Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000436673
Ethics application status
Approved
Date submitted
28/03/2014
Date registered
29/04/2014
Date last updated
29/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hassle Free Mealtimes Triple P: Evaluation of a Parenting Group for Problem Eating in Childhood Using Observational Data.
Scientific title
The impact of Brief Hassle Free Mealtimes Triple P on child behaviour and parenting for toddler and preschool children with mealtime difficulties, using observed child and parent behaviour.
Secondary ID [1] 284357 0
Nil
Universal Trial Number (UTN)
U1111-1155-0782
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem eating or mealtime behaviour 291516 0
Condition category
Condition code
Diet and Nutrition 291885 291885 0 0
Other diet and nutrition disorders
Mental Health 291886 291886 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Hassle-Free Mealtimes Triple P (Morawska & Sanders, in press) is a Level 2 Triple P intervention based on the principles of behavioural family intervention and social learning. Parents attending the Hassle-Free Mealtimes program will receive one 2-hour group session on the causes of childhood feeding difficulties, establishing eating routines and ground rules, and various behavioural strategies including praise, positive attention, behaviour charts, modelling, planned ignoring, instructions and consequences. The program will be delivered by trained practitioners to groups of 10-12 parents. Teaching methods will include didactic instruction, active skills training and homework tasks so that parents may achieve mastery of skills.
Intervention code [1] 289086 0
Behaviour
Comparator / control treatment
A waitlist control design will be applied whereby half of the parents will be randomly allocated to wait 4 weeks and complete measures again before receiving the program.
Control group
Active

Outcomes
Primary outcome [1] 291806 0
Parent-reported child mealtime behaviour on the Parent and Toddler Feeding Assessment (PATFA; Adamson, Morawska, & Sanders, 2008). The PATFA is a 90-item measure of child feeding behaviour and corresponding parental strategies, beliefs, emotions and knowledge related to feeding. Parents rated 21 child feeding items as to the frequency of each (on a 5-point Likert scale) and whether each is a problem (yes/no).
Timepoint [1] 291806 0
Measures will be administered upon entry to the study (Time 1) and then four weeks later (Time 2). For families in the start now group, this will be 4 weeks after their group session; families assigned to the start later group will receive no intervention for the same number of weeks (5 weeks) and then complete the measures before participating in the intervention. The families in the start now group will be assessed once more six months after the completion of the intervention for follow-up (Time 3).
Primary outcome [2] 291807 0
Mealtime-specific parenting style, parenting confidence and beliefs, emotions and knowledge related to feeding, rated on the PATFA (Adamson et al., 2008). Parents rate how frequently they use 30 mealtime strategies on a 5-point scale (Parent Strategies), their agreement with 39 statements about feeding on a 5-point scale (Parent Cognitions), and their level of confidence in managing each of the 21 child feeding behaviours noted above on a scale of 1-10 (Parent Confidence).
Timepoint [2] 291807 0
Measures will be administered upon entry to the study (Time 1) and then four weeks later (Time 2). For families in the start now group, this will be 4 weeks after their group session; families assigned to the start later group will receive no intervention for the same number of weeks (5 weeks) and then complete the measures before participating in the intervention. The families in the start now group will be assessed once more six months after the completion of the intervention for follow-up (Time 3).
Primary outcome [3] 291808 0
Observed child and parent behaviour during an evening meal, coded with the Mealtime Observation Schedule (Sanders, Le Grice, & Turner, 1993). The MOS employs an interval time sampling procedure to record the presence of 16 child and 14 parent behaviour categories over consecutive 10-second intervals. Scores are combined into four summary scores according to the percentage of intervals in which the child demonstrated appropriate behaviour (Child positive); the child demonstrated inappropriate behaviour (Child negative); the parent displayed only positive behaviour toward the child (Parent positive); and the parent displayed any aversive behaviour toward the child (Parent negative).
Timepoint [3] 291808 0
Observations will be conducted upon entry to the study (Time 1) and then four weeks later (Time 2). For families in the start now group, this will be 4 weeks after their group session; families assigned to the start later group will receive no intervention for the same number of weeks (5 weeks) and then complete the measures before participating in the intervention. The families in the start now group will be assessed once more six months after the completion of the intervention for follow-up (Time 3).
Secondary outcome [1] 307585 0
Child behavioural and emotional adjustment as measured by the Child Adjustment and Parent Efficacy Scale (CAPES; Morawska & Sanders, 2010). This measure consists of 30 items rated on a 4-point scale (0 = not true of my child at all to 3 = true of my child very much, or most of the time). Twenty six items assess behaviour concerns (e.g., My child rudely answers back to me) and behavioural competencies (Behaviour Scale; e.g., My child accepts rules and limits), and four items assess emotional adjustment (Emotional Adjustment Scale; e.g., My child worries).
Timepoint [1] 307585 0
Measures will be administered upon entry to the study (Time 1) and then four weeks later (Time 2). For families in the start now group, this will be 4 weeks after their group session; families assigned to the start later group will receive no intervention for the same number of weeks (5 weeks) and then complete the measures before participating in the intervention. The families in the start now group will be assessed once more six months after the completion of the intervention for follow-up (Time 3).
Secondary outcome [2] 307586 0
Parental efficacy as measured by the CAPES (Morawska & Sanders, 2010). The Efficacy Scale measures parents' level of confidence in managing child emotional and behavioural problems and consists of 20 items rated on a 10-point scale (from 1 = certain I can't do it to 10 = certain I can do it).
Timepoint [2] 307586 0
Measures will be administered upon entry to the study (Time 1) and then four weeks later (Time 2). For families in the start now group, this will be 4 weeks after their group session; families assigned to the start later group will receive no intervention for the same number of weeks (5 weeks) and then complete the measures before participating in the intervention. The families in the start now group will be assessed once more six months after the completion of the intervention for follow-up (Time 3).
Secondary outcome [3] 307587 0
Parenting practices, parent adjustment, family relationships, and couple relationships, as measured by the Parenting and Family Adjustment Scale (PAFAS; Sanders & Morawska, 2010). Parents rate each of the 40-items on a 4-point scale (0 = not true of me at all, to 3 = true of me very much, or most of the time).
Timepoint [3] 307587 0
Measures will be administered upon entry to the study (Time 1) and then four weeks later (Time 2). For families in the start now group, this will be 4 weeks after their group session; families assigned to the start later group will receive no intervention for the same number of weeks (5 weeks) and then complete the measures before participating in the intervention. The families in the start now group will be assessed once more six months after the completion of the intervention for follow-up (Time 3).
Secondary outcome [4] 307588 0
Child anxiety as measured by the Childhood Concerns Survey (CCS; Edwards, Rapee, Kennedy, & Spence, 2010), a 28-item parent-report measure of anxiety in young children.
Timepoint [4] 307588 0
Measures will be administered upon entry to the study (Time 1) and then four weeks later (Time 2). For families in the start now group, this will be 4 weeks after their group session; families assigned to the start later group will receive no intervention for the same number of weeks (5 weeks) and then complete the measures before participating in the intervention. The families in the start now group will be assessed once more six months after the completion of the intervention for follow-up (Time 3).
Secondary outcome [5] 307589 0
Parent and child food neophobia (a reluctance to try new foods), as measured by the Food Neophobia Scale (FNS; Pliner & Hobden, 1993) and Children's Food Neophobia Scale (CFNS; Cooke, Carnell, & Wardle, 2006) which contain 10 and 6 items respectively and are rated by the parent.
Timepoint [5] 307589 0
Measures will be administered upon entry to the study (Time 1) and then four weeks later (Time 2). For families in the start now group, this will be 4 weeks after their group session; families assigned to the start later group will receive no intervention for the same number of weeks (5 weeks) and then complete the measures before participating in the intervention. The families in the start now group will be assessed once more six months after the completion of the intervention for follow-up (Time 3).

Eligibility
Key inclusion criteria
Parent of a child aged 2-5 years of age who is concerned about their child's feeding and/or mealtimes.
Minimum age
2 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Child with a disability and/or chronic illness, including language and speech impairment; b) Parents currently seeing a professional for the child’s behaviour difficulties; c) Parents currently receiving psychological/psychiatric help or counselling (personal/marital); d) Parents intellectually disabled and/or hearing impaired.

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)
Following screening and upon completion of Time 1 measures, participants will be allocated in turn by opening a sequentially numbered sealed envelope. The sequence in the envelopes has been created by an independent third party, so that the allocation sequence is concealed from the researcher assessing participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be determined via a computer-generated list of random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/04/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7946 0
4655
Recruitment postcode(s) [2] 7947 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 288995 0
Self funded/Unfunded
Name [1] 288995 0
Dr. Alina Morawska
Country [1] 288995 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Dr. Alina Morawska
Parenting and Family Support Centre
School of Psychology
The University of Queensland
ST LUCIA Qld 4072
Country
Australia
Secondary sponsor category [1] 287675 0
None
Name [1] 287675 0
Address [1] 287675 0
Country [1] 287675 0
Other collaborator category [1] 277903 0
University
Name [1] 277903 0
Dr. Michelle Adamson
University of Southern Queensland
Address [1] 277903 0
School of Psychology, Counselling, and Community
University of Southern Queensland
P O Box 910
HERVEY BAY Qld 4655
Country [1] 277903 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290803 0
Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 290803 0
Ethics committee country [1] 290803 0
Australia
Date submitted for ethics approval [1] 290803 0
Approval date [1] 290803 0
12/03/2014
Ethics approval number [1] 290803 0
2014000095

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47342 0
Dr Alina Morawska
Address 47342 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia Qld 4072
Country 47342 0
Australia
Phone 47342 0
+61733657304
Fax 47342 0
Email 47342 0
[email protected]
Contact person for public queries
Name 47343 0
Alina Morawska
Address 47343 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia Qld 4072
Country 47343 0
Australia
Phone 47343 0
+61733657304
Fax 47343 0
Email 47343 0
[email protected]
Contact person for scientific queries
Name 47344 0
Alina Morawska
Address 47344 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia Qld 4072
Country 47344 0
Australia
Phone 47344 0
+61733657304
Fax 47344 0
Email 47344 0
[email protected]

No information has been provided regarding IPD availability


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
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