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Trial registered on ANZCTR


Registration number
ACTRN12621001629820
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
29/11/2021
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A psycho-educational Intervention program for children of patients with hereditary dementia
Scientific title
Evaluating the efficacy of an intervention program in psycho-educational and coping strategies for depression and stress in children of patients with Early Onset Alzheimer Disease
Secondary ID [1] 303946 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early onset Alzheimer disease 321542 0
Condition category
Condition code
Neurological 319290 319290 0 0
Dementias
Neurological 319291 319291 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
According to the interest in the population studied we decided to only perform one intervention session that will consist in 1 face-to-face session of 2 hours addressed to clear the doubts of the genetic counseling performed and to increase emotional intelligence and coping strategies.

The genetic counseling will be administered by a psychologist trained in the genetic disease.
The methods/strategies would be a general psycho-educational program where the description of emotional intelligence will be given, specifying what are the positive and negative emotions, how to identify them, how to identify the causes of these emotions and how can we modify the negative emotions by identifying the cause and changing the psycho-emotional pattern that resulted in that emotion.

For coping strategies to better manage the stress, will be addressed to identify the problems os stressors that can be modified, and those that can not be modified. For those that can be modified, the participants will be encouraged to adopt and active copping strategy, which is addressed to plan the steps to solve the problem. For those that can not be modified the adaptive coping strategy of acceptance will be encouraged.
Intervention code [1] 320255 0
Treatment: Other
Comparator / control treatment
A control group conformed of children of patients with Early Onset Alzheimer Disease, with no intervention is planned to be measured in parallel of the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 327172 0
Depression measured with the CESD-IS instrument
Timepoint [1] 327172 0
1 week after the last session
Primary outcome [2] 327173 0
Stress measured with the scale of perceived stress of Cohen
Timepoint [2] 327173 0
1 week after the session
Secondary outcome [1] 394051 0
The intention to take a pre-diagnostic test, which will be assessed by a simple question with 4 options: yes, no, may be later and I do not know
Timepoint [1] 394051 0
1 week after the last session

Eligibility
Key inclusion criteria
Children of patients diagnosed with Early Onset Alzheimer disease
Be aware of the diagnosis of the affected parent
Older than 18 years old
Have no symptoms of the disease
That accept to participate in the study
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those participants that do not complete the intervention sessions
Those participants that do not complete the basal and post-test measurements
Those participants that initiate with symptoms of the disease
Those participants that want to withdraw from the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation procedure will be performed with sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization using a random number generator
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
Mann Whitney U test comparing the differences in the following 2 outcome variables, comparing the differences post-pre in each one:
1.- Depression
2.- Perceived Stress
A chi-squared test comparing the changes in the intention to take the genetic (pre-diagnostic) test
3.- Intention to take the genetic (pre-diagnostic) test

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/01/2022
Actual
Date of last participant enrolment
Anticipated
4/02/2022
Actual
Date of last data collection
Anticipated
18/03/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 23596 0
Mexico
State/province [1] 23596 0
Jalisco

Funding & Sponsors
Funding source category [1] 308330 0
Self funded/Unfunded
Name [1] 308330 0
Country [1] 308330 0
Primary sponsor type
Individual
Name
Aniel Jessica Leticia Brambila Tapia
Address
Universidad de Guadalajara, Centro Universitario de Ciencias de la Salud (CUCS), Address: Sierra Mojada #950, Colonia Independencia, Guadalajara, Jalisco, México
Country
Mexico
Secondary sponsor category [1] 309142 0
Individual
Name [1] 309142 0
Luis Eduardo Figuera Villanueva
Address [1] 309142 0
Centro de Investigación Biomédica de Occidente (CIBO), Instituto Mexicano del Seguro Social (IMSS), Address: Sierra Mojada #800, Colonia Independencia, Guadalajara, Jalisco, México
Country [1] 309142 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308306 0
Comité de Investigación del Centro Universitario de Ciencias de la Salud (CUCS)
Ethics committee address [1] 308306 0
Sierra Mojada #950, colonia Independencia, Guadalajara, Jalisco, México
Ethics committee country [1] 308306 0
Mexico
Date submitted for ethics approval [1] 308306 0
03/08/2020
Approval date [1] 308306 0
02/10/2020
Ethics approval number [1] 308306 0
20-103

Summary
Brief summary
The Early Onset Alzheimer disease (EOAD) is an autosomal dominant disease that is transmitted to the offspring with a chance of 50% in each pregnancy. The age of onset is around 35 years old and the duration of the disease before death is around 10 years.
In the town of the Jalisco state: "Los Altos de Jalisco", a group of patients comprising around 40 families are identified with a unique mutation causing EOAD.
The disease can be detected before it initiate with symptoms in the offspring of affected patients, however this detection is not performed routinely to date, therefore this study is addressed to identify the intention to perform the genetic pre-symptomatic test by clearing the doubts referring the diagnosis and increasing emotional and coping strategies that permit the offspring to diminish depression and stress levels and to take an informed decision about to take or not the genetic test.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110242 0
Dr Aniel Jessica Leticia Brambila Tapia
Address 110242 0
Universidad de Guadalajara, Centro Universitario de Ciencias de la Salud (CUCS), Address: Sierra Mojada #950, Colonia Independencia, Guadalajara, Jalisco, México
Country 110242 0
Mexico
Phone 110242 0
+523310941782
Fax 110242 0
Email 110242 0
[email protected]
Contact person for public queries
Name 110243 0
Dr Aniel Jessica Leticia Brambila Tapia
Address 110243 0
Universidad de Guadalajara, Centro Universitario de Ciencias de la Salud (CUCS), Address: Sierra Mojada #950, Colonia Independencia, Guadalajara, Jalisco, México
Country 110243 0
Mexico
Phone 110243 0
+523310941782
Fax 110243 0
Email 110243 0
[email protected]
Contact person for scientific queries
Name 110244 0
Dr Aniel Jessica Leticia Brambila Tapia
Address 110244 0
Universidad de Guadalajara, Centro Universitario de Ciencias de la Salud (CUCS), Address: Sierra Mojada #950, Colonia Independencia, Guadalajara, Jalisco, México
Country 110244 0
Mexico
Phone 110244 0
+523310941782
Fax 110244 0
Email 110244 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
The information about the genetic diagnosis/conditions of patients and familiars is confidential


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.