Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000155897
Ethics application status
Not yet submitted
Date submitted
2/02/2012
Date registered
3/02/2012
Date last updated
23/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Emotional Engagement Treatment for Disruptive Children with Callous-Unemotional Traits
Scientific title
The efficacy of Emotional Engagement Treatment in reducing disruptive behavior in children with Oppositional Defiant Disorder or Conduct Disorder with Callous-Unemotional Traits
Secondary ID [1] 273363 0
Nil
Universal Trial Number (UTN)
U1111-1125-7298
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oppositional Defiant Disorder (with callous-unemotional traits) 279139 0
Conduct Disorder (with callous-unemotional traits) 279140 0
Condition category
Condition code
Mental Health 279329 279329 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Emotional Engagement (EE) Treatment: EE treatment focuses on the affective dimension of parent-child relations, and is designed to be administered as a brief adjunct to best practice interventions for disruptive children (e.g., Behavioral Family Intervention). It has been created specifically to boost warmth in parent-child relationships, and remediate deficits in eye contact by enhancing the salience of the eyes for high CU children. The treatment involves parents engaging in simple love interactions with their children. Specifically, parents will gently look into their child’s eyes, help the child to return their gaze, and tell the child that they love them. Each interaction is recorded, and reviewed with a therapist such that parents can discuss their experience, and set goals for improvement. Parents are also required to practice Emotional Engagement exercises with the child every day, and are provided with a list of activities they can use at home.

Behavioural Family Intervention Program - The ‘Integrated Family Intervention for Child Conduct Problems’ (Dadds & Hawes, 2006) program will be administered. It focuses on managing child aggression, non-compliance and disruptive behaviour. It aims to modify unhealthy parenting practices by targeting negative reinforcement contingencies operating in the family. Parents are taught to encourage good behaviour by giving positive reinforcement and rewards, and discourage bad behaviour through the provision of consistent, emotionally neutral punishment. The program consists of other modules (parental mental health, marital adjustment, family communication) which can be administered if needed. The program is administered by a clinical psychologist to one or both parents/primary caregivers.

Duration: The EE treatment will be administered in conjuction with a Behavioural Family Intervention (BFI Program. The BFI program is conducted over six weekly 1.5 hour sessions. Each EE session will take place directly after each BFI session. EE sessions will take approximately 15 minutes.
Intervention code [1] 283705 0
Treatment: Other
Intervention code [2] 284186 0
Behaviour
Comparator / control treatment
Child Centered Play (CCP): CCP is a well-established parenting strategy designed to help children be more independent. It involves teaching parents to play with their children in a non directive way. For example, letting the child direct play, following their lead, commentating their actions and not being prescriptive. These practices increase child autonomy, independent learning skills and creativity. Each play interaction is recorded, and reviewed with a therapist such that parents can discuss their experience, and set goals for improvement. Parents are also required to practice Child Centred Play exercises with the child every day, and are provided with a list of activities they can use at home.

Duration: The CCP treatment will be administered in conjuction with a Behavioural Family Intervention (BFI Program. The BFI program is conducted over six weekly 1.5 hour sessions. Each CCP session will take place directly after each BFI session. CCP sessions will take approximately 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 279935 0
Primary Outcome: Levels of disruptive behavior

Levels of disruptive behavior will be assessed in three ways:

1. DSM-IV-TR diagnostic status for Oppositional Defiant Disorder or Conduct Disorder as determined by the Diagnostic Interview Schedule for Children, Adolescents and Parents (DISCAP; Johnson, Barrett, Dadds, Fox, & Shortt, 1999).

2. Oppositional and conduct symptom severity, also assessed with the DISCAP.

3. Independent observations of disruptive behavior from video recordings of a ten minute free play procedure with parents and child. Videos will be coded using the FOS-VII coding schedule (Pasalich & Dadds, 2009). Videos will be coded for child non-compliance, criticisms, oppositionality, complaints and withdrawal. Both the consistency and intensity of variables are coded, along a 5-point scale ranging from 0 (no occurrence of the behaviour) to 4 (behaviour occurred a lot of the time and/or was of very high intensity).
Timepoint [1] 279935 0
1. Pre-treatment assessment

2. Immediate post treatment assessment (e.g., within a week of completing treatment)

3. Six month follow up assessment
Secondary outcome [1] 294804 0
Secondary Outcome: Changes in child eye gaze

Changes in child eye gaze will be assessed in two ways:

1. Independent observations of eye contact from video recordings of EE interactions. Videos will be coded using the FOS-VII coding schedule (Pasalich & Dadds, 2009). Videos will be coded for mother/father and child eye contact, initiated and rejected. Variables are coded along a 5-point scale ranging from 0 (no occurrence of the behaviour) to 4 (behaviour occurred a lot of the time).

2. Eye tracking data taken whilst participants perform a computer based emotion recognition task. Participants will be presented with facial stimuli expressing seven emotions (happiness, sadness, anger, disgust, fear, neutral, surprise), and asked to label each emotion. Eye gaze is tracked and recorded during the task. Data is analysed for frequency and duration of eye fixations, and number of first foci to the eyes.
Timepoint [1] 294804 0
1. Pre-treatment assessment

2. Immediate post treatment assessment (e.g., within a week of completing treatment)

3. Six month follow up assessment
Secondary outcome [2] 294805 0
Secondary Outcome: Changes in levels of relational warmth between parents and child

Changes in levels of relational warmth will be assessed in one way:

1. Independent observations of warmth from video recordings of EE interactions. Videos will be coded using the FOS-VII coding schedule (Pasalich & Dadds, 2009). Videos will be coded for mother/father and child level of comfort and genuineness during the interaction, as well as verbal and physical expressions of affection and positive affect. Both the consistency and intensity of variables are coded, along a 5-point scale ranging from 0 (no occurrence of the behavior) to 4 (behavior occurred a lot of the time and/or was of very high intensity).
Timepoint [2] 294805 0
1. Pre-treatment assessment

2. Immediate post treatment assessment (e.g., within a week of completing treatment)

3. Six month follow up assessment

Eligibility
Key inclusion criteria
Inclusion Criteria for children:

1. Primary DSM-IV-TR diagnosis of ODD or CD

2. Scores above the 80th percentile on the conduct problems scale of the Strength and Difficulties Questionnaire (SDQ; Goodman, 1997).

3. Callous-unemotional traits, as assessed by the UNSW system (Dadds, et al., 2005), which combines scores on the Antisocial Process Screening Device (ASPD; Frick & Hare, 2001) and the SDQ.

4. Fluency in English

Inclusion Criteria for Parent(s)/Caregivers:

1. Fluency in English
Minimum age
3 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for Children:

1. Current diagnosis of a psychotic disorder

2. Primary autism

3. Developmental delay (estimated at IQ < 80)

4. Major medical disorder that has significantly interfered with family or school life.

There are no exclusion criteria for parent(s)/caregivers.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284185 0
Government body
Name [1] 284185 0
National Health and Medical Research Council
Country [1] 284185 0
Australia
Primary sponsor type
Individual
Name
Professor Mark Dadds
Address
Room 802, Mathews Building
School of Psychology
University of New South Wales
Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 269141 0
Individual
Name [1] 269141 0
Therese English
Address [1] 269141 0
Level 14, Mathews Building
School of Psychology
University of New South Wales
Sydney, NSW 2052
Country [1] 269141 0
Australia
Other collaborator category [1] 260346 0
Individual
Name [1] 260346 0
Dr David Hawes
Address [1] 260346 0
Room 440, Brennan MacCallum Building
School of Psychology
The University of Sydney
NSW, 2006
Country [1] 260346 0
Australia
Other collaborator category [2] 260347 0
Individual
Name [2] 260347 0
Associate Professor John Brennan
Address [2] 260347 0
Sydney Children's Hospital
Mental Health Inpatient Unit
High Street
Randwick NSW 2031
Country [2] 260347 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286622 0
Ethics committee address [1] 286622 0
Ethics committee country [1] 286622 0
Date submitted for ethics approval [1] 286622 0
06/03/2012
Approval date [1] 286622 0
Ethics approval number [1] 286622 0

Summary
Brief summary
This study aims to evaluate the efficacy of a new treatment for disruptive children with callous-unemotional traits. The treatment is called 'Emotional Engagement' Treatment, and focuses on the affective dimension of parent-child relations. It has been created specifically to boost warmth in parent-child relationships, and remediate deficits in eye contact by enhancing the salience of the eyes for high CU children. The aims of the treatment are twofold – to increase parental warmth and to increase the child’s attention to parental warmth. It is believed that improvements in these areas will translate to reductions in disruptive and antisocial behavior. It is hypothesised that following treatment:

1. Children will show lower levels of disruptive behaviour
2. Children will show higher levels of eye contact
3. There will be higher levels of parental warmth
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33366 0
Address 33366 0
Country 33366 0
Phone 33366 0
Fax 33366 0
Email 33366 0
Contact person for public queries
Name 16613 0
Therese English
Address 16613 0
Level 14, Mathews Building
School of Psychology
University of New South Wales
Sydney, NSW, 2042
Country 16613 0
Australia
Phone 16613 0
+61 2 9385 2771
Fax 16613 0
Email 16613 0
[email protected]
Contact person for scientific queries
Name 7541 0
Professor Mark Dadds
Address 7541 0
Room 802, Mathews Building
School of Psychology
University of New South Wales
Sydney, 2052
Country 7541 0
Australia
Phone 7541 0
(61-2) 9385 3538
Fax 7541 0
(61-2) 9385 3641
Email 7541 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.