Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000668707
Ethics application status
Approved
Date submitted
11/06/2013
Date registered
19/06/2013
Date last updated
24/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Family intervention for adolescents with suicidal behaviour: A randomized controlled trial and mediation analysis.
Scientific title
A randomized controlled trial evaluating the efficacy of combining the Resourceful Adolescent Parent Program (RAP-P) and Routine Care, as compared to Routine Care only, in reducing suicidal behaviour and psychiatric disability in adolescents aged 12-17 years old
Secondary ID [1] 282621 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidality 289313 0
Psychiatric disability 289314 0
Condition category
Condition code
Mental Health 289651 289651 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resourceful Adolescent Parent Program (RAP-P) plus Routine Care. RAP-P is a strengths-based family education program developed to build resilience and promote positive mental health in adolescents. This interactive psycho-education program consists of four x 2 hour face-to-face sessions with a therapist that were conducted weekly or fortnightly depending on parents availability to attend. The sessions involve an introduction to, and information about self-injurious behaviour , identification of parental strengths, information and strategies around adolescent development, and the provision of strategies to promote family harmony and manage conflict. Those undergoing the RAP-P also receive Routine Care as per the control group. Routine care consisted of any intervention deemed necessary by the adolescent’s treating team other than the family intervention program trialled in this study. This includes combinations of crisis management, safety planning, individual psycho-education, non-specific counselling, supportive therapy, cognitive behaviour therapy and pharmacological treatment. The duration of the intervention phase was 4-8 weeks depending on session frequency with a follow-up assessment taking place 6 months after the intervention.
Intervention code [1] 287287 0
Treatment: Other
Comparator / control treatment
Routine Care only. Any intervention deemed necessary by the adolescent’s treating team other than the family intervention program trialled in this study. This includes combinations of crisis management, safety planning, individual psycho-education, non-specific counselling, supportive therapy, cognitive behaviour therapy and pharmacological treatment.
Control group
Active

Outcomes
Primary outcome [1] 289730 0
Adolescent suicidal symptoms as measured by the Adolescent Suicide Questionnaire - Revised (ASQ-R)
Timepoint [1] 289730 0
Pre-treatment, 3-month follow-up, 6-month follow-up
Primary outcome [2] 289731 0
General psychological adjustment as measured by the Strengths and Difficulties Questionnaire (SDQ) and the Health of the Nation Outcomes Scale for Children and Adolescents (HoNOSCA)
Timepoint [2] 289731 0
Pre-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [1] 303118 0
Family adjustment as measured by the Family Assessment Device (FAD) - adolescent-rated and parent-rated
Timepoint [1] 303118 0
Pre-treatment, 3-month follow-up, 6-month follow-up

Eligibility
Key inclusion criteria
Adolescents aged between 12-17 years old; had engaged in at least one episode of suicidal behaviour (includes suicidal ideation, intent or attempt, deliberate self-inflicted injurious behaviour) within the last 2 months prior to their referral; were residing with at least one parent (biological or adoptive); their primary diagnosis included any of the following: Major Depression, Post-Trauma Stress Disorder, or Anxiety disorder (based on DSM-IV classification)
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychoses and developmental disorders were excluded.

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)
Randomisation was done on an individual basis by an intake officer who was not involved in the study using random binary number codes to ensure concealed allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size was sufficient to detect the effect size from a previous study (Diamond et al.) for two groups over three time points at p = .05 and power = .95 (G-Power v.3.1.5).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1080 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 1081 0
Mount Druitt Hospital - Mount Druitt
Recruitment postcode(s) [1] 6939 0
2148 - Blacktown
Recruitment postcode(s) [2] 6940 0
2770 - Mount Druitt

Funding & Sponsors
Funding source category [1] 287398 0
Self funded/Unfunded
Name [1] 287398 0
Country [1] 287398 0
Primary sponsor type
Individual
Name
Professor Mark Dadds
Address
School of Psychology
University of New South Wales
Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 286139 0
Individual
Name [1] 286139 0
Jane Pineda
Address [1] 286139 0
Blacktown Early Access Team (BEAT)
Headspace Mount Druitt Building
6-10 Mount Street, Mount Druitt NSW 2770, Australia
TBC
Country [1] 286139 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289376 0
Sydney West Area Health Service - Human Research Ethics Committee
Ethics committee address [1] 289376 0
Ethics committee country [1] 289376 0
Australia
Date submitted for ethics approval [1] 289376 0
14/02/2005
Approval date [1] 289376 0
12/05/2005
Ethics approval number [1] 289376 0
HREC2005/3/4.11(2050)
Ethics committee name [2] 289411 0
UNSW Human Research Ethics Committee
Ethics committee address [2] 289411 0
Ethics committee country [2] 289411 0
Australia
Date submitted for ethics approval [2] 289411 0
Approval date [2] 289411 0
27/02/2006
Ethics approval number [2] 289411 0
HREC05347

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

Contacts
Principal investigator
Name 40534 0
Ms Jane Pineda
Address 40534 0
Blacktown Early Access Team (BEAT)
Headspace Mount Druitt Building
6-10 Mount Street, Mount Druitt NSW 2770, Australia
Country 40534 0
Australia
Phone 40534 0
+61 2 88875600
Fax 40534 0
Email 40534 0
[email protected]
Contact person for public queries
Name 40535 0
Mark Dadds
Address 40535 0
School of Psychology
University of New South Wales
Sydney, NSW 2052
Country 40535 0
Australia
Phone 40535 0
+61 2 93853538
Fax 40535 0
Email 40535 0
[email protected]
Contact person for scientific queries
Name 40536 0
Mark Dadds
Address 40536 0
School of Psychology
University of New South Wales
Sydney, NSW 2052
Country 40536 0
Australia
Phone 40536 0
+61 2 93853538
Fax 40536 0
Email 40536 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
No additional documents have been identified.