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Trial registered on ANZCTR


Registration number
ACTRN12617001220358
Ethics application status
Approved
Date submitted
17/08/2017
Date registered
21/08/2017
Date last updated
21/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Child/Adolescent and Parent Emotion Regulation (CAPER) Program for At-Risk Youth
Scientific title
A pilot evaluation of the Child /Adolescent and Parent Emotion Regulation (CAPER) Program for at risk youth
Secondary ID [1] 292680 0
NONE
Universal Trial Number (UTN)
U1111-1200-9162
Trial acronym
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
emotion regulation difficulties 304432 0
Condition category
Condition code
Mental Health 303761 303761 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6 week emotion regulation (psychotherapy) intervention will be tested referred to as the CAPER program.

The CAPER program will be individually administered and conducted in-person (face to face) delivery mode. All participants must attend the Centre for Emotional Health Clinic at Macquarie University, Sydney.

Each session is of 60 minutes duration in total. Sessions 1 to 5 are conducted on consecutive weeks, whilst the final 6th session is conducted 2-weeks after the 5th session.
The first and final (6th) sessions are parent only-sessions, whilst sessions 2 through to 5 are child-sessions in which the parent/s will also be asked to attend.

The CAPER program aims to teach parents and their children emotion regulatory skills based on cognitive and behavioural strategies. The program is manualised and will be conducted by registered psychologists. Supervision to the psychologists will be conducted by the Chief Investigator (CI), Assoc.Professor Kangas who is a registered Clinical Psychologist.

Following parental/child consent, therapy sessions will be taped and a random proportion (30%) will be selected to be reviewed by the CI for treatment fidelity checks (i.e, to ensure therapists are adhering to the manualised content of the CAPER program).

All participants (child-parent dyads) before commencing the CAPER program will be required to complete the baseline (T1) initial assessment, They will then be asked to complete a daily mood diary for 18 consecutive days before being invited to complete a 2nd (T2) assessment. Following the 2nd (T2) assessment, parent-child dyads will commence the CAPER program.
Intervention code [1] 298914 0
Behaviour
Intervention code [2] 298921 0
Treatment: Other
Comparator / control treatment
No control group
This is an initial pilot (proof-of-concept) trial using an A/B design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303126 0
Emotional Awareness Questionnaire (Child)



Timepoint [1] 303126 0
Baseline (T1)
Time 2 (T2) - 3 weeks follow-up baseline (T1) and prior to commencing the therapy program
Time 3(T3) - end of therapy
Time 4 (T4) - 1-month follow-up
Primary outcome [2] 303130 0
Emotion Regulation Questionnaire (Child and Adult versions)
[NB - Both children and adults will be asked to complete the appropriate version of this measure]
Timepoint [2] 303130 0
Baseline (T1)
Time 2 (T2) - 3 weeks follow-up baseline (T1) and prior to commencing the therapy program
Time 3(T3) - end of therapy
Time 4 (T4) - 1-month follow-up
Primary outcome [3] 303131 0
Cognitive Emotion Regulation Questionnaire (CERQ-18) (child and adult versions)
[NB - Both children and adults will be asked to complete the appropriate version of this measure]
Timepoint [3] 303131 0
Baseline (T1)
Time 2 (T2) - 3 weeks follow-up baseline (T1) and prior to commencing the therapy program
Time 3(T3) - end of therapy
Time 4 (T4) - 1-month follow-up
Secondary outcome [1] 337975 0
Anger Expression Scale for Children (AES)
Timepoint [1] 337975 0
Baseline (T1)
Time 2 (T2) - 3 weeks follow-up baseline (T1) and prior to commencing the therapy program
Time 3(T3) - end of therapy
Time 4 (T4) - 1-month follow-up
Secondary outcome [2] 337976 0
Schedule for Affective Disorders (Kiddie –SADS) – DSM-5 version
Timepoint [2] 337976 0
Baseline (T1)
Time 2 (T2) - 3 weeks follow-up baseline (T1) and prior to commencing the therapy program
Time 3(T3) - end of therapy
Time 4 (T4) - 1-month follow-up
Secondary outcome [3] 337977 0
Child Behavior Check List (CBCL)
Timepoint [3] 337977 0
Baseline (T1)
Time 2 (T2) - 3 weeks follow-up baseline (T1) and prior to commencing the therapy program
Time 3(T3) - end of therapy
Time 4 (T4) - 1-month follow-up
Secondary outcome [4] 337978 0
Emotional Self-Efficacy Scale (Child and Adult versions)
[NB - Both children and adults will be asked to complete the appropriate version of this measure]
Timepoint [4] 337978 0
Baseline (T1)
and
Time 4 (T4) - 1-month follow-up
Secondary outcome [5] 337979 0
Parental Sense-Of-Competency Scale
Timepoint [5] 337979 0
Baseline (T1)
and
Time 4 (T4) - 1-month follow-up
Secondary outcome [6] 337980 0
Family Conflict Scale (parent only)
Timepoint [6] 337980 0
Baseline (T1)
Time 2 (T2) - 3 weeks follow-up baseline (T1) and prior to commencing the therapy program
Time 3(T3) - end of therapy
Time 4 (T4) - 1-month follow-up
Secondary outcome [7] 337981 0
Alabama Parenting Questionnaire - Short form (APQ - 9)
Timepoint [7] 337981 0
Baseline (T1)
Time 2 (T2) - 3 weeks follow-up baseline (T1) and prior to commencing the therapy program
Time 3(T3) - end of therapy
Time 4 (T4) - 1-month follow-up
Secondary outcome [8] 337982 0
Depression Anxiety Stress Scale (DASS-21) (Parents only)
Timepoint [8] 337982 0
Baseline (T1)
Time 2 (T2) - 3 weeks follow-up baseline (T1) and prior to commencing the therapy program
Time 3(T3) - end of therapy
Time 4 (T4) - 1-month follow-up

Eligibility
Key inclusion criteria
1) Child must be aged 6 to 14 years of age
2) Child has demonstrated emotion regulation difficulties on a regular basis over the past 4 weeks (e.g., acting out, struggling to manage or expressive emotions)
3) Is able to speak and understand English
4) At least one parent/caregiver is committed to attending the therapy sessions in conjunction with the child.
Minimum age
6 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Meets full diagnostic criteria for any psychiatric disorder
(2) Current suicidal ideation or self harm behaviours.

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)
Not applicable as this is a non-RCT.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
An A-B design is being used.
1) All participants (child/parent) dyads complete baseline (T1) initial assessment.
2) Eligible participants complete an 18-daily diary period
3) Participants complete a 2nd (T2) Assessment - 3 weeks after T1
4) CAPER program is delivered
5) T3 Assessment - 1-week after the 6th & final therapy session
6) T4 Assessment - 1 -month follow-up.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Paired t-tests and within subject Anovas for testing main effects
Regression analyses for testing potential predictors

Recruitment
Recruitment status
Not yet 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)
NSW
Recruitment postcode(s) [1] 16954 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 297319 0
University
Name [1] 297319 0
Macquarie University Staff Grant (Restart)
Address [1] 297319 0
Macquarie University,
Building C3A #717
NSW 2109,
Australia
Country [1] 297319 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University,
Building C3A #717
NSW 2109,
Australia
Country
Australia
Secondary sponsor category [1] 296290 0
None
Name [1] 296290 0
Address [1] 296290 0
Country [1] 296290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298421 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 298421 0
Macquarie University,
NSW 2109,
Australia
Ethics committee country [1] 298421 0
Australia
Date submitted for ethics approval [1] 298421 0
11/04/2017
Approval date [1] 298421 0
31/05/2017
Ethics approval number [1] 298421 0
5201700438

Summary
Brief summary
The objective of the current study is to develop and evaluate an emotion regulation (ER) child and parental treatment program for children and adolescents (aged 6 to 14 years) who are experiencing ER difficulties as evidenced by recurring emotional/anger outbursts and impulsive maladaptive behaviours. Specifically, the objective is to conduct a proof-of-concept, pilot ER intervention study for at-risk youth of developing chronic internalising and/or externalising disorders.
Primary Aim: To develop and test the efficacy of an individual, 6-session, ER child and parental program using an A-B design with a one-month follow-up. The manualized intervention will comprise a) parental training specific components (initial/ session 1 and final/booster Session 6) and child/ adolescent with active parental dyadic intervention phase (4 sessions; conducted weeks 2 to 5).

Trial website
https://tinyurl.com/CAPER-program
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77034 0
A/Prof Maria Kangas
Address 77034 0
Centre for Emotional Health,
Department of Psychology | Level 7, 717, C3A Building
Macquarie University, NSW 2109, Australia
Country 77034 0
Australia
Phone 77034 0
+61298508599
Fax 77034 0
Email 77034 0
maria.kangas@mq.edu.au
Contact person for public queries
Name 77035 0
A/Prof Maria Kangas
Address 77035 0
Centre for Emotional Health,
Department of Psychology | Level 7, 717, C3A Building
Macquarie University, NSW 2109, Australia
Country 77035 0
Australia
Phone 77035 0
+ 61 2 98508599
Fax 77035 0
Email 77035 0
maria.kangas@mq.edu.au
Contact person for scientific queries
Name 77036 0
A/Prof Maria Kangas
Address 77036 0
Centre for Emotional Health,
Department of Psychology | Level 7, 717, C3A Building
Macquarie University, NSW 2109, Australia
Country 77036 0
Australia
Phone 77036 0
+ 61 2 98508599
Fax 77036 0
Email 77036 0
maria.kangas@mq.edu.au

No data has been provided for results reporting
Summary results
Not applicable