Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000879561
Ethics application status
Approved
Date submitted
2/07/2024
Date registered
18/07/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
18/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility pilot of the Tuning in to Toddlers program for parents of young children diagnosed with autism
Scientific title
Evaluating the acceptability and feasibility of the Tuning in to Toddlers parent emotion coaching program for supporting emotional development in young children diagnosed with autism
Secondary ID [1] 312442 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 334268 0
Condition category
Condition code
Mental Health 330930 330930 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, 'Tuning in to Toddlers’, studied in this trial is a developmentally adapted version of the 'Tuning in to Kids’ program, an emotion-focused parenting program for children with emotional and behavioural difficulties. The program is based on emotional socialisation theory, integrating attachment, mindfulness, and neurobiological theories and concepts. The Tuning in to Toddlers program has previously been developed and trialled for non-autistic toddlers (ACTRN12615000962538).

The intervention is parent-mediated; that is, intervention where parents are the primary agent of change for children' development. Children are not participants in this intervention; rather, parents/caregivers are the participants, with therapists providing strategies and tools for parents to implement in their everyday environments.

The intervention is manualised, with all sessions including activities to support parental understanding and regulation of their own and their child's emotions. Within the program are five steps of emotion coaching, which provides parents with a model for responding to their child's emotions and supports parental understanding of how to: (a) be aware of their child's low-intensity emotions; (b) view their child's emotions as a time for intimacy and teaching; (c) communicate understanding and acceptance towards their child's emotions; (d) name the feeling; and (e) provide comfort, assist with choices, set limits, provide distraction, or problem solve. The program is psychoeducational, delivered through watching videos, discussion about parental beliefs and experiences of emotions, role-plays, and home activities - all of which facilitate parents' ability to engage in emotion coaching. Home activities are optional and may include using worksheets to help facilitate understanding of the program content.

The intervention will be delivered as eight weekly, one-hour sessions, delivered one-on-one to parents, by community-based clinical professionals with sufficient knowledge and experience working with autistic children and families, delivered face-to-face (in a community-based clinic located in Perth) or online via video conferencing software. Two one-hour sessions, delivered at one and two-months post-program, will also be offered as optional 'booster' sessions.

Intervention fidelity will be assessed through a checklist completed by the clinician at the end of each session. Adherence to the program will be assessed through participant completion of each session and attrition.

Feedback from participants on the program acceptability will be assessed through interviews at the end of the program. Interviews will be semi-structured, using a study-specific interview guide. Interviews will be conducted by a member of the research team not involved in providing the program, lasting between 30 minutes to an hour, and will be audio recorded for transcription purposes.
Intervention code [1] 328948 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338695 0
Feasibility
Timepoint [1] 338695 0
Recruitment rates, session attendance, and attrition will be assessed upon conclusion of the study.
Primary outcome [2] 338747 0
Acceptability
Timepoint [2] 338747 0
Individual session ratings will be collected at the end of each weekly session. Interviews will be completed at follow-up (four months post-baseline).
Secondary outcome [1] 437056 0
Parent Emotional Style Questionnaire
Timepoint [1] 437056 0
Measured at baseline, two-months post-baseline, and four-months post-baseline
Secondary outcome [2] 437057 0
Emotion Socialisation Questionnaire
Timepoint [2] 437057 0
Measured at baseline, two-months post-baseline, and four-months post-baseline
Secondary outcome [3] 437272 0
Coping with Toddlers Negative Emotions Scale
Timepoint [3] 437272 0
Measured at baseline, two-months post-baseline, and four-months post-baseline
Secondary outcome [4] 437273 0
Difficulties In Emotion Regulation Scale
Timepoint [4] 437273 0
Measured at baseline, two-months post-baseline, and four-months post-baseline
Secondary outcome [5] 437274 0
Parenting Sense of Confidence
Timepoint [5] 437274 0
Measured at baseline, two-months post-baseline, and four-months post-baseline
Secondary outcome [6] 437275 0
Autism Parent Stress Index
Timepoint [6] 437275 0
Measured at baseline, two-months post-baseline, and four-months post-baseline

Eligibility
Key inclusion criteria
Parent^ of a child:
(1) aged between 18 - 48 months of age;
(2) diagnosed with autism (autism, or autism spectrum disorder) or awaiting confirmation of an autism diagnosis (following diagnostic assessment);
(3) experiencing emotion regulation difficulties (parent-reported).

Parent:
(1) can attend most planned intervention sessions;
(2) can complete the program, questionnaires, and interview in English.

^'Parent' is an inclusive term, referring to anyone who takes a primary caregiving role for the child related to this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Unable to attend most planned intervention sessions;
(2) Any active court proceedings or special care arrangements; and
(3) Parental mental or physical health condition that causes significant distress and or impact on parenting and family life at the time of participation.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/08/2024
Actual
30/08/2024
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316859 0
Other
Name [1] 316859 0
CliniKids, The Kids Research Institute Australia - in-kind staff time and resources
Country [1] 316859 0
Australia
Funding source category [2] 316901 0
University
Name [2] 316901 0
University of Melbourne - in-kind staff time, provision of training, and resources
Country [2] 316901 0
Australia
Primary sponsor type
Other
Name
The Kids Research Institute Australia
Address
Country
Australia
Secondary sponsor category [1] 319095 0
None
Name [1] 319095 0
Address [1] 319095 0
Country [1] 319095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315618 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 315618 0
Ethics committee country [1] 315618 0
Australia
Date submitted for ethics approval [1] 315618 0
30/04/2024
Approval date [1] 315618 0
26/06/2024
Ethics approval number [1] 315618 0
2024/ET000183

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

Contacts
Principal investigator
Name 135274 0
Dr Gail Alvares
Address 135274 0
CliniKids, The Kids Research Institute Australia
100 Roberts Road Subiaco WA 6008
Country 135274 0
Australia
Phone 135274 0
+61 8 6319 1698
Fax 135274 0
Email 135274 0
gail.alvares@thekids.org.au
Contact person for public queries
Name 135275 0
Gail Alvares
Address 135275 0
CliniKids, The Kids Research Institute Australia
100 Roberts Road Subiaco WA 6008
Country 135275 0
Australia
Phone 135275 0
+61 8 6319 1698
Fax 135275 0
Email 135275 0
gail.alvares@thekids.org.au
Contact person for scientific queries
Name 135276 0
Gail Alvares
Address 135276 0
CliniKids, The Kids Research Institute Australia
100 Roberts Road Subiaco WA 6008
Country 135276 0
Australia
Phone 135276 0
+61 8 6319 1698
Fax 135276 0
Email 135276 0
gail.alvares@thekids.org.au

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?

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.