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Trial registered on ANZCTR


Registration number
ACTRN12612000148875
Ethics application status
Approved
Date submitted
31/01/2012
Date registered
2/02/2012
Date last updated
3/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting Self-Regulation and Cooperation in Pre-Kindergarten children with Conduct
Problems: A Randomized Controlled Trial
Scientific title
The effect of a "common elements" co-parent training program (called 'Hitkashrut') on conduct in preschoolers at risk for conduct problems.
Secondary ID [1] 279827 0
Nil
Universal Trial Number (UTN)
U1111-1127-5296
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
conduct problems 285711 0
Condition category
Condition code
Mental Health 285893 285893 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (called `Hitkashrut`):
In October 2006 a research pilot was initiated with kindergarten teachers in order to create Israeli norms for a screening instrument and to test screening and referral procedures in collaboration with national supervisors of Ministry of Education`s Preschool education division. Master-level educational psychologists working at three local services in the Jerusalem region co-facilitated a manual-based sequence of semi-structured two-hour meetings with groups of 5-7 couples. Sessions were conducted once weekly over a period of 14 weeks and were organized according to a 4-part structure: joining and following-up on last session’s homework; psycho-educational instruction with facilitators’ modeling problematic and optimal behaviors using prepared role plays; group discussion including spontaneous parental role plays; summary of take-home points and home-work assignments. Handouts summarized each session and highlighted the take-home points. Behavior management skills were learned and practiced by establishing differential reinforcement programs with each parental dyad during a half-hour couple meeting with one facilitator (after session 5 only), followed by one phone call and in-session checkups.
Intervention code [1] 284144 0
Prevention
Intervention code [2] 284145 0
Behaviour
Comparator / control treatment
Minimal Support Control Group. The parents were referred for two consultation sessions (2 hours). Sessions occurred at baseline and 3 months later, and were administered by Master-level educational psychologists to each couple. The facilitators made use of Hitkashrut’s key components and handouts, and where necessary referred parents to regular community care.
Control group
Active

Outcomes
Primary outcome [1] 286388 0
Primary Outcome: Children`s Conduct Problems as assessed by Eyberg Child Behavior Inventory (ECBI).
Timepoint [1] 286388 0
T1: pre-intervention (Baseline); T2: within one month post- intervention; T3: 1-year follow-up.
Secondary outcome [1] 295750 0
Callous-unemotional traits as assessed by the preschool modification of the Antisocial Process Screening Device and a preschool version of the Inventory of CU traits.
Timepoint [1] 295750 0
T1: pre-intervention (Baseline); T2: within one month post- intervention; T3 (only intervention group) 1-year follow-up.
Secondary outcome [2] 295751 0
Effortful Control as assessed by the Child Behavioral Questionnaire (CBQ) adapted for preschoolers
Timepoint [2] 295751 0
T1: pre-intervention (Baseline); T2: within one month post- intervention; T3 (only intervention group) 1-year follow-up.
Secondary outcome [3] 295752 0
parental distress as assessed by the Parental Stress Index-Short Form (PSI-SF), and the Parental Helplessness Questionnaire.
Timepoint [3] 295752 0
T1: pre-intervention (Baseline); T2: within one month post- intervention.
Secondary outcome [4] 295753 0
Negative/inconsistent parenting as assessed by the Alabama Parenting Questionnaire- Preschool, Revised.
Timepoint [4] 295753 0
T1: pre-intervention (Baseline); T2: within one month post- intervention.
Secondary outcome [5] 295754 0
Couple relationship quality as assessed by the Marital Quality Scale (MQS-I).
Timepoint [5] 295754 0
T1: pre-intervention (Baseline); T2: within one month post- intervention.

Eligibility
Key inclusion criteria
Inclusion criteria were (a) enrolment in pre-kindergartens (in Israel usually 3-5 years old); (b) significant disruptive behaviors; (c) no physical disability, intellectual impairment, or pervasive developmental delay reported by teachers; (d) no other psychological treatment; (e) agreement of both caregivers to attend.
Minimum age
32 Months
Maximum age
64 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were (a) physical disability, intellectual impairment, or pervasive developmental delay reported by teachers; (b) other psychological treatment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number sequences were generated using a randomisation table from a statistic book (The 2:1 allocation using random numbers).
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
Completed
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 outside Australia
Country [1] 4093 0
Israel
State/province [1] 4093 0

Funding & Sponsors
Funding source category [1] 284602 0
Government body
Name [1] 284602 0
Ministry of Education
Address [1] 284602 0
Deborah haneviha 2, Jerusalem 91911
Country [1] 284602 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] 283521 0
Individual
Name [1] 283521 0
Lior Y. Somech
Address [1] 283521 0
The Hebrew University of Jerusalem, Mount Scopus, Jerusalem 91905
Country [1] 283521 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286597 0
Chief Scientist of the Ministry of Education
Ethics committee address [1] 286597 0
Deborah Haneviah 2, Jerusalem 91911
Ethics committee country [1] 286597 0
Israel
Date submitted for ethics approval [1] 286597 0
Approval date [1] 286597 0
29/11/2007
Ethics approval number [1] 286597 0

Summary
Brief summary
The objective of the study was to test the real-world effectiveness and mechanisms of Hitkashrut: a theory-based, “common elements”, PT program for early intervention with preschoolers (3-5) at risk for conduct problems. Hitkashrut, "attachment" in Hebrew, is also an acronym for relationship- supporting and hope-inspiring parenting. Hitkashrut’s intervention model was based on the theory and research of disruptive developmental pathways that showed elevated levels of child malleability and caretakers' influence during the preschool years and consequently, unique opportunities for changing the CP trajectory by restructuring formative parental/marital patterns. Hitkashrut’s overall strategy for changing child CP and associated dispositions is to inhibit negative and oftentimes coercive parent-child cycles and to promote regulated cooperative relationships characterized by mutual responsiveness and positive affectivity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33701 0
Address 33701 0
Country 33701 0
Phone 33701 0
Fax 33701 0
Email 33701 0
Contact person for public queries
Name 16948 0
Lior Y. Somech
Address 16948 0
Hebrew University of Jerusalem
Mount Scopus, Jerusalem, Israel 91905
Country 16948 0
Israel
Phone 16948 0
972-2-588-1331
Fax 16948 0
Email 16948 0
somech.lior@gmail.com
Contact person for scientific queries
Name 7876 0
Prof. Yoel Elizur
Address 7876 0
Hebrew University of Jerusalem
Mount Scopus, Jerusalem, Israel 91905
Country 7876 0
Israel
Phone 7876 0
972-2-588-1331
Fax 7876 0
Email 7876 0
mselizur@mscc.huji.ac.il

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary