Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000393550
Ethics application status
Approved
Date submitted
31/08/2006
Date registered
6/09/2006
Date last updated
6/09/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Parent Transition Program
Scientific title
A longitudinal Interpersonal Psycho-Therapeutic group treatment targeting parental interpersonal problems to improve mood and general health.
Universal Trial Number (UTN)
Trial acronym
PTP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression and Interpersonal problems (loss & grief, interpersonal disputes, social isolation, role transitions). 1359 0
Condition category
Condition code
Mental Health 1451 1451 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A longitudianal Interpersonal Psycho-Therapy program targeting mild to moderate parental mental health problems.

Treatment aims to help parents adjust to a new life role and better manage the difficulties that arise from parenting. It is conducted in a group and runs for 3 hours per week over a six week period.

The program does not assume that all parenting issues are solely caused from interpersonal problems. However, a dynamic interplay occurs between interpersonal, biological and personality factors.
Intervention code [1] 1338 0
Behaviour
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2001 0
Parental psychosocial functioning.

Measured by the Depression Anxiety Stress Scales (DASS: Lovibond & Lovibond, 1995), the General Health Questionaire and the Abbreviated Dyadic Adjustment Scale (ADAS: Shapley & Rogers, 1984).
Timepoint [1] 2001 0
Outcome measures will be taken a baseline (just before), at the end (week 6) and 3 mths post treatment.
Primary outcome [2] 2002 0
Social adjustment.

Measured by the Depression Anxiety Stress Scales (DASS: Lovibond & Lovibond, 1995), the General Health Questionaire and the Abbreviated Dyadic Adjustment Scale (ADAS: Shapley & Rogers, 1984).
Timepoint [2] 2002 0
Outcome measures will be taken a baseline (just before), at the end (week 6) and 3 mths post treatment.
Primary outcome [3] 2003 0
General health.

Measured by the Depression Anxiety Stress Scales (DASS: Lovibond & Lovibond, 1995), the General Health Questionaire and the Abbreviated Dyadic Adjustment Scale (ADAS: Shapley & Rogers, 1984).
Timepoint [3] 2003 0
Outcome measures will be taken a baseline (just before), at the end (week 6) and 3 mths post treatment.
Secondary outcome [1] 3469 0
1) Increased positive parental behaviours will be measures by the Parent Problem Checklist (PPC: Dadds & Powell, 1991), the Parenting Scale (PS: Arnold, O’Leary, Wolff & Acker, 1993) and the Parenting Sense of Competence Scale (PSOC: Gibaud & Wallston, 1978.
Timepoint [1] 3469 0
Outcome measures will be taken a baseline (just before), at the end (week 6) and 3 mths post treatment.
Secondary outcome [2] 3470 0
2) Decreased child behaviour problems will be measured by the Eyberg Child Behaviour Inventory (ECBI: Eyberg & Pincus, 1998).
Timepoint [2] 3470 0
Outcome measures will be taken a baseline (just before), at the end (week 6) and 3 mths post treatment.
Secondary outcome [3] 3471 0
3) Participant satisfaction
Timepoint [3] 3471 0
Measured by a satisfaction questionnaire issued at the end (week 6) and at 3 mth post treatment.

Eligibility
Key inclusion criteria
1) are parents with children at home, 2) live in the Gold Coast Health Service District, 3) report mild to moderate mental health problems ie depresion, interpersoanl problems, loss and grief.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have current psychotic symptoms, have severe substance abuse, do not have children at home and if they live outside the Gold Coast Health Service District .

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1588 0
Government body
Name [1] 1588 0
Queensland Department of Health
Country [1] 1588 0
Australia
Primary sponsor type
Government body
Name
Gold Coast Community Child Health
Address
Country
Australia
Secondary sponsor category [1] 1395 0
Individual
Name [1] 1395 0
Kim LeGros
Address [1] 1395 0
Country [1] 1395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3011 0
Queensland Healths Gold Coast Hospital Ethics Committee-Gold Coast Health Service District
Ethics committee address [1] 3011 0
Ethics committee country [1] 3011 0
Australia
Date submitted for ethics approval [1] 3011 0
Approval date [1] 3011 0
Ethics approval number [1] 3011 0
200336

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

Contacts
Principal investigator
Name 27945 0
Address 27945 0
Country 27945 0
Phone 27945 0
Fax 27945 0
Email 27945 0
Contact person for public queries
Name 10527 0
Kim LeGros
Address 10527 0
23 LeMans Drive
Broadbeach
Gold Coast QLD 4218
Country 10527 0
Australia
Phone 10527 0
+61 7 55261327
Fax 10527 0
+61 7 55261328
Email 10527 0
[email protected]
Contact person for scientific queries
Name 1455 0
Kim LeGros
Address 1455 0
23 LeMans Drive
Broadbeach
Gold Coast QLD 4218
Country 1455 0
Australia
Phone 1455 0
+61 7 55261327
Fax 1455 0
+61 7 55261328
Email 1455 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.