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Trial registered on ANZCTR


Registration number
ACTRN12612000390886
Ethics application status
Approved
Date submitted
22/02/2012
Date registered
5/04/2012
Date last updated
30/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
First Aid Training for Parents of Teenagers - a Randomized Controlled Trial
Scientific title
The effects of physical or mental health first aid training of parents on their teenager's perception of support, help-seeking, mental health or an injury needing assistance, over the adolescent period.
Secondary ID [1] 263066 0
Nil
Universal Trial Number (UTN)
U1111-1124-6490
Trial acronym
First Aid TPOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parents' mental health first aid knowledge. 270808 0
Parents' confidence in supporting an adolescent child with a mental health problem. 270814 0
Parents' self-reported supportive behaviours if their adolescent child develops a mental health problem. 270815 0
Adolescents' intentions to seek help from family and professionals for mental health problems. 270816 0
Adolescents' help-seeking from the parent for mental health problems. 270817 0
Adolescents' help-seeking from professionals for mental health problems. 270818 0
Adolescents' perceptions of support from the parent if the adolescent develops a mental health problem. 270819 0
Adolescents' perceptions of general social support from the parent. 270820 0
Mental health of the child. 270821 0
Parents' supportive behaviours towards people (other than their children) with a mental health problem. 270823 0
Help-seeking of the parent if the parent has a mental health problem. 270824 0
Mental health of the parent. 270825 0
Confidence in assisting an adolescent child with an injury needing assistance. 270826 0
First aid actions towards an adolescent child with an injury needing assistance. 270827 0
First aid actions towards people (other than the child) with an injury needing assistance. 270828 0
Condition category
Condition code
Public Health 270999 270999 0 0
Health promotion/education
Mental Health 271007 271007 0 0
Depression
Injuries and Accidents 271011 271011 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
14-hour Youth Mental Health First Aid (MHFA) course which teaches adults who care for or work with teenagers, the skills needed to recognize the early signs of mental illness, identify potential mental health-related crises, and assist teenagers to get the help they need as early as possible. The course will be delivered to a group of up to 20 parents who have a teenager aged between 12-15 years, by an accredited Youth MHFA Instructor in blocks of: 7 hours over 2 consecutive days, or over 2 consecutive Saturdays (both from 9am - 5pm) or over 4 consecutive weekly evening sessions of 3.5 hours each (from 6.30pm - 10pm).
Intervention code [1] 269422 0
Prevention
Intervention code [2] 269430 0
Early detection / Screening
Comparator / control treatment
15-hour Australian Red Cross Apply First Aid course which teaches the knowledge and skills to sustain life, reduce pain and minimize the consequences of injury and illness until professional help arrives. This is the standard course for the public and is not specifically aimed at parents of teenagers. The course will be delivered to a group of up to 20 parents who have a teenager aged between 12-15 years, by an accredited First Aid Instructor in blocks of: 7 hours over 2 consecutive days, or over 2 consecutive Saturdays (both from 9am - 5pm) or over 4 consecutive weekly evening sessions of 3.5 hours (from 6.30pm - 10pm).
Control group
Active

Outcomes
Primary outcome [1] 279662 0
The SDQ (adapted for phone interview based on Goodman, 2001) is a screening measure of behavioural and emotional problems in children and adolescents and will be used to measure the mental health of the teenager. A total difficulties score of equal to or greater than 20 for teenage self-report and equal to or greater than 17 for parent report equate to an abnormal range which can be used to identify likely cases of mental health disorders.
Timepoint [1] 279662 0
at baseline, one-year post and annually up to 8 years post intervention (till Dec 2020).
Primary outcome [2] 279663 0
Teenager's perceptions of parental support if the teenager developed a mental health problem, "How well did your mother/father support you when you had your mental health problem?" (questions developed for this study).
Timepoint [2] 279663 0
at baseline, one-year post and annually up to 8 years post intervention.
Primary outcome [3] 279679 0
Parent's self-reported supportive behaviours if their teenager developed a mental health problem. "Over the last 12 months has 'your child's name' had any sort of mental health problem?" If yes, "What do you think the problem was?" "Over the last 12 months, have you done anything to help him/her with this mental health problem?" "What did you do?" (adapted from Jorm, 2009).
Timepoint [3] 279679 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [1] 294159 0
Stigmatizing attitudes of parents and teenagers towards a person with psychosis. Social Distance Scale (Link et al., 1999). Scores range from 1 (low social distance) to 4 (high social distance).
Timepoint [1] 294159 0
at baseline, one-year post and annually for up to 8 years post intervention.
Secondary outcome [2] 294173 0
Parent's self-reported supportive behaviours over last 12 months towards people (other than their child) with a mental health problem, "What did you do?" open ended questions adapted from Jorm (2009).
Timepoint [2] 294173 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [3] 294174 0
Help-seeking of the parent if they developed a mental health problem over last 12 months, "What do you think the problem was? What did you do?" open ended questions adapted from Jorm (2009).
Timepoint [3] 294174 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [4] 294175 0
Mental health of adolescents and parents. A score of equal to or greater than 19 on the K6 Interviewer- Administered 12-month version (Kessler et al., 2003) indicates a high level of psychological distress in the anxiety and depression spectrum.
Timepoint [4] 294175 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [5] 294176 0
Parent's recognition of physical injury needing assistance in 2 first-aid vignettes, 9 multiple choice items based on the Australian Red Cross First Aid course.
Timepoint [5] 294176 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [6] 294177 0
Parent's confidence in assisting an adolescent character in 2 first aid vignettes, based on the Australian Red Cross First Aid course. 5 point Likert scale from 1=very confident to 4=not confident at all, 5 = not sure/don't know.
Timepoint [6] 294177 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [7] 294178 0
First aid actions intended. Parents asked to imagine that the adolescents in the 2 first aid vignettes are their own. "You want to help him/her. What would you do?" Open-ended question based on the Australian Red Cross First Aid course.
Timepoint [7] 294178 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [8] 294179 0
Self-reported supportive behaviours of parents whose adolescent developed a physical health problem or injury over the last 12 months. Open ended questions based on the Australian Red Cross First Aid course.
Timepoint [8] 294179 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [9] 294180 0
Parent's self-reported supportive behaviours over the last 12 months toward a person other than their adolescent, who required first aid. Open ended questions based on the Australian Red Cross First Aid course.
Timepoint [9] 294180 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [10] 294181 0
Parent's knowledge about mental health problems. 18 question true or false quiz based on 2nd ed. Youth Mental Health First Aid manual (Kelly et al., 2010)
Timepoint [10] 294181 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [11] 294182 0
Parent's recognition of mental health problems in 4 vignettes depicting: depression, social phobia, EDNOS and psychosis. "What is wrong with John/Jenny?" (adapted from Jorm et al., 2005; 2007).
Timepoint [11] 294182 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [12] 294183 0
Intention to help in relation to 4 mental health vignettes. Parents asked to imagine vignette character is their adolescent. "You want to help him/her. What would you do?" Adolescents asked, "If you had a problem like John/Jenny would you ask for help? Who would you ask? Where would you go?" (adapted from Kelly et al., 2007).
Timepoint [12] 294183 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [13] 294184 0
Parent's confidence in supporting an adolescent depicted in 4 mental health vignettes (Jorm et al., 2007).
Timepoint [13] 294184 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [14] 294185 0
Personal stigma of parents and adolescents, in relation to character depicted in psychosis vignette. (7 item Personal Stigma Scale, Griffiths et al., 2004).
Timepoint [14] 294185 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [15] 294391 0
Adolescent's help seeking from parent and professionals for mental health problems (adapted from Jorm et al., 2007).
Timepoint [15] 294391 0
at baseline, one-year post and annually up to 8 years post intervention.
Secondary outcome [16] 294392 0
Adolescent's perceptions of general social support from the parent - Communication scale from People in My Life Questionnaire (Armsden & Greenberg, 1992).
Timepoint [16] 294392 0
at baseline, one-year post and annually up to 8 years post intervention.

Eligibility
Key inclusion criteria
Parents of teenagers aged between 12-15 years and their teenagers are invited to participate (one parent and one teenager per family). Minimum age for teenager at baseline: 12 years, for parents: no limit. Maximum age for teenager at baseline: 15 years, for parents: no limit.
Minimum age
12 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone who has undertaken training within the previous three years in the following: Mental Health First Aid (MHFA), Youth MHFA or Apply First Aid (HLTFA301B).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were enrolled via online registration and prompted to choose a date for a telephone survey for themselves and their teenager. Following completion of the online consent form, the parent was prompted to select 2 course dates from a list of courses displayed in two columns. One column contained YMHFA courses, the other contained First Aid courses but columns were not labelled. After selecting one course from each column, the parent was sent an automatic email listing both course dates. Immediately on conclusion of their course selection, the parent was randomized into one of their chosen courses, but not advised as to which course they were randomized into at this stage. Allocation was concealed from the Trial Manager, by computer. Randomization was carried out by a random integer generator programmed on the trial website to give values of 1=Youth MHFA and 2=First Aid (see http://php.net/manual/en/function.rand.php). Participants’ demographics including course randomization were downloaded by the Trial Manager in batches of approx 10 and emailed to the Social Research Centre (SRC) for baseline interview, prior to the parents’ course attendance. At the conclusion of the telephone interview, the parent was advised of their course type and date by the Telephone Interviewer. This was confirmed by email by the Trial Manager.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Software which generated a random integer of 1=YMHFA or 2=First Aid (see http://php.net/manual/en/function.rand.php) was installed on the trial website. The program ran immediately after the parent selected their 2 courses. Course selection was allowed only once (i.e. participants could not change their course dates themselves).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinding of participants to intervention is not possible. However, Interviewers carrying out assessments will be blinded.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA
Recruitment postcode(s) [1] 4790 0
3400
Recruitment postcode(s) [2] 4791 0
3393
Recruitment postcode(s) [3] 4792 0
3550
Recruitment postcode(s) [4] 4793 0
3000
Recruitment postcode(s) [5] 4794 0
3042
Recruitment postcode(s) [6] 4795 0
3051
Recruitment postcode(s) [7] 4796 0
3070
Recruitment postcode(s) [8] 4797 0
3020
Recruitment postcode(s) [9] 4798 0
3016
Recruitment postcode(s) [10] 4799 0
3013
Recruitment postcode(s) [11] 4800 0
3121
Recruitment postcode(s) [12] 4801 0
3044
Recruitment postcode(s) [13] 4802 0
3030
Recruitment postcode(s) [14] 4803 0
3028
Recruitment postcode(s) [15] 4804 0
3032
Recruitment postcode(s) [16] 4805 0
3021
Recruitment postcode(s) [17] 4806 0
3182
Recruitment postcode(s) [18] 4807 0
3036
Recruitment postcode(s) [19] 4808 0
3056
Recruitment postcode(s) [20] 4809 0
3018
Recruitment postcode(s) [21] 4810 0
3047
Recruitment postcode(s) [22] 4811 0
3023
Recruitment postcode(s) [23] 4812 0
3066
Recruitment postcode(s) [24] 4813 0
3068
Recruitment postcode(s) [25] 4814 0
3040
Recruitment postcode(s) [26] 4815 0
3060
Recruitment postcode(s) [27] 4816 0
3065
Recruitment postcode(s) [28] 4817 0
3031
Recruitment postcode(s) [29] 4818 0
3199
Recruitment postcode(s) [30] 4819 0
3220
Recruitment postcode(s) [31] 4820 0
3046
Recruitment postcode(s) [32] 4821 0
3029
Recruitment postcode(s) [33] 4822 0
3053
Recruitment postcode(s) [34] 4823 0
3058
Recruitment postcode(s) [35] 4824 0
3084
Recruitment postcode(s) [36] 4825 0
3052
Recruitment postcode(s) [37] 4826 0
3039
Recruitment postcode(s) [38] 4827 0
3015
Recruitment postcode(s) [39] 4828 0
3174
Recruitment postcode(s) [40] 4829 0
3429
Recruitment postcode(s) [41] 4830 0
3037
Recruitment postcode(s) [42] 4831 0
3074
Recruitment postcode(s) [43] 4832 0
3012
Recruitment postcode(s) [44] 4833 0
3205
Recruitment postcode(s) [45] 4834 0
3073
Recruitment postcode(s) [46] 4835 0
3166
Recruitment postcode(s) [47] 4836 0
3134
Recruitment postcode(s) [48] 4837 0
3206
Recruitment postcode(s) [49] 4838 0
3175
Recruitment postcode(s) [50] 4839 0
3108
Recruitment postcode(s) [51] 4840 0
3002
Recruitment postcode(s) [52] 4841 0
3095
Recruitment postcode(s) [53] 4842 0
3184
Recruitment postcode(s) [54] 9233 0
2000 - Sydney
Recruitment postcode(s) [55] 9234 0
4001 - Brisbane
Recruitment postcode(s) [56] 9235 0
5001 - Adelaide
Recruitment postcode(s) [57] 9236 0
6001 - Perth
Recruitment postcode(s) [58] 9237 0
7001 - Hobart
Recruitment postcode(s) [59] 9238 0
0801 - Darwin
Recruitment postcode(s) [60] 9239 0
2601 - Canberra

Funding & Sponsors
Funding source category [1] 284409 0
Government body
Name [1] 284409 0
National Health and Medical Research Council
Address [1] 284409 0
Level 1
Marcus Clarke Street
CANBERRA ACT 2601
Country [1] 284409 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
School of Population Health, Population Mental Health Group, 207 Bouverie Street CARLTON VIC 3010
Country
Australia
Secondary sponsor category [1] 283339 0
Other Collaborative groups
Name [1] 283339 0
Mental Health First Aid (MHFA) Australia
Address [1] 283339 0
Level 6, 369 Royal Parade, PARKVILLE VIC 3052
Country [1] 283339 0
Australia
Other collaborator category [1] 260407 0
Charities/Societies/Foundations
Name [1] 260407 0
Australian Red Cross
Address [1] 260407 0
23-47 Villiers Street
North Melbourne VIC 3051
Country [1] 260407 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286364 0
Behavioural and Social Sciences Human Ethics Sub-Committee
Ethics committee address [1] 286364 0
The University of Melbourne
Level 5
Alan Gilbert Building
PARKVILLE VIC 3010
Ethics committee country [1] 286364 0
Australia
Date submitted for ethics approval [1] 286364 0
05/08/2011
Approval date [1] 286364 0
02/09/2011
Ethics approval number [1] 286364 0
1135679

Summary
Brief summary
The trial is being led by Professor Anthony Jorm from the School of Population Health, Population Mental Health Group at The University of Melbourne. One thousand families in Victoria are invited to participate, consisting of one parent and one teenager (aged between 12-15 years) per family. Parents will be randomly assigned to either a 14 hour Youth Mental Health First Aid course or a 15 hour Australian Red Cross Apply First Aid course. The study will assess whether parents who are trained in physical or mental health first aid respond differently to teenagers who develop physical or mental health problems. Telephone surveys will be conducted on both the parent and teenager before the parent can attend their free training course. Parents will be asked about their knowledge about mental and physical first aid, confidence in supporting a teenager with a mental or physical health problem and self-reported supportive behaviours if their teenager or someone they know develops a mental or physical health problem and perceptions of their own mental health. Teenagers will be asked about their intentions to seek help and actual help-seeking from family and professionals for mental health problems depicted in vignettes, perceptions of support from the parent if the teenager develops a mental health problem and perceptions of their own mental health and general social support from the parent. Both telephone surveys will ask about stigmatizing attitudes toward mental illness. One year after the initial telephone survey, parents and teenagers will be asked to complete another telephone survey. This will continue on an annual basis, for possibly up to ten years, subject to funding being available. The project has received ethics approval (ID: 1135679) and is funded by a National Health and Medical Research Council Australia Fellowship.
Trial website
www.tpot.net.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33180 0
Prof Anthony Jorm
Address 33180 0
Centre for Mental Health, Melbourne School of Population and Global Health, The University of Melbourne, Level 4, 207 Bouverie Street, Carlton VIC 3010
Country 33180 0
Australia
Phone 33180 0
+61 3 9035 7799
Fax 33180 0
Email 33180 0
ajorm@unimelb.edu.au
Contact person for public queries
Name 16427 0
Ms Julie-Anne Fischer
Address 16427 0
Centre for Mental Health, Melbourne School of Population and Global Health, Level 4, 207 Bouverie Street, CARLTON VIC 3010
Country 16427 0
Australia
Phone 16427 0
+613 9035 6770
Fax 16427 0
+ 613 9349 5815
Email 16427 0
jfischer@unimelb.edu.au
Contact person for scientific queries
Name 7355 0
Prof Anthony Jorm
Address 7355 0
Centre for Mental Health, Melbourne School of Population and Global Health, Level 4, 207 Bouverie Street, CARLTON VIC 3010
Country 7355 0
Australia
Phone 7355 0
+613 9035 7799
Fax 7355 0
+613 9349 5815
Email 7355 0
ajorm@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary