Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000594426
Ethics application status
Approved
Date submitted
2/02/2025
Date registered
10/06/2025
Date last updated
10/06/2025
Date data sharing statement initially provided
10/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a Parenting Program on Distressed Jordanian Children
Scientific title
Randomised Controlled Trial of the Effect of a Parenting Program on Mental Health in Jordanian Children Experiencing Distress
Secondary ID [1] 313860 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 336524 0
Depression 336525 0
Condition category
Condition code
Mental Health 333029 333029 0 0
Anxiety
Mental Health 333030 333030 0 0
Depression
Mental Health 333031 333031 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1 is the intervention arm, and comprises a program titled Problem Management Plus Parenting (PM+P), which involves once-weekly 90 minute sessions delivered by a facilitator over 7 weeks delivered to groups of 8-10 parents at a time. PM+P will teach the following parenting strategies: effective communication, problem solving, positive reinforcement, and alternatives to harsh punitive parenting practices. Facilitators will be local non-specialist psychosocial workers trained face-to-face in Jordan by the authors of the program over 10 full days conducted 1 month prior to commencement of the trial. Facilitators will receive supervision through the trial. Sessions will be conducted in clinics in Jordan. Treatment adherence will be assessed by facilitators monitoring session attendance. Arm 1 participants will receive 7 weeks of intervention and 52 weeks of follow-up assessment, resulting in a total participation duration of 62 weeks.
Intervention code [1] 330448 0
Behaviour
Intervention code [2] 330449 0
Treatment: Other
Comparator / control treatment
Arm 2 is the control condition. This arm comprises Enhanced Treatment as Usual, which comprises providing parents with feedback approximately one week after the baseline assessment about their child's mental health via a single 15-minute phone call conducted by trained nonspecialist research assistants, and subsequently they are sent a link via their phone that lists details to local psychosocial services that can provide direct assistance. Arm 2 participants will receive the baseline assessment, and the same assessments as participants in Arm 1, resulting in a total participation duration of 62 weeks.
Control group
Active

Outcomes
Primary outcome [1] 340574 0
Children's internalising symptoms (anxiety)
Timepoint [1] 340574 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).
Primary outcome [2] 341315 0
Children's internalising symptoms (depression)
Timepoint [2] 341315 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).
Secondary outcome [1] 444487 0
Parents' report of child's anxiety
Timepoint [1] 444487 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).
Secondary outcome [2] 444488 0
Revised Child Anxiety and Depression Scale (depression subscale) - Parent Report version
Timepoint [2] 444488 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).
Secondary outcome [3] 444489 0
Parent's mental health
Timepoint [3] 444489 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).
Secondary outcome [4] 444490 0
Parent's parenting behaviour
Timepoint [4] 444490 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).
Secondary outcome [5] 446842 0
Child wellbeing
Timepoint [5] 446842 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).
Secondary outcome [6] 446843 0
Child's externalising problems
Timepoint [6] 446843 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).
Secondary outcome [7] 446844 0
Nature of relationship between child and parent
Timepoint [7] 446844 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).
Secondary outcome [8] 448571 0
Child's sense of family support
Timepoint [8] 448571 0
Pretreatment (week 1), post-PM+P or EUC (week 9), primary follow-up (week 30), additional follow-up (week 62).

Eligibility
Key inclusion criteria
(a) Resident of Jordan
(b) aged 10-14 years
(c) residing with a related caregiver who could provide legal consent and participate in the trial
(d) scored at least 15 on the Paediatric Symptom Scale (PSC-17)
(e) caregiver willing to attend the group program
Minimum age
10 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) imminent risk of suicide
(b) significant developmental, cognitive, or neurological impairments as determined by four items from an adapted version of the Ten Questions instrument

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)
Participants will be adults indicating moderate distress. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the study and who works at a site that is independent from the trial centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses of the RCT data will focus on intent-to-treat using hierarchical linear models to study treatment effects. Multiple imputation methods will be used to manage missing data. Models will include time-of-assessment point, treatment condition, and their interaction. Fixed (intervention, time of assessment) effects and their interactions will be entered in unstructured models to yield indices of the relative effects of the treatments; time of assessment included baseline, posttreatment, 3-month, and 12-month follow-up.
Fixed effects parameters will be tested with the Wald test (t-test, p <.05, two-sided) and 95% confidence intervals. Analyses will focus on the primary and secondary outcomes. To determine the robustness of this approach, we will repeat the analyses focusing only on participants who complete the 3-month assessment, as well as further sensitivity analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
19/01/2027
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 26857 0
Jordan
State/province [1] 26857 0

Funding & Sponsors
Funding source category [1] 318326 0
Government body
Name [1] 318326 0
NHMRC
Country [1] 318326 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Country
Australia
Secondary sponsor category [1] 320721 0
None
Name [1] 320721 0
Address [1] 320721 0
Country [1] 320721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316961 0
University of Jordan Ethics Committee
Ethics committee address [1] 316961 0
Ethics committee country [1] 316961 0
Jordan
Date submitted for ethics approval [1] 316961 0
10/02/2025
Approval date [1] 316961 0
07/04/2025
Ethics approval number [1] 316961 0

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

Contacts
Principal investigator
Name 139578 0
Prof Richard Bryant
Address 139578 0
School of Psychology University of New South Wales Sydney NSW 2052
Country 139578 0
Australia
Phone 139578 0
+61 293853640
Fax 139578 0
Email 139578 0
[email protected]
Contact person for public queries
Name 139579 0
Richard Bryant
Address 139579 0
School of Psychology University of New South Wales Sydney NSW 2052
Country 139579 0
Australia
Phone 139579 0
+61 293853640
Fax 139579 0
Email 139579 0
[email protected]
Contact person for scientific queries
Name 139580 0
Richard Bryant
Address 139580 0
School of Psychology University of New South Wales Sydney NSW 2052
Country 139580 0
Australia
Phone 139580 0
+61 293853640
Fax 139580 0
Email 139580 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All treatment-related data, assessment data, and related data dictionaries will be available.

What types of analyses could be done with individual participant data?
• Meta-analyses or re-analyses of subgroups.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

• By emailing the Principal Investigator (email: [email protected]).

Are there extra considerations when requesting access to individual participant data?
No


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.