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Trial registered on ANZCTR


Registration number
ACTRN12612000078853
Ethics application status
Not yet submitted
Date submitted
13/01/2012
Date registered
16/01/2012
Date last updated
16/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Level of Distress of Parents of Children Recently Diagnosed with Chronic or Life-Threatening Illnesses or Injuries or Developmental Disabilities, and Comparing the Effectiveness of Two Psychological Interventions
Scientific title
Assessing the Psychosocial Functioning of Parents of Children Recently Diagnosed with Cystic Fibrosis, Cancer, Traumatic Head Injury, or Developmental Disabilities, and Comparing the Treatment Outcomes of a Psychological Therapy that has a Meaning-Based Component with Cognitive-Behavioural Therapy
Secondary ID [1] 279728 0
Nil
Universal Trial Number (UTN)
U1111-1127-1737
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 285567 0
Post-traumatic stress disorder 285568 0
Anxiety 285569 0
Condition category
Condition code
Mental Health 285764 285764 0 0
Depression
Mental Health 285765 285765 0 0
Anxiety
Mental Health 285766 285766 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive-Behavioural Therapy: Participants meet as a group once a week for four weeks, each session lasting 1.5 hours. They will discuss their experience in managing their child's illness, the coping strategies they have used, their thoughts and feelings related to their child's illness and coping. Behavioural experiments, such as hypothesis testing and exposure will be used. Cognitive reframing of the situation will also be taught.

Meaning-focused therapy: Participants will meet as a group once a week for four weeks, each session lasting 1.5 hours. They will discuss their experience in managing their child's illness, as well as narrate life before and after their child's illness. The coping strategies they have used to manage their child's illness will also be discussed, and brought into the context of parents' lives, that is, how they have used similar strategies in the past, and to what effect it has worked. Parents will also take part in experiential exercises such as discussing their experience with family members, and restructuring their experiences in the larger context of their life story.

These sessions will be facilitated by a trained psychologist, and there will be supervision regarding the intervention sessions.

The study is is a crossover study, in which the order by which the participants receive each treatment is randomly allocated. After each treatment, there will be a washout period of one week.
Intervention code [1] 284026 0
Early detection / Screening
Intervention code [2] 284027 0
Treatment: Other
Intervention code [3] 284037 0
Behaviour
Comparator / control treatment
Treatment group: Meaning-focused therapy (4 sessions, 1.5 hours per session)

Comparator/Control Treatment:Cognitive-behavioural therapy (4 sessions, 1.5 hours per session)
Control group
Active

Outcomes
Primary outcome [1] 286286 0
Distress, anxiety, depression, anger, post-traumatic stress, and desire for help as assessed using Emotion Thermometers (cut-off > 4)
Timepoint [1] 286286 0
One day after recruitment.
Primary outcome [2] 286287 0
Greater sense of meaning after meaning-focused therapy as compared to cognitive-behavioural therapy as assessed using the Purpose in Life Test (PIL).
Timepoint [2] 286287 0
Baseline, and at 4, 8 and 20 weeks after intervention commencement.
Secondary outcome [1] 295532 0
Lower levels of depression, anxiety, and post-traumatic stress symptoms as measured by Depression, Anxiety and Stress Scale (DASS), and Impact of Events Scale (IES).
Timepoint [1] 295532 0
Baseline, and at 4, 8 and 20 weeks after intervention commencement.

Eligibility
Key inclusion criteria
English as first language
Parent(s) or major caregiver(s)
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants identified by the screening tool as not being distressed will not be included in Study 2.
Participants who did not indicate need for help in Study 1 will be excluded from Study 2.
Participants who declined to participate in either Study 1 or Study 2, or both.

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)
Use of central randomisation by phone number
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Use of simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284510 0
Self funded/Unfunded
Name [1] 284510 0
Country [1] 284510 0
Primary sponsor type
Individual
Name
Yi Ling Tay
Address
11 Monterey Court
Kardinya
WA6163
Country
Australia
Secondary sponsor category [1] 283440 0
None
Name [1] 283440 0
Address [1] 283440 0
Country [1] 283440 0
Other collaborator category [1] 260445 0
Hospital
Name [1] 260445 0
Princess Margaret Hospital for Children
Address [1] 260445 0
Princess Margaret Hospital
Roberts Road, Subiaco, Perth
Western Australia 6008
Country [1] 260445 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286491 0
Human Research Ethics Committee
Ethics committee address [1] 286491 0
Room 1.006
Chancellery Building
South Street Murdoch, WA 6150
Ethics committee country [1] 286491 0
Australia
Date submitted for ethics approval [1] 286491 0
20/01/2012
Approval date [1] 286491 0
Ethics approval number [1] 286491 0
Ethics committee name [2] 286492 0
Princess Margaret Hospital Ethics & Research Governance
Ethics committee address [2] 286492 0
Level 1
Children's Clinical Research Facility
Princess Margaret Hospital

OR

GPO Box D184
Perth WA 6840
Ethics committee country [2] 286492 0
Australia
Date submitted for ethics approval [2] 286492 0
06/02/2012
Approval date [2] 286492 0
Ethics approval number [2] 286492 0

Summary
Brief summary
Parents of children who suffer from traumatic brain injury, chronic illnesses and developmental disabilities face a myriad issues that may not be immediately apparent. Apart from the practical responsibilities associated with caring for the ill child, other areas such as making sure that the household continues running smoothly and maintaining finances compete with parents' attentions. In addition to these practical challenges, parents also face internal challenges, such as having to come to terms with the possibility of losing their child, or that their child is not going to live their lives like their peers. Hot on the heels of these realizations are the "whys" and "hows" of their children's conditions, which challenge parents' beliefs about themselves and that of the world that they live in. This especially comes to the fore when parents witness their children suffering and in pain, or compare their children with their normally developing peers. As a result of these various sources of stress, a variety of emotional disorders in parents have been found to result from the diagnosis of their children's disabilities or illnesses. Depression, anxiety, as well as post-traumatic stress symptoms (PTSS) have been found to occur most often, with higher rates commonly found in parents whose children have recently been diagnosed (Vrijmoet-Wiersma et al., 2008). Although the level of emotional distress has been found by researchers to drop as time passes, the impact of distress has been found to have long-reaching consequences, sometimes manifesting as negative family communication, increased family conflict, and negative marital relationships, which then results in a vicious cycle as it feeds back into the emotional distress faced by parents.

The diagnosis of illness or disability in a child therefore brings about a great impact on parents and the rest of the family. Although the impact of the diagnoses were described in terms of being external or internal to parents, it must be noted that these challenges interact with each other to produce either positive outcomes of growth or resilience in parents, or negative outcomes of distress. Most of the distress experienced by parents has been found by researchers to be at its most intense at the time of diagnosis, and likely to be maintained in the long run if parents' distress are not addressed. As such, the period following diagnosis appears to be crucial in assisting parents to lower their levels of distress. Hence, a screening tool that correctly identifies distressed parents without taking up too much of their time, as well as an intervention that helps them to reduce their distress, particularly existential distress, is necessary.

Study 1 is an evaluative study that aims to evaluate the accuracy of a screening approach that assesses the level of distress of parents of children recently diagnosed with traumatic brain injury, chronic and/or life-threatening illnesses such as cystic fibrosis and cancer, and developmental disabilities. It involves a comparative analysis between a set of six emotion thermometers with a more comprehensive battery of assessment tools that measure depression, anxiety, loss of meaning, and post-traumatic stress disorder (PTSD). The purpose of investigating the utility and accuracy of a screening tool is so that distressed parents can be identified and referred to the various support structures in the hospital.

Study 2, on the other hand, aims to compare the treatment outcomes between psychotherapy that is meaning-focused, with cognitive-behavioural treatment (CBT), immediately after treatment and at follow-up three months later. It involves a comparison of the specific components of both forms of therapy which can bring about a reduction of distress in the participants. The order by which the participants will receive both forms of therapy is alternated; that is, participants will be randomly allocated to a group that receives the meaning-focused therapy first, while the other group will receive CBT first, and the order will be switched at the conclusion of the prior treatment. At the conclusion of each treatment, participants will be asked to complete the assessment tools, to find out if there was a reduction in their distress.

Hypotheses:
1) There will be a clear indicator of whether the screening tool can identify parents who are distressed.
2) The screening tool will be able to identify parents who may benefit from psychological support. These parents may have been overlooked if the screening tool had not been used.
3) The meaning-focused therapy will reduce parents' distress more than cognitive-behavioural therapy.
4) The greater reduction in distress that is brought about by the meaning-focused therapy than cognitive-behavioural therapy will still be demonstrated by these parents after three months.
5) Parents will report a greater increase in sense of meaning immediately after the meaning-focused component than immediately after the cognitive-behavioural component.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33631 0
Address 33631 0
Country 33631 0
Phone 33631 0
Fax 33631 0
Email 33631 0
Contact person for public queries
Name 16878 0
Yi Ling Tay
Address 16878 0
11 Monterey Court
Kardinya
WA 6163
Country 16878 0
Australia
Phone 16878 0
+61 4 23300224
Fax 16878 0
Email 16878 0
[email protected]
Contact person for scientific queries
Name 7806 0
Yi Ling Tay
Address 7806 0
11 Monterey Court
Kardinya
WA 6163
Country 7806 0
Australia
Phone 7806 0
+61 4 23300224
Fax 7806 0
Email 7806 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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