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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]

NONE

Universal Trial Number (UTN)

U1111-1200-9162

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

emotion regulation difficulties

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

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]

Emotional Awareness Questionnaire (Child)

Timepoint [1]

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]

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]

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]

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]

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]

Anger Expression Scale for Children (AES)

Timepoint [1]

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]

Schedule for Affective Disorders (Kiddie –SADS) – DSM-5 version

Timepoint [2]

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]

Child Behavior Check List (CBCL)

Timepoint [3]

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]

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]

Baseline (T1)
and
Time 4 (T4) - 1-month follow-up

Secondary outcome [5]

Parental Sense-Of-Competency Scale

Timepoint [5]

Baseline (T1)
and
Time 4 (T4) - 1-month follow-up

Secondary outcome [6]

Family Conflict Scale (parent only)

Timepoint [6]

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]

Alabama Parenting Questionnaire - Short form (APQ - 9)

Timepoint [7]

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]

Depression Anxiety Stress Scale (DASS-21) (Parents only)

Timepoint [8]

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

Sex

Both males and females

Can healthy volunteers participate?

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)

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

28/08/2017

Actual

Date of last participant enrolment

Anticipated

27/10/2017

Actual

Date of last data collection

Anticipated

2/03/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2109 - Macquarie University

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University Staff Grant (Restart)

Address [1]

Macquarie University,
Building C3A #717
NSW 2109,
Australia

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Macquarie University,
Building C3A #717
NSW 2109,
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee

Ethics committee address [1]

Macquarie University, 
NSW 2109, 
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/04/2017

Approval date [1]

31/05/2017

Ethics approval number [1]

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

A/Prof Maria Kangas

Address

Centre for Emotional Health,
Department of Psychology | Level 7, 717, C3A Building
Macquarie University, NSW 2109, Australia

Country

Australia

Phone

+61298508599

Fax

maria.kangas@mq.edu.au

Contact person for public queries

Name

Maria Kangas

Address

Centre for Emotional Health,
Department of Psychology | Level 7, 717, C3A Building
Macquarie University, NSW 2109, Australia

Country

Australia

Phone

+ 61 2 98508599

Fax

maria.kangas@mq.edu.au

Contact person for scientific queries

Name

Maria Kangas

Address

Centre for Emotional Health,
Department of Psychology | Level 7, 717, C3A Building
Macquarie University, NSW 2109, Australia

Country

Australia

Phone

+ 61 2 98508599

Fax

maria.kangas@mq.edu.au

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.

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