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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

14/10/2021

Date data sharing statement initially provided

14/10/2021

Date results information initially provided

14/10/2021

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]

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.

Parents' confidence in supporting an adolescent child with a mental health problem.

Parents' self-reported supportive behaviours if their adolescent child develops a mental health problem.

Adolescents' intentions to seek help from family and professionals for mental health problems.

Adolescents' help-seeking from the parent for mental health problems.

Adolescents' help-seeking from professionals for mental health problems.

Adolescents' perceptions of support from the parent if the adolescent develops a mental health problem.

Adolescents' perceptions of general social support from the parent.

Mental health of the child.

Parents' supportive behaviours towards people (other than their children) with a mental health problem.

Help-seeking of the parent if the parent has a mental health problem.

Mental health of the parent.

Confidence in assisting an adolescent child with an injury needing assistance.

First aid actions towards an adolescent child with an injury needing assistance.

First aid actions towards people (other than the child) with an injury needing assistance.

Condition category

Condition code

Public Health

Health promotion/education

Mental Health

Depression

Injuries and Accidents

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]

Prevention

Intervention code [2]

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]

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]

at baseline, one-year post and annually up to 8 years post intervention (till Dec 2020).

Primary outcome [2]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Primary outcome [3]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [1]

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]

at baseline, one-year post and annually for up to 8 years post intervention.

Secondary outcome [2]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [3]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [4]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [5]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [6]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [7]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [8]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [9]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [10]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [11]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [12]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [13]

Parent's confidence in supporting an adolescent depicted in 4 mental health vignettes (Jorm et al., 2007).

Timepoint [13]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [14]

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]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [15]

Adolescent's help seeking from parent and professionals for mental health problems (adapted from Jorm et al., 2007).

Timepoint [15]

at baseline, one-year post and annually up to 8 years post intervention.

Secondary outcome [16]

Adolescent's perceptions of general social support from the parent - Communication scale from People in My Life Questionnaire (Armsden & Greenberg, 1992).

Timepoint [16]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

24/10/2011

Actual

24/10/2011

Date of last participant enrolment

Anticipated

31/07/2015

Actual

31/03/2016

Date of last data collection

Anticipated

30/04/2019

Actual

30/04/2019

Sample size

Target

2000

Accrual to date

Final

768

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA

Recruitment postcode(s) [1]

3400

Recruitment postcode(s) [2]

3393

Recruitment postcode(s) [3]

3550

Recruitment postcode(s) [4]

3000

Recruitment postcode(s) [5]

3042

Recruitment postcode(s) [6]

3051

Recruitment postcode(s) [7]

3070

Recruitment postcode(s) [8]

3020

Recruitment postcode(s) [9]

3016

Recruitment postcode(s) [10]

3013

Recruitment postcode(s) [11]

3121

Recruitment postcode(s) [12]

3044

Recruitment postcode(s) [13]

3030

Recruitment postcode(s) [14]

3028

Recruitment postcode(s) [15]

3032

Recruitment postcode(s) [16]

3021

Recruitment postcode(s) [17]

3182

Recruitment postcode(s) [18]

3036

Recruitment postcode(s) [19]

3056

Recruitment postcode(s) [20]

3018

Recruitment postcode(s) [21]

3047

Recruitment postcode(s) [22]

3023

Recruitment postcode(s) [23]

3066

Recruitment postcode(s) [24]

3068

Recruitment postcode(s) [25]

3040

Recruitment postcode(s) [26]

3060

Recruitment postcode(s) [27]

3065

Recruitment postcode(s) [28]

3031

Recruitment postcode(s) [29]

3199

Recruitment postcode(s) [30]

3220

Recruitment postcode(s) [31]

3046

Recruitment postcode(s) [32]

3029

Recruitment postcode(s) [33]

3053

Recruitment postcode(s) [34]

3058

Recruitment postcode(s) [35]

3084

Recruitment postcode(s) [36]

3052

Recruitment postcode(s) [37]

3039

Recruitment postcode(s) [38]

3015

Recruitment postcode(s) [39]

3174

Recruitment postcode(s) [40]

3429

Recruitment postcode(s) [41]

3037

Recruitment postcode(s) [42]

3074

Recruitment postcode(s) [43]

3012

Recruitment postcode(s) [44]

3205

Recruitment postcode(s) [45]

3073

Recruitment postcode(s) [46]

3166

Recruitment postcode(s) [47]

3134

Recruitment postcode(s) [48]

3206

Recruitment postcode(s) [49]

3175

Recruitment postcode(s) [50]

3108

Recruitment postcode(s) [51]

3002

Recruitment postcode(s) [52]

3095

Recruitment postcode(s) [53]

3184

Recruitment postcode(s) [54]

2000 - Sydney

Recruitment postcode(s) [55]

4001 - Brisbane

Recruitment postcode(s) [56]

5001 - Adelaide

Recruitment postcode(s) [57]

6001 - Perth

Recruitment postcode(s) [58]

7001 - Hobart

Recruitment postcode(s) [59]

0801 - Darwin

Recruitment postcode(s) [60]

2601 - Canberra

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
Marcus Clarke Street
CANBERRA ACT 2601

Country [1]

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]

Other Collaborative groups

Name [1]

Mental Health First Aid (MHFA) Australia

Address [1]

Level 6, 369 Royal Parade, PARKVILLE VIC 3052

Country [1]

Australia

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Australian Red Cross

Address [1]

23-47 Villiers Street
North Melbourne VIC 3051

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Behavioural and Social Sciences Human Ethics Sub-Committee

Ethics committee address [1]

The University of Melbourne
Level 5
Alan Gilbert Building
PARKVILLE VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/08/2011

Approval date [1]

02/09/2011

Ethics approval number [1]

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

Prof Anthony Jorm

Address

Centre for Mental Health, Melbourne School of Population and Global Health, The University of Melbourne, Level 4, 207 Bouverie Street, Carlton VIC 3010

Country

Australia

Phone

+61 3 9035 7799

Fax

[email protected]

Contact person for public queries

Name

Dr Amy Morgan

Address

Centre for Mental Health, Melbourne School of Population and Global Health, Level 4, 207 Bouverie Street, CARLTON VIC 3010

Country

Australia

Phone

+61390357711

Fax

+ 613 9349 5815

[email protected]

Contact person for scientific queries

Name

Prof Anthony Jorm

Address

Centre for Mental Health, Melbourne School of Population and Global Health, Level 4, 207 Bouverie Street, CARLTON VIC 3010

Country

Australia

Phone

+613 9035 7799

Fax

+613 9349 5815

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Study results article	Yes	Published on 27 March 2019 Morgan, A.J., Fischer,... [More Details]	347502-(Uploaded-13-05-2021-09-46-58)-Journal results publication.pdf
Study results article	Yes	Morgan, A. J., Fischer, J.-A. A., Hart, L. M., Kel... [More Details]	347502-(Uploaded-13-05-2021-09-46-26)-Journal results publication.pdf
Basic results	No		347502-(Uploaded-13-05-2021-09-53-15)-Basic results summary.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Long-term effects of Youth Mental Health First Aid training: Randomized controlled trial with 3-year follow-up.	2020	https://dx.doi.org/10.1186/s12888-020-02860-1
Embase	Does Mental Health First Aid training improve the mental health of aid recipients? the training for parents of teenagers randomised controlled trial.	2019	https://dx.doi.org/10.1186/s12888-019-2085-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically