Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000474550
Ethics application status
Approved
Date submitted
21/03/2024
Date registered
17/04/2024
Date last updated
17/04/2024
Date data sharing statement initially provided
17/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Experiences of parents of adolescents with Type 1 Diabetes (T1D) following an Internet-based Acceptance and Commitment Therapy (ACT) intervention to address their psychosocial needs: A Pilot Study
Scientific title
Feasibility and Acceptability of an internet-based Acceptance and Commitment Therapy (ACT) intervention to address the psychosocial needs of parents of adolescents with Type 1 Diabetes (T1D): A Pilot Study
Secondary ID [1] 311551 0
Nil known
Universal Trial Number (UTN)
U1111-1304-3454
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parental Stress 332912 0
Condition category
Condition code
Mental Health 329626 329626 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An online telehealth delivered acceptance and commitment therapy (ACT) intervention has been developed for parents of adolescents with Type 1 Diabetes (T1D). The online intervention has been developed by exploring previous acceptance and commitment therapy (ACT) Protocols, and has been adapted to meet the needs for this client population. Expert reviewers provided feedback on the suitability and acceptability of the intervention.

Parents with adolescents aged between 12 and 17 years, who have had a diagnosis of Type 1 Diabetes (T1D) for at least 1 year will be recruited. The project involves parents participating in Acceptance and Commitment Therapy (ACT) online workshop sessions through an online platform at Curtin University for 1½ hours per week over a period of 6 weeks. The intervention will be an interactive group intervention which will consist of 10-14 participants. The content of the sessions will focus on the six core processes of Acceptance and Commitment Therapy (ACT): cognitive defusion, acceptance, self as context (self-compassion), contact with the present moment, values, and committed action. The workshop sessions will provide parents with skills and strategies to help manage the stress they experience in parenting their adolescent with Type 1 Diabetes (T1D). These skills and strategies include experiencial practices that encourage mindfulness and acceptance. Parents will be provided with and encouraged to complete a 10 minute mindfulness practice at least three times a week as homework. At the beginning of each session fom the beginning of week two, discussion will take place as to parents' experiences of practicing the mindfulness practice. Parents will be asked to attend all workshop sessions and complete some assessments before, after and three months following the intervention, which will take approximately 30 minutes at each time point.

The main researcher (Clinical Psychologist) will deliver the intervention with the support of a fellow researcher with experience in working with parents of children/adolescents with Type 1 Diabetes.
Intervention code [1] 328004 0
Treatment: Other
Intervention code [2] 328333 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337494 0
Feasibility of the ACT intervention assessed as a composite outcome
Timepoint [1] 337494 0
Feasibility will be measured upon completion of the study (post-intervention)
Primary outcome [2] 337495 0
Acceptability of the ACT intervention as a composite outcome
Timepoint [2] 337495 0
Rates of workshop attendance and homework completion will be assessed post-intervention by examining the study checklists completed at the end of each intervention session.

The Program Evaluation Questionnaire will be completed post the intervention.

The semi-structured interviews will be undertaken three months post-completion of the intervention.
Secondary outcome [1] 431818 0
Levels of stress, depression and anxiety in parents as a composite outcome
Timepoint [1] 431818 0
Pre-intervention, within 1 week Post-completion of intervention, and 3 months following completion of intervention
Secondary outcome [2] 431819 0
Measure of self-compassion in parents
Timepoint [2] 431819 0
Pre-intervention, within 1 week Post-completion of intervention, and 3 months following completion of intervention
Secondary outcome [3] 431820 0
Measure of parents level of intolerance to uncertainty
Timepoint [3] 431820 0
Pre-intervention, within 1 week Post-completion of intervention, and 3 months following completion of intervention
Secondary outcome [4] 432093 0
Change in mindfulness in parents
Timepoint [4] 432093 0
Pre-intervention, within 1 week Post-completion of intervention, and 3 months following completion of intervention
Secondary outcome [5] 432094 0
Change in psychological flexibility in parents
Timepoint [5] 432094 0
Pre-intervention, within 1 week Post-completion of intervention, and 3 months following completion of intervention
Secondary outcome [6] 432095 0
Change in parental stress
Timepoint [6] 432095 0
Pre-intervention, within 1 week Post-completion of intervention, and 3 months following completion of intervention

Eligibility
Key inclusion criteria
To be included in the study potential participants must meet the following inclusion criteria: 1) must be parenting an adolescent with a diagnosis of Type 1 Diabetes (T1D) of more than one year, between the ages of 12 - 17 years, 2) parents must agree to assessment requirements, 3) parents must have reliable internet access, 4) parents must have sufficient English (e.g. Year 6 English level) to participate in the intervention and complete assessments. Parents will also need to provide informed consent to participate in this study.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents who have an adolescent who has recently been diagnosed (e.g. within 12 months) will be excluded from this study. Parents who do not speak sufficient English will also be excluded from the study.

Study design
Purpose of the study
Educational / counselling / training
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
Efficacy
Statistical methods / analysis
According to the National Centre for Complementary and Integrative Health, a sample size is determined by “practical considerations including participant flow, budgetary constraints, and the number of participants needed to reasonably evaluate feasibility goals.” As a sample of 60 participants can establish feasibility (Teresi et al., 2022; Whitehead et al., 2016), this exploratory study will recruit 60 participants. 30 parents will be from urban contexts; 30 parents will be from rural/remote contexts.

These participants will be recruited through relevant sources (Type 1 Diabetes organisations) for this study.

Demographic information will be collected and summarised with descriptive statistics.

Analysis of quantitative data will be completed with SPSS27 software. For the primary outcomes (met/unmet) Chi-squared tests will e performed by urban/rural remote status.
Means and standard deviations of the secondary outcome measures will be generated for baseline, post-intervention, and three-month follow-up. Findings from this exploratory study will inform the sample size calculation of future studies.

The primary feasibility outcomes will be recruitment and retention. Recruitment rate will be met if at least 70% of the planned participants participate in the study. Retention rate will be assessed by calculating the proportion of participants who complete the study out of the number enrolled, with a 95% confidence interval. Acceptability of the intervention will be met if 80% of participants complete the intervention, together with completion of the homework tasks.

References:

Teresi, J. A., Yu, X., Stewart, A. L., & Hays, R. D. (2022). Guidelines for designing and evaluating feasibility pilot studies. Medical care, 60(1), 95-103.

Whitehead, A. L., Julious, S. A., Cooper, C. L., & Campbell, M. J. (2016). Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical methods in medical research, 25(3), 1057-1073.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315846 0
University
Name [1] 315846 0
C/- Curtin University
Country [1] 315846 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 317979 0
None
Name [1] 317979 0
Address [1] 317979 0
Country [1] 317979 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314702 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 314702 0
Ethics committee country [1] 314702 0
Australia
Date submitted for ethics approval [1] 314702 0
21/09/2021
Approval date [1] 314702 0
01/11/2021
Ethics approval number [1] 314702 0
HRE2021-0696

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

Contacts
Principal investigator
Name 132446 0
Mrs Maria Davey
Address 132446 0
C/- Curtin University, GPO Box U1987, Perth Western Australia, 6845
Country 132446 0
Australia
Phone 132446 0
+61 0420478177
Fax 132446 0
Email 132446 0
[email protected]
Contact person for public queries
Name 132447 0
Maria Davey
Address 132447 0
C/- Curtin University, GPO Box U1987, Perth Western Australia, 6845
Country 132447 0
Australia
Phone 132447 0
+61 0420478177
Fax 132447 0
Email 132447 0
[email protected]
Contact person for scientific queries
Name 132448 0
Maria Davey
Address 132448 0
C/- Curtin University, GPO Box U1987, Perth Western Australia, 6845
Country 132448 0
Australia
Phone 132448 0
+61 0420478177
Fax 132448 0
Email 132448 0
[email protected]

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.