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Trial registered on ANZCTR


Registration number
ACTRN12615000756527
Ethics application status
Approved
Date submitted
17/05/2015
Date registered
21/07/2015
Date last updated
21/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Teacher and Parent Training (called 'Hitkashrut') for Young Children with Conduct Problems
Scientific title
Teacher and Parent Training for Young Children with Conduct Problems: A Randomized Controlled Trial of Effectiveness, Change Mechanism, Mediation, and Moderation
Secondary ID [1] 286725 0
Nil known
Universal Trial Number (UTN)
U1111-1170-2468
Trial acronym
Hitkashrut
Linked study record

Health condition
Health condition(s) or problem(s) studied:
early-onset conduct problems 295088 0
Condition category
Condition code
Mental Health 295338 295338 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed RCT of modular Teacher Training (TT) with/without Parent Training (PT) for early onset CP follows the development of Hitkashrut’s PT for preschoolers with CP and the completion of a 3-year RCT. Currently, Hitkashrut‘s PT is being disseminated, while a recently developed TT intervention has been implemented in 2013-4 by trained educational psychologists who are working in 6 cities that are already providing PT. Hitkashrut’s TT is a classwide program with an optional Individualized Positive Behavior Support component (IPBS). The modular design of TT and the option of a conjoining TTCI and PT enable the testing of interventions with increasing level of intensity. TT is our general term for teacher training. At minimum it is Teacher Training Classwide (TTC) and at maximum it is Teacher Training Classwide bolstered by the IPBS component (TTCI). The 4-group design includes the following conditions: 1. A no intervention Control group (CONT); 2. Teacher Training Classwide (TTC); 3. TTC bolstered by an IPBS component (TTCI); 4. TTCI with the addition of PT (TTCI+PT).
Interventions:
PT: PT groups of 5-7 couples (mother and father) meet for 14 two-hour weekly semi-structured sessions co-facilitated by two group leaders. The overall strategy focuses on reducing negative, coercive and inconsistent interactions while increasing security,regulation, and cooperation in parent-child, parent-teacher, and teacher-child relationships.
TT: Hitkashrut‘s model has been adapted to the kindergarten context. The 30-hour 10-session program incorporates established TT practices such as classroom management (e.g., the Good Behavior Game) that were culturally adapted, Teacher self-regulation, Discipline skills, etc. Altogether, the program reflects Hitkashrut’s strategic emphasis on strengthening secure, regulated, and cooperative relationships. For the TTC interventions, the teachers need to attend ten 3-hour training sessions. They begin to administer the intervention to students during the course of training. The additional component of TTCI intervention (IPBS) is administered when the teachers attend additional ten 3-hour training sessions. Again, they administer the intervention to students during the course of training.The IPBS is administered when the teachers create a contingency management intervention with an individual student. It is administered over a period of 2-3 month during which the teachers learn how to implement the intervention and are participating in the training.

Hitkashrut’s TT and PT incorporates at home/school behavioral management procedures that we term Individualized Positive Behavior Support (IPBS). IPBS targets both negative/inconsistent and positive parent/teacher practices.
(e.g., praise, tangible rewards, and differential reinforcement).

For groups that receive more than one intervention, the interventions are administered simultaneously.

Regarding strategies used to monitor adherence to the intervention, the facilitators monitor adherence during the training sessions by regularly opening each session with a report on the implementation of the interventions, followed by a discussion of specific problems or issues faced by the teachers. We also use program a program adherence questionnaire that is filled by teachers and facilitators at the end of training.

Intervention code [1] 291885 0
Prevention
Intervention code [2] 291886 0
Behaviour
Comparator / control treatment
The 4-group design has 72 children in each of the following conditions: 1. A no intervention Control group (CONT); 2. Teacher Training Classwide (TTC); 3. Teacher Training Classwide with IPBS (TTCI); 4. TTCI with the addition of PT (TTCI+PT).
Control group
Active

Outcomes
Primary outcome [1] 295088 0
Children's conduct problems assessed by Eyberg Behavior Inventory )(ECBI) and the SDQ, as assesed by parents and teachers. We will also test this outcome by a puppet interview: The Berkeley Puppet Interview (BPI).
Timepoint [1] 295088 0
Full assessments will be conducted before (T1), after the delivery of the 6-7 month interventions (T2), and at half-year follow-up (T3).
Secondary outcome [1] 314744 0
children’s dispositions (assesed by parent/teacher): Effortful control assessed by Child Behavioral Questionnaire (CBQ).
Timepoint [1] 314744 0
Full assessments will be conducted before (T1), after the delivery of the 6-7 month interventions (T2), and at half-year follow-up (T3).
Secondary outcome [2] 314745 0
Parental practices assessed by the Alabama Parenting Questionnaire – Preschool, Revised (assesed by parents)
Timepoint [2] 314745 0
Full assessments will be conducted before (T1), after the delivery of the 6-7 month interventions
(T2), and at half-year follow-up (T3).
Secondary outcome [3] 314746 0
Teacher-child relationship/practices assessed by The Teacher Strategies Questionnaire (teachers)
Timepoint [3] 314746 0
Full assessments will be conducted before (T1), after the delivery of the 6-7 month interventions
(T2), and at half-year follow-up (T3).
Secondary outcome [4] 314950 0
children’s dispositions (assesed by parent/teacher): Executive functions (EF) assessed by the Behavior Rating Inventory of Executive Function-Short Form (BRIEF);
Timepoint [4] 314950 0
Full assessments will be conducted before (T1), after the delivery of the 6-7 month interventions
(T2), and at half-year follow-up (T3).
Secondary outcome [5] 314951 0
children’s dispositions: Children’s “Hot” and “Cool” self-regulation assessed by a battery of laboratory developed tasks delivered to the child. More information on each of these tasks and their adaptation for field-based research is available: for Toy Wrap, Snack Delay, Pencil Tap, and Walk-a-Line Slowly (Denham, Warren- Khot, Bassett, Wyatt, & Perna, 2012; Smith-Donald, Raver, Hayes, & Richardson, 2007), for Silly Sounds Stroop, (Willoughby, Wirth, & Blair, 2012), and for Head-Toes-Knees-Shoulders (Ponitz, McClelland, Matthews, & Morrison, 2009)
Timepoint [5] 314951 0
Full assessments will be conducted before (T1), after the delivery of the 6-7 month interventions
(T2), and at half-year follow-up (T3).
Secondary outcome [6] 314952 0
children’s dispositions (assesed by parent/teacher): Callous/Unemotional traits assessed by the ICU.
Timepoint [6] 314952 0
Full assessments will be conducted before (T1), after the delivery of the 6-7 month interventions
(T2), and at half-year follow-up (T3).

Eligibility
Key inclusion criteria
Inclusion criteria: (a) age 4-6; (b) disruptive behaviors in the subclinical-clinical range using SDQ- Teacher’s local norms (Elizur, Ben-Simon, & Hirsh Bar-Asher, 2009); (c) no physical disability, intellectual impairment, or pervasive developmental delay reported by teachers; (d) no other psychological treatment; (e) parental signed consent and commitment of both parents to participate in PT and to randomized treatment allocation.
Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
physical disability, intellectual impairment, or pervasive developmental delay reported by teachers; other psychological treatment;

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will use a random numbers generator to first assign teachers who intend to enroll in Hitkashrut‘s TT to either TT or another course provided in their local Pisgah, and then assign the parents to intervention and control groups. Allocation will be concealed by numbered containers. The candidate parents and teachers will be informed about the interventions and randomization procedure. Parents and teachers who consent and commit to PT and TT respectively, either in the current year if allocated or to next year’s training, will join the study. They will be informed that delivery of next year’s PT and TT is conditional since the programs are publically funded, but past experience indicates that training groups have been regularly opened once they were established in a particular location. There would be 6 intervention and 6 control kindergartens in each city. Using this randomization procedure, 3 children from each intervention kindergarten will be assigned to each of the 3 intervention groups, while one of 3 selected children in each control kindergarten will be assigned to CONT. This procedure fulfills ethical standards while ensuring similar level of parental motivation in different groups, thus controlling for selection bias. The groups will be compared on relevant characteristics to ensure that they do not differ significantly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Recruiting
Date of first participant enrolment
Anticipated
1/11/2014
Actual
7/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
288
Accrual to date
Final
Recruitment outside Australia
Country [1] 6884 0
Israel
State/province [1] 6884 0

Funding & Sponsors
Funding source category [1] 291284 0
Government body
Name [1] 291284 0
Israel science foundation
Country [1] 291284 0
Israel
Primary sponsor type
Individual
Name
Prof. Yoel Elizur
Address
The Hebrew University of Jerusalem, Mount Scopus, Jerusalem 91905
Country
Israel
Secondary sponsor category [1] 289959 0
Individual
Name [1] 289959 0
Lior Y, Somech
Address [1] 289959 0
The Hebrew University of Jerusalem, Mount Scopus, Jerusalem 91905
Country [1] 289959 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292850 0
Chief Scientist of the Ministry of Education
Ethics committee address [1] 292850 0
Deborah Haneviah 2, Jerusalem 91911
Ethics committee country [1] 292850 0
Israel
Date submitted for ethics approval [1] 292850 0
Approval date [1] 292850 0
02/09/2014
Ethics approval number [1] 292850 0

Summary
Brief summary
Advancement in developing best practices for preschool conduct problems and in the dissemination of these practices into service delivery systems is essential given the prevalence, continuity, and long-term effects of early onset conduct problems (CP). Randomized controlled trials (RCTs) in real world settings enable the testing of effectiveness, mechanisms of change, and outcome mediators and moderators, all of which contribute to scientific understanding, practice, and policy. Comparative RCTs of modular programs can be particularly informative and advance the development of effective and disseminable interventions.
The proposed RCT of modular Teacher Training (TT) with/without Parent Training (PT) for early onset CP follows the development of Hitkashrut’s PT for preschoolers with CP and the completion of a 3-year RCT. Hitkashrut’s TT is a classwide program with an optional Individualized Positive Behavior Support component (IPBS). The modular design of TT and the option of a conjoining TTCI and PT enable the testing of interventions with increasing level of intensity.
Our objectives are: 1. Testing the effectiveness of each intervention vs. CONT; 2. Testing the comparative effectiveness TTCI+PT vs. TTC, TTCI vs. TTC, and TTCI+PT vs. TTCI; 3. Testing outcome mediators at the relationship and child level; 4. Testing IPBS as a mechanism of change in both parent and teacher groups during the course of TTCI+PT and TTCI; 5. Testing moderators to determine for whom or under what conditions treatment is effective; 6. Analyzing antisocial developmental trajectories with respect to both children’s and relationship variables.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57322 0
Prof Yoel Elizur
Address 57322 0
Hebrew University of Jerusalem, Mount Scopus, Jerusalem, Israel 91905
Country 57322 0
Israel
Phone 57322 0
972-2-588-1331
Fax 57322 0
Email 57322 0
[email protected]
Contact person for public queries
Name 57323 0
Dr Lior Y, Somech
Address 57323 0
Hebrew University of Jerusalem, Mount Scopus, Jerusalem, Israel 91905
Country 57323 0
Israel
Phone 57323 0
972-2-588-1331
Fax 57323 0
Email 57323 0
[email protected]
Contact person for scientific queries
Name 57324 0
Prof Yoel Elizur
Address 57324 0
Hebrew University of Jerusalem, Mount Scopus, Jerusalem, Israel 91905
Country 57324 0
Israel
Phone 57324 0
972-2-588-1331
Fax 57324 0
Email 57324 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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