand
Primary sponsor type
Individual
Name
Tafadzwa Mavhunga
Address
Auckland University of Technology
640 Great South Road,
Manukau, Auckland, 2104
Country
New Zealand
Secondary sponsor category [1] 308433 0
None
Name [1] 308433 0
Address [1] 308433 0
Country [1] 308433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307759 0
Northen A Health and Disability Ethics Commitees
Ethics committee address [1] 307759 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 307759 0
New Zealand
Date submitted for ethics approval [1] 307759 0
07/06/2020
Approval date [1] 307759 0
15/12/2020
Ethics approval number [1] 307759 0
20/NTA/165

Summary
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.
Trial website
Trial related presentations / publications
Public notes
This study is being completed for the attainment of a Doctor of Health Sciences degree. The principal investigator is a student at Auckland University of Technology in New Zealand. The student receives a small grant towards the study and an academic fees scholarship. The student has also received funding from Hawkes Bay Medical Research Foundation.

Contacts
Principal investigator
Name 108394 0
Mr Tafadzwa Mavhunga
Address 108394 0
Auckland University of Technology
640 Great South Road,
Manukau, Auckland, 2104
Country 108394 0
New Zealand
Phone 108394 0
+64 21756400
Fax 108394 0
Email 108394 0
[email protected]
Contact person for public queries
Name 108395 0
Mr Tafadzwa Mavhunga
Address 108395 0
Auckland University of Technology
640 Great South Road,
Manukau, Auckland, 2104
Country 108395 0
New Zealand
Phone 108395 0
+64 21756400
Fax 108395 0
Email 108395 0
[email protected]
Contact person for scientific queries
Name 108396 0
Mr Tafadzwa Mavhunga
Address 108396 0
Auckland University of Technology
640 Great South Road,
Manukau, Auckland, 2104
Country 108396 0
New Zealand
Phone 108396 0
+64 21756400
Fax 108396 0
Email 108396 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data will be de identified data
-age, gender, psychometric scores, anxiety levels and levels of functioning of participants will be shared in the final report in a form that will not identify the individual participants
When will data be available (start and end dates)?
The data will be available 1 year after the completion of the study and will not be available after 10 years or after the youngest participant turns 16.
Available to whom?
The findings of the study will:

-be shared with participants
-be able to be accessed by other people who may search for the study on the Auckland University of Technology thesis repository
-be shared with other professionals during presentation of results of the study after completion of the study
-be shared with other researchers who request the information
Available for what types of analyses?
Any purpose
How or where can data be obtained?
The data can be obtained by requesting it from the the principal investigator using the following e-mail address.

[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.