None listed
Conditions
Brief summary
This study will evaluate the efficacy of three feeding intervention programs for children recovering from cancer with feeding difficulties and/or restricted oral intake. Who is it for? Children can join this study if they are aged between 1 and 6 years, are stable and/or in their maintenance phase of treatment for cancer, and have a feeding difficulty and/or restricted range of oral intake (e.g. limited range of foods, prolonged mealtime duration, problematic behaviour at mealtimes, parent stress related to mealtimes). Trial details: Participants of this trial will be offered a comprehensive assessment of feeding, general development and nutrition in the first instance. Children identified as eligible, based on these assessments, will be randomly (by chance) divided into one of three groups. Group 1 will undergo an individual child-directed behaviour modification program, Group 2 will undergo small group child-directed sensory desensitisation program, and Group 3 will involve group parent education sessions on general nutrition and behaviour management for children with feeding difficulties. Treatment will be offered in weekly sessions for a 10 week block (10 sessions). Participants who are unable to commit for weekly intervention for 10 weeks will be offered the opportunity to be placed on a wait list for intensive intervention (10 sessions in 1 week). Assessments will be conducted at baseline, immediately post treatment, and 3 months post treatment to determine the impact of the programs on dietary variety, overall nutrition, maladaptive behaviours and parent stress.
Interventions
Arm One: HELPing Mealtime Behaviour
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 a verbal prompt to encourage consumption of spoonfuls of new food/s , with positive reinforcement (verbal and/or with toys etc), upon consumption of these foods. Parents initially obser
Arm One: HELPing Mealtime Behaviour 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 a verbal prompt to encourage consumption of spoonfuls of new food/s , with positive reinforcement (verbal and/or with toys etc), upon consumption of these 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). Involves the child being exposed to gradually more challenging modelling and play with food (based on a sensory heirarchy of look>touch>smell>taste). Parents initially observe the sessions from behing 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 room; 1 parent and secondary therapist outside of room). Arm Three: HELPing Mealtime Knowledge. Type of intervention: Parent education regarding nutrition and behaviour management. Delivery of Intervention: This is a parents only intervention. In groups of 6, parents are provided with a 3 hour education session regarding general nutrition and behaviour management, and will receive 2 hours of follow-up phone calls during the duration of the 10 week block. This form of intervention is not able to be run in an intensive model and will therefore only be offered in this format.
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 is stable and/or in their maintenance phase of treatment for cancer *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