None listed
Conditions
Brief summary
This study will be a randomised controlled trial to evaluate the clinical benefits and cost-effectiveness of two child-directed feeding intervention programs for children from complex medical backgrounds (cardiac, respiratory, gastrointestinal) with feeding difficulties and restricted range of oral intake (<30 foods across the food groups). Baseline assessments will include parent-completed questionnaires on-site (Herston) and feeding and growth evaluations. There are two arms of intervention. Arm One is an individual behaviour modification program. Arm Two involves small group sensory desensitization therapy. Intervention will be provided over three phases. In Phase One, interventions will be provided weekly, over a 10-week period. Phase Two will involve offering a further block of therapy, (Arm One or Arm Two), where appropriate, over a 10 week period. Phase Three will involve providing either arm one or arm two on an intensive basis.
Interventions
Type of intervention: One-on-one behaviour modification therapy.
Delivery of intervention: To be run in individual sessions for 1 hour per week over 10 weeks (weekly schedule) or run twice daily over 1 week (intensive schedule).
Description of intervention: Involves providing verbal prompts to encourage consumption of food/s with positive reinforcement (verbal prompts with/without toy etc), upon consumption of target foods. Parents initially observe from behind a one-way mirror and assist in c
Type of intervention: One-on-one behaviour modification therapy. Delivery of intervention: To be run in individual sessions for 1 hour per week over 10 weeks (weekly schedule) or run twice daily over 1 week (intensive schedule). Description of intervention: Involves providing verbal prompts to encourage consumption of food/s with positive reinforcement (verbal prompts with/without toy etc), upon consumption of target foods. Parents initially observe from behind a one-way mirror and assist in collecting information about the behaviours they are observing in their child. As sessions continue, parents are transitioned into the room and are trained to offer new foods and provide positive reinforcement by the end of the therapy block. Arm Two: HELPing Mealtime Experience Type of Intervention: Small group sensory desensitisation therapy. Delivery of intervention: Run in small group sessions for 1 hour per week over 10 weeks (weekly schedule) or twice daily for 1 week (intensive schedule). Description of intervention: Involves the child being exposed to a gradually more challenging modelling and play with food (based on a sensory heirarchy of look>touch>smell>taste). Parents initially observe the sessions from behind a one-way mirror with a second therapist and assist in observing transitions and reactions in their children. As the block continues, parents are rotated in and out of the room to assist in modeling play using the sensory hierarchy (i.e. 1 parent and primary therapist in the room; 1 parent and secondary therapist outside of the room).
Sponsors
Children's Nutrition Research Centre, University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
Children will be eligible for assessment to further determine suitability for participation if: *Child is aged between 1 and 6 years *Child was born at <37 weeks GA. *Child must present with at least one of the following features: 1. Limited range of textures; 2. Limited range of foods; 3. Prolonged mealtime duration; 4. Battles or problematic behaviour at mealtimes; 5. Family stress related to mealtimes
Exclusion criteria
*Acutely unwell children *Children with documented aspiration on solid food textures (children with liquid aspiration are still eligible) *Children who are nutritionally unstable (severe malnutrition, gut malabsorption disorders, allergy/intolerance to > 2 food types) *Children whose parent or carer has a documented mental health condition *Children whose family’s primary language is that other than English, or children from an Aboriginal or Torres Strait Islander background
Outcome results
None listed