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Trial registered on ANZCTR


Registration number
ACTRN12619000016134
Ethics application status
Approved
Date submitted
29/12/2018
Date registered
9/01/2019
Date last updated
26/07/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ready to Eat: Home-based behavioural intervention to help children progress from tube to oral feeding
Scientific title
Ready to Eat: Home-based behaviour analytic intervention to transition children from tube to oral feeding
Secondary ID [1] 296715 0
Nil known
Universal Trial Number (UTN)
U1111-1226-0354
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tube depedency 310892 0
Food refusal 310893 0
Paediatric feeding disorder 310894 0
Avoidant Restrictive Food Intake Disorder 310895 0
Condition category
Condition code
Diet and Nutrition 309564 309564 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural intervention provided face-to-face in homes by a Registered Psychologist and Board Certified Behavior Analyst (BCBA).

Waitlist-control:
For waitlist-control children, the psychologist will instruct caregivers to continue oral feeding attempts as usual, and the psychologist will conduct meal observations every two months. Meal observations will generally be conducted by video call or review of a video sample provided by the caregiver. Data will be collected regarding primary outcomes. Children will continue to access available DHB services (e.g., feeding groups), and we will maintain contact with health professionals to determine continued eligibility.

Pre-evaluation:
1) Feeding difficulties interview (FDI). The structured interview will be completed with caregivers. Consent will be gained to access relevant paediatric reports to identify previous and current medical diagnoses. Specific information will be obtained regarding foods or drinks accepted currently or historically, as well as caregiver responses to challenging behaviours. The caregiver will select an initial group of four target foods.
2) Pediatric Inventory for Parents. This self-report questionnaire has been considered well established at assessing family functioning in the context of chronic childhood medical problems. The questionnaire will also be administered following treatment.
3) Brief meal observation. To obtain true baseline data and plan assessment conditions, the caregiver will be asked to run a brief mealtime (up to 15 min) with the child, using the initial group of foods.

Assessment:
Up to 3-5 hours, over 6 sessions of 30 minutes each. To be completed over consecutive days within one week.

The experimental assessment will be lead by the psychologist with the caregiver also participating at the table. This assessment phase will take place within regular mealtimes (i.e., lunch, dinner), at least 1.5-2 hours from the child’s last meal or tube feed.

Assessment will involve a standardized schedule of food presentations with the target food group (i.e., once every 30 seconds), using the target food group. Each assessment meal will last a maximum duration of 30 min, or may end earlier if the child consumes the entire food portion available. If a child accepts food during, praise will be provided by the CI or caregiver. After 15-seconds, the child will be asked to open their mouth (‘show me’) to check if the food has been swallowed. If the child’s mouth is clean, praise is provided. If the child’s mouth is not clean, they will be instructed to ‘swallow’ and no further bites will be presented until a mouth clean is observed.

We will evaluate a series of 5-min conditions relevant to feeding using Functional Analysis methods (Piazza et al., 2003), based on information the caregiver provided during the interview. This analysis will involve comparing the situation/s reported to be successful (e.g., presenting a preferred food) with the situation/s reported to be unsuccessful (e.g., presenting novel foods, and negotiating with the child upon refusal to eat).

Further assessment conditions (Antecedent analysis) will involve evaluating specific properties of food, drink or feeding method that the caregiver reported to influence eating (Leadley, 2018).

Antecedent Analysis conditions will generally involve testing at least one of the following:
Volume: Smaller bite sizes (e.g., pea-size, dipped spoon, empty spoon)
Texture: Smoother textures (e.g., mashed, chopped, puree)
Feeding methods: Changing utensils or comparing adult- versus self-feeding

Behavioural data across assessment conditions will be compared. The conditions that show the most differentiation (e.g., where challenging behavior is more likely, where food acceptance is more likely) will inform the child’s treatment protocol.

Treatment: Between 5 - 10 hours, spread across mealtimes, and over consecutive days within a two -week period. Treatment sessions will be similar to assessment (up to 30 minutes, in the child’s regular mealtimes).

Based on assessment results and input from caregiver and health professionals, treatment could involve the following
1. Antecedent-based interventions: Modifications to food properties or feeding methods, working towards the child's goal. For example, starting with small bite sizes that slowly increase, starting with the adult feeding the child, progressing to self-feeding.

2. Teaching oral-motor skills: If oral-motor deficits are identified in assessment, teaching procedures will be incorporated to teach these skills in consultation with the child's speech language therapist (e.g., teaching lip closure)

3. Reinforcement-based interventions: Providing a preferred activity, food, or escape, upon the child accepting or consuming the food.

4. Extinction-based intervention: If no further interventions are effective, separate caregiver consent will be obtained to implement nonremoval of the spoon or food. In this procedure, the food or spoon is kept in position until the child accepts it, up to a maximum of 30 minutes.

Caregiver training and implementation:

Up to 2 hours for training, then 1-2 hours per week of monitoring.

Upon stable child progress, the caregiver/parent will be trained to implement their child's treatment plan. Training will be conducted by the psychologist and will involve progressive steps including review of the written protocol, role play, and feedback. Upon reaching an accuracy criterion, caregivers/parents will be asked to run as many meals as possible, with psychologist supervision reducing. The psychologist will visit weekly, then fortnightly, with phone or text communication between.

The caregiver implementation phase will continue until tube feeding ceases, or at six months from admission.

Follow-up:

One hour visits at 1,3,6, and 12 months from the end of the study. Follow-up visits will involve a meal observation and collection of primary outcome data.
Intervention code [1] 313215 0
Behaviour
Intervention code [2] 313278 0
Treatment: Other
Comparator / control treatment
Waitlist control group. The waitlist control group will be offered the intervention after a 6-month period (i.e, when the initial intervention group have completed treatment and are in follow-up). A minimum of three meal observations (once per two months) must have been completed during the waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 318521 0
Direct observation of food acceptance

Defined as the child opening their mouth and accepting the entire bolus of food or drink

The psychologist will use the Countee smart phone application to record behavioural data. Each button is assigned either a participant behaviour (e.g., acceptance, mouth
clean) or the caregivers’ behaviour (e.g., starting the trial by presenting the food).
Timepoint [1] 318521 0
Pre-, post-treatment, and follow-up meal implemented by the caregiver for a duration of 15-minutes.

Pre-treatment (baseline) will be conducted for all participants prior to randomization.
Post-treatment will be the final caregiver-implemented meal prior to study completion
Follow-up will be the last follow-up visit conducted at 12 months from the end of the study

Primary outcome [2] 318522 0
Oral intake

Oral intake will be measured in grams consumed, calculated as the pre-meal weight minus the post-meal weight. Recorded by the psychologist or caregiver using a standard kitchen scale, and recorded on a daily tracking sheet.
Timepoint [2] 318522 0
Pre-treatment (baseline) will be conducted for all participants prior to randomization.
Post-treatment will be the final home visit prior to study completion
Follow-up will be the last follow-up visit conducted at 12 months from the end of the study
Primary outcome [3] 318523 0
Tube intake

Tube intake will be measured in ml from tube feeding equipment (e.g., feeding bag with measures or syringe) and summarized as the percentage of daily kilocalorie requirements (as per dietitian calculations). Recorded by the caregiver on a daily tracking sheet.
Timepoint [3] 318523 0
Pre-treatment (baseline) will be conducted for all participants prior to randomization.
Post-treatment will be the final home visit prior to study completion
Follow-up will be the last follow-up visit conducted at 12 months from the end of the study
Secondary outcome [1] 365230 0
Direct observation of mealtime problem behaviour

Defined as turning the head away from the spoon and/or pushing away the spoon or feeder’s hand during food presentation, expelling foods (spitting food out), crying, or negative vocalisations. Further specific responses may be added for an individual child.

The psychologist will use the Countee smart phone application to record behavioural data. Each button is assigned either a participant behaviour (e.g., acceptance, mouth
clean) or the caregivers’ behaviour (e.g., starting the trial by presenting the food).
Timepoint [1] 365230 0

Pre-, post-treatment, and follow-up meal implemented by the caregiver for a duration of 15-minutes.

Pre-treatment (baseline) will be conducted for all participants prior to randomization.
Post-treatment will be the final caregiver-implemented meal prior to study completion
Follow-up will be the last follow-up visit conducted at 12 months from the end of the study

Secondary outcome [2] 365231 0
Body weight of the child

Measured by the psychologist using a portable scale
Timepoint [2] 365231 0
Pre-treatment (baseline) will be conducted for all participants prior to randomization.
Post-treatment will be the final home visit prior to study completion
Follow-up will be the last follow-up visit conducted at 12 months from the end of the study
Secondary outcome [3] 365232 0
Caregiver stress

Measured by the Peadiatric Inventory for Parents (PIP, Streisand, Braniecki, Tercyak & Kazak, 2001)
Timepoint [3] 365232 0
Pre-treatment (baseline) will be conducted for all participants prior to randomization.
Post-treatment will be the final home visit prior to study completion
Follow-up will be the last follow-up visit conducted at 12 months from the end of the study
Secondary outcome [4] 365233 0
Treatment satisfaction survey specific to children with tube dependency. Survey developed as part of previous pilot study and document is attached. A simplified survey developed for this study will also be administered to involved health professionals.
Timepoint [4] 365233 0
Post-treatment

Satisfaction surveys will be administered to caregivers at the final home visit, and to health professionals during the final week of the child's study participation.
Secondary outcome [5] 365477 0
Mouth Clean: Directly observed measure of food consumption

Defined as no food larger than a pea visible in the child’s mouth 15-s following acceptance. Not scored if absence of food was owing to expulsion

The psychologist will use the Countee smart phone application to record behavioural data. Each button is assigned either a participant behaviour (e.g., acceptance, mouth
clean) or the caregivers’ behaviour (e.g., starting the trial by presenting the food).
Timepoint [5] 365477 0
Pre-, post-treatment, and follow-up meal implemented by the caregiver for a duration of 15-minutes.

Pre-treatment (baseline) will be conducted for all participants prior to randomization.
Post-treatment will be the final caregiver-implemented meal prior to study completion
Follow-up will be the last follow-up visit conducted at 12 months from the end of the study


Eligibility
Key inclusion criteria
Participants will be recruited primarily within the Waitmata DHB area, followed by other DHB areas if required. We will recruit participants via contact with health professionals within the DHB, including paediatricians, dietitians, and speech language therapists. Children will be included in the study if they meet the following criteria, supported by the Evaluation of Readiness Tool developed by the Clinical Network for Peadiatric Tube Feeding

- Aged between 1 year and 14 years old and reside within the Waitemata DHB area
- Living at home or in a long-term care placement with a primary caregiver that is available to be present for mealtime sessions
- Dependent on tube feeding for all or partial nutritional needs for at least six months.
- Confirmation from a paediatrician with regards to :
o Stability or resolution of the original medical problem contributing to the initiation of tube feeding
o No pending medical interventions (e.g., surgery) that could affect feeding ability
o Absence of anatomic or functional impairment precluding safe oral feeding
- Confirmation from a Speech Language Therapist with regards to:
o Safe liquid swallow
- The child and their main caregiver are able to be available for the intensive assessment and treatment period (Up to 5 days per week, 1 to 2 weeks), and ongoing visits (weekly to bi-weekly, up to six months)
- The family do not identify any current barriers or other commitments that would prevent them running oral meals in the longer-term (e.g., 4-5 meals per day). If barriers are identified, the family consent to working with appropriate services concurrent with entry to the study (e.g., respite care for a younger sibling) or making adjustments (e.g., taking time off work)
- If the child is in school, there is agreement for the child to not attend for the intensive period (2 weeks), or the initial study phases will be scheduled during school holidays.
Minimum age
1 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they do not meet inclusion criteria as listed above. In addition, a waitlist-control participant will be excluded if the caregiver chooses to access an alternative intervention beyond standard care (e.g., a private intensive tube weaning programme)

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In addition to the waitlist-control, we will utilise single-case design methods, where each participant will also serve as their own control. Repeated measurement of target behaviours will occur throughout study phases. Single-case design methods are important in the field of behaviour analysis for measuring the clinical progress of each individual child, and guiding treatment decision-making (Kazdin, 2011). To demonstrate further control of intervention procedures, we will evaluate performance across participants using a multiple probe design.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A power analysis based on the results of the previous pilot study has informed the target sample size. Assuming a significance level of 0.05 and 80% power it is estimated that a sample of at least 8 children, (4 in each group), would be required to detect a similar effect on oral food intake (i.e., effect size of 2.13 to 2.49; Taylor et al., In press). We aim to recruit a total of 10 children during this study period.

We will calculate the change from pre- to post-treatment, and pre-treatment to follow-up for each study participant. Pre-treatment will consist of data collected during the initial baseline visit, and post-treatment will consist of data collected at study completion. Follow-up will consist of data collected at the 12-month visit. We will then compare the change scores between the waitlist-control and intervention group for each outcome. Data analysis will be carried out using SPSS.

We will summarize caregiver treatment fidelity and treatment satisfaction across participants.

For single-case design data, we will use visual analysis of all available data (e.g., repeated measures of each primary outcome). We will compare changes between baseline and intervention for individual participants and varied treatment procedures. Data will be graphed using Prism software.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21148 0
New Zealand
State/province [1] 21148 0
Auckland, WDHB area

Funding & Sponsors
Funding source category [1] 301295 0
Commercial sector/Industry
Name [1] 301295 0
AMP Scholarships
Address [1] 301295 0
29 Customs St W
Auckland, 1010
Country [1] 301295 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Psychology
Building 302
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 301220 0
None
Name [1] 301220 0
Address [1] 301220 0
Country [1] 301220 0
Other collaborator category [1] 280478 0
Hospital
Name [1] 280478 0
Waitemata District Health Board
Address [1] 280478 0
Waitakere Hospital
Private Bag 93-115
Lincoln Road
Henderson
AUCKLAND 0650
Country [1] 280478 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302036 0
Health and Disability Ethics Committee
Ethics committee address [1] 302036 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302036 0
New Zealand
Date submitted for ethics approval [1] 302036 0
21/01/2019
Approval date [1] 302036 0
11/04/2019
Ethics approval number [1] 302036 0

Summary
Brief summary
Behavioural interventions have strong research evidence in the treatment of childhood feeding disorders, particularly for tube dependency. However, treatment centres are not widely accessible, and there are currently no publically funded behavioural services available in New Zealand. A recent pilot study provided very encouraging preliminary evidence for home-based treatment, with the close involvement of caregivers and health professionals.

This randomised controlled trial seeks to extend previous research, and will be the first controlled study to investigate home-based behavioural treatment for children with tube dependency. In addition, the use the single-case design methodology presents a novel approach. The behavioural, nutritional, and social outcomes of this project will help to demonstrate the effectiveness of behavioural treatment outside of controlled settings.
Trial website
Trial related presentations / publications
Public notes
Lay summary information available online

https://www.facebook.com/AMPScholarships/videos/372454756838508/

http://healthcentral.nz/scholarship-realises-dream-of-helping-kids-with-feeding-difficulties/

Contacts
Principal investigator
Name 88922 0
Dr Sarah Leadley
Address 88922 0
School of Psychology
Building 302
Private Bag 92019
Auckland 1142
Country 88922 0
New Zealand
Phone 88922 0
+64 279313551
Fax 88922 0
Email 88922 0
s.leadley@auckland.ac.nz
Contact person for public queries
Name 88923 0
Dr Sarah Leadley
Address 88923 0
School of Psychology
Building 302
Private Bag 92019
Auckland 1142
Country 88923 0
New Zealand
Phone 88923 0
+64 279313551
Fax 88923 0
Email 88923 0
s.leadley@auckland.ac.nz
Contact person for scientific queries
Name 88924 0
Dr Sarah Leadley
Address 88924 0
School of Psychology
Building 302
Private Bag 92019
Auckland 1142
Country 88924 0
New Zealand
Phone 88924 0
+64 279313551
Fax 88924 0
Email 88924 0
s.leadley@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Other
'Other' documents specified
Satisfaction survey
How or where can supporting documents be obtained?
Type [1] 974 0
Other
Citation [1] 974 0
Link [1] 974 0
Email [1] 974 0
Other [1] 974 0
Treatment satisfaction survey
Summary results
No Results