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Trial registered on ANZCTR


Registration number
ACTRN12614001127695
Ethics application status
Approved
Date submitted
9/10/2014
Date registered
23/10/2014
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Behavioural Assessment and Treatment to Transition Children from Tube Feeding to Oral Nutrition
Scientific title
For children dependent on enteral nutrition, can behavioural intervention lead to increases in acceptance of oral nutrition and associated nutritional outcomes
Secondary ID [1] 285471 0
Nil
Universal Trial Number (UTN)
U1111-1162-7353
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tube feeding dependency 293248 0
Condition category
Condition code
Diet and Nutrition 293517 293517 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1. Caregiver interviews and brief mealtime observation

Pediatric Feeding Assessment Interview. The structured interview will be completed with caregivers. The survey is designed to elicit information about potential antecedents and consequences that influence the child’s feeding behaviour. Consent will be gained to access relevant paediatric reports to identify previous and current medical diagnoses and oral motor skill. Specific details will be collected with regards to liquids/foods (oral stimuli) previously or currently accepted (antecedent dimensions), as well as caregiver responses to the child’s inappropriate mealtime behaviour (consequence dimensions).

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.

Preference assessment. An interview, The Reinforcement Assessment for Individuals with Severe Disabilities (RAISD) will be used to determine the preferences of a participant. This interview tool will be completed by a caregiver, or child where able. This interview provides information on useful reinforcers for the individual. We will then conduct a paired-stimulus preference assessment where we will record the participant’s frequency of approach to items when presented in varied pairs. The most preferred items and activities will be used during the assessment and treatment, and to develop rapport with the participant

Brief mealtime observation: A brief mealtime will be observed where the caregiver initially feeds the child under normal conditions, followed by structured conditions (e.g., presenting food every 30 sec)

Part 2. Experimental Assessment

Assessment to occur in a regularly scheduled mealtime. The researcher will present the child with food
or drink under a range of conditions (i.e., feeding method, volume of food). Assessment sessions will last for up to 30 min, and up to 6 sessions spread over a few mealtimes (e.g., 3 hours) may be required. Data will be collected with respect to acceptance of oral stimuli, as well as rates of mealtime problem behaviour. We will examine these assessment results to develop an initial treatment plan based on the conditions that resulted in consumption of food or drink, or lowered rates of problem behaviour (e.g., less screaming observed when a bottle is used instead of spoon).

Part 3. Experimental treatment evaluation

Intervention will initially be conducted by the researcher. Intervention will involve progressively altering properties of food, liquid, feeding method, or instructions, based on assessment results.
Treatment examples could include one or a combination of the following progressions:
- Volume (e.g., empty teaspoon to full teaspoon)
- Texture (e.g., puree to chopped fine food)
- Feeding method (e.g., baby bottle to a spoon)
- Food preference (e.g., blending non-preferred food with preferred food)
- Feeding-related instructions (e.g., instructions with high compliance to instructions with low compliance)

Progression of treatment (e.g., increasing volume or texture) will be determined based on directly observed behavioural criteria. Progression will occur following three consecutive sessions where a child's consumption (acceptance and mouth clean) is at or above 80%, and problem behaviour is at or below 20%.

Behavioural data, the child's weight, and volume of oral stimuli consumed will be shared with the child's Health Team to determine enteral nutrition reductions.

If initial treatments do not demonstrate clinically significant results (over three consecutive sessions - maximum one week), additional treatment components will be added the following week (provided consent is provided from caregiver and Health Team is consulted). These additional components could include:

(a) Reinforcement. We will use differential reinforcement procedures whereby we will provide reinforcement for consumption of the oral stimuli, whilst providing no reinforcement for any inappropriate behaviours. The items used as reinforcers for each child will be based on initial assessment. Following the consumption of the oral stimulus, we will provide access to the preferred food or item (for a period up to 15 s).
(b) Escape Extinction. The escape extinction method will be determined with caregiver and health team input, but will take either of the following forms if the oral stimulus is not accepted within 5-s.
- Nonremoval of the spoon – the oral stimulus will be held near the child’s mouth
- Physical guidance – gentle pressure will be applied the child’s jaw to allow the oral stimulus to be placed in the mouth

Intervention sessions will take place within regular mealtimes, for up to 30 min. The author will initially conduct intervention during at least 2 mealtimes per week. The author will continue to conduct the intervention at this frequency until stable treatment progress is achieved (e.g., the child progresses through at least two treatment levels). The timeframe to achieve stable treatment progress will vary by participant.

Part 4. Caregiver training and implementation of procedures

Caregivers will participate in training sessions, involving (a) review of written protocols, (b) observation of researcher led meals and data recording, (c) Role play of procedures, (d) Caregiver implementation under supervision. Data will be collected on the accuracy to which caregivers implement procedures. After meeting criterion, caregivers will be able to implement procedures with their child. At this stage it would be expected that the caregiver implements procedures during every oral feeding meal (e.g., 3 x 30 min meals per day). This would continue until the child meets their initial treatment goal (e.g., to eat an age-appropriate portion of pureed food), or up to 12 months.

Adherance to the intervention will be monitored by collecting 'Procedural Integrity' data. An independent observer will record whether each treatment component is implemented correctly or incorrectly for the researcher. The researcher would collect this data when the caregiver is implementing procedures (either in vivo or from video recording).

Treatment sessions will be continued in the manner above (e.g., either researcher- or caregiver-implemented) until the child reaches their treatment goal, or 12 months
Intervention code [1] 290406 0
Behaviour
Intervention code [2] 290432 0
Treatment: Other
Comparator / control treatment
None. This study involves single subject design whereby each participant will receive treatment based on their assessment results and best available research evidence.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293331 0
Consumption (acceptance and mouth clean) of oral stimuli (food or drink).

Directly observed behavioural measure.

Defined as:
Acceptance - Entire bolus of food or liquid accepted into child’s mouth within 5-s of presentation

Mouth Clean - No food larger than a pea visible in the child’s mouth 30-s following acceptance. Not scored if absence of food was owing to expulsion

The researcher will use ABC Data PRO to collect this data in real time It is a software application for handheld computers (e.g., IPhone touch) that is well suited for behavioural observation procedures. The application allows the observer to record up to nine events concurrently operating nine independent buttons on a touchscreen. 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] 293331 0
From the start of experimental assessment, and at each mealtime during researcher-implemented treatment. During caregiver-implemented treatment, these outcomes will be assessed at least weekly. Outcomes will be assessed in this manner until the study ends for the participant (when treatment goal is achieved or at 12 months)
Primary outcome [2] 293332 0
Inappropriate mealtime behaviour

Directly observed behavioural measure, recorded in the same manner as above (ABC Data Pro application)

Behaviours specific to individual child will be recorded, examples below.
Expulsion- emitting oral stimuli larger than the size of a pea out of the mouth

Gag - Retching by co-occurring movement of the stomach, chest, and mouth, with or without audible sound.
Timepoint [2] 293332 0
From the start of experimental assessment, and at each mealtime during researcher-implemented treatment. During caregiver-implemented treatment, this outcome will be assessed via a caregiver completed rating scale (Inappropriate behaviour rated as occurring 0-none, 1-some, or 2-lots, during the session).

Outcomes will be assessed in this manner until the study ends for the participant (when treatment goal is achieved or at 12 months)
Primary outcome [3] 293333 0
Volume (grams) of food or liquid consumed

Oral stimuli will be weighed prior to a session. Following the session, the weight of remaining oral stimuli (e.g., in bowl, tray, floor, bib) will be subtracted from pre-session weight to obtain volume consumed.
Timepoint [3] 293333 0
From the start of experimental assessment, and at each mealtime during researcher-and caregiver-implemented treatment. Volume consumed will be assessed in this manner until the study ends for the participant (when treatment goal is achieved or at 12 months)
Secondary outcome [1] 310801 0
Child weight

Using portable digital weighing scale prior to a meal at weekly-fortnightly intervals.
Timepoint [1] 310801 0
From the start of assessment and at every time where the researcher visits the home. Weekly from the start of experimental assessment, and bi-weekly when the caregiver implements the intervention. Child weight will be assessed in this manner until the study ends for the participant (when treatment goal is achieved or at 12 months)
Secondary outcome [2] 310802 0
Volume of enteral nutrition (tube feeding)
Timepoint [2] 310802 0
From start of treatment. Caregiver will record volume of daily enteral nutrition. Volume of enteral nutrition will be assessed in this manner until enteral nutrition is discontinued, or the study ends for the participant (when treatment goal is achieved or at 12 months)
Secondary outcome [3] 310803 0
Parental stress

Measured using Pediatric Inventory for Parents (PIP, Streisand, Braniecki, Tercyak & Kazak, 2001)
Timepoint [3] 310803 0
During Part 1: Caregiver interview stage, and when study ends for the participant (when treatment goal is achieved or at 12 months)

Eligibility
Key inclusion criteria
*Aged between 1 year and 16 years old and reside within the Auckland 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 enteral nutrition for at least six months. There may be a range in the degree of dependence and the scheduling of enteral nutrition (e.g., 50% of daily needs, feeding at night only)
*During the duration of enteral nutrition, previous attempts to eliminate enteral nutrition have been unsuccessful, not owing to any medical factors
*The support of professionals that are involved in the child’s health
*Confirmation from a paediatrician with regards to :
Stability or resolution of the original medical problem contributing to the initiation of enteral nutrition
No pending medical interventions (e.g., surgery) that could affect feeding ability
Absence of anatomic or functional impairment precluding safe oral feeding
Maintenance of clinically safe weight
*Confirmation from a Speech Language Therapist with regards to:
Safe liquid swallow
Refusal of age appropriate food in the two weeks prior to the study
Minimum age
1 Years
Maximum age
16 Years
Sex
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Single subject design, whereby each participant will serve as their own control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The single-subject design in this study will involve measurement of each participant's target behaviours on a continuous basis (e.g., acceptance of food or drink) during baseline, and treatment. An experimental effect will be demonstrated when the predicted performance of these dependent variables co-varies with manipulation of the independent variable. Visual analysis of each particpant's graphed treatment data will be used to evaluate treatment effectiveness.

Single-subject experimental designs (SSED) are methodological strategies based on time-series recording. Thus, the power of the analysis in a SSED depends on the number of observations per experimental condition and subject. The number of subjects in the study is only relevant to the generality of findings but not to the demonstration of intervention effects. If we adopt an approach to power analysis calculations combining both time-series recording and between-subject replication, the interrupted time-series analysis literature becomes relevant. An interrupted time-series design is analogous to an SSED with respect to power calculations. A recent analysis indicated that a sample size of 12 in a highly autocorrelated dataset would lead to a power above 0.80 assuming an effect size of 1 and equal pre- and postintervention time periods (based on 10,000 simulated datasets and a statistical significance level of 0.05; see Zhang et al., 2011 for details). Thus, we believe that the proposed sample size is adequate in the context of an SSED.

Zhang, F., Wagner, A. K., & Ross-Degnan, D. (2011). Simulation-based power calculation for designing interrupted time series analyses of health policy interventions. Journal of Clinical Epidemiology, 64, 1252-1261.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2014
Actual
9/12/2014
Date of last participant enrolment
Anticipated
1/12/2016
Actual
1/07/2016
Date of last data collection
Anticipated
Actual
20/12/2017
Sample size
Target
12
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 6402 0
New Zealand
State/province [1] 6402 0
Auckland

Funding & Sponsors
Funding source category [1] 290074 0
University
Name [1] 290074 0
University of Auckland Doctoral Scholarship
Postgraduate Research Spending Account
Country [1] 290074 0
New Zealand
Funding source category [2] 290717 0
University
Name [2] 290717 0
University of Auckland Senior Health Research Scholarship
Doctoral spending account
Country [2] 290717 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Psychology
Tamaki Campus
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288768 0
None
Name [1] 288768 0
Address [1] 288768 0
Country [1] 288768 0
Other collaborator category [1] 278333 0
Individual
Name [1] 278333 0
Dr. Javier Virues-Ortega
Address [1] 278333 0
School of Psychology
Tamaki Campus
University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 278333 0
New Zealand
Other collaborator category [2] 278334 0
Individual
Name [2] 278334 0
Prof. Suzanne Purdy
Address [2] 278334 0
School of Psychology
Tamaki Campus
University of Auckland
Private Bag 92019
Auckland 1142
Country [2] 278334 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291779 0
Health and Disability Ethics Committee
Ethics committee address [1] 291779 0
Ethics committee country [1] 291779 0
New Zealand
Date submitted for ethics approval [1] 291779 0
25/09/2014
Approval date [1] 291779 0
14/11/2014
Ethics approval number [1] 291779 0
14/NTA/162

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 303 303 0 0
/AnzctrAttachments/367234-Document 6 - Advertisementb.pdf

Contacts
Principal investigator
Name 51994 0
Ms Sarah Leadley
Address 51994 0
School of Psychology
Tamaki Campus
University of Auckland
Private Bag 92019
Auckland 1142
Country 51994 0
New Zealand
Phone 51994 0
+64 27 9313551
Fax 51994 0
Email 51994 0
s.leadley@auckland.ac.nz
Contact person for public queries
Name 51995 0
Sarah Leadley
Address 51995 0
School of Psychology
Tamaki Campus
University of Auckland
Private Bag 92019
Auckland 1142
Country 51995 0
New Zealand
Phone 51995 0
+64 27 9313551
Fax 51995 0
Email 51995 0
s.leadley@auckland.ac.nz
Contact person for scientific queries
Name 51996 0
Sarah Leadley
Address 51996 0
School of Psychology
Tamaki Campus
University of Auckland
Private Bag 92019
Auckland 1142
Country 51996 0
New Zealand
Phone 51996 0
+64 27 9313551
Fax 51996 0
Email 51996 0
s.leadley@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.