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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02850510
Other study ID # Shortened version Basic IY
Secondary ID
Status Completed
Phase N/A
First received July 20, 2016
Last updated July 29, 2016
Start date January 2004
Est. completion date June 2016

Study information

Verified date July 2016
Source Regional centre for children and youth mental health and welfare
Contact n/a
Is FDA regulated No
Health authority Norway: Directorate of Health
Study type Interventional

Clinical Trial Summary

Aim of study:

To evaluate the effects of the shortened version of the Incredible Years (IY) Basic programme, the study which the parents were recruited to. A randomising experimental control between-group design was used with pre- and post-intervention measurements, and a one-year, four-year and ten-year follow-up. Children and families were randomized to either the shortened basic version (n = 89), or the control group (n = 97).


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 8 Years
Eligibility Inclusion Criteria:

- No diagnosable behavior problems in child

Exclusion Criteria:

- Diagnosable behavior problems in child

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Brief Incredible Years parent training
The IY parent training programme (3-8 years) developed by Webster-Stratton at the Parenting Clinic, University of Washington, is a manualised and video-based training programme for parents of young children with conduct problems (Webster-Stratton and Reid, 2003a). Parents assigned to the short IY Basic (S-IY) condition were divided into groups of 10-12 parents. The S-IY was led by two experienced group leaders and parents met weekly for two-hour sessions at a public health care center in the community. The group leaders led discussions regarding central aspects of parenting on the basis of the video vignettes, role play and homework.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Regional centre for children and youth mental health and welfare

Outcome

Type Measure Description Time frame Safety issue
Primary Longitudinal change in ECBI scores Eyberg Child Behavior Inventory (Robinson et al., 1980). The ECBI provides a list of 36 problem behaviours commonly reported by parents of children with disruptive behaviour problems. The inventory assesses behaviour on two dimensions: the frequency of the behaviour and its identification as a problem. The frequency ratings range from 1 (never) to 7 (always), and are summed to yield an overall problem behaviour Intensity score (Cronbach's alpha 1/4 0.82) ranging from 36 to 252. baseline, 6-8 weeks after intervention, one-year follow up, four-year follow up, ten-year follow up No
Secondary Reasons for participation and help seeking behaviour A questionnaire consisting of 12 questions was developed to assess parents' reasons for participating in child rearing classes. Three subscales measure parental concern (five items, a 1/4 0.82), motivation to learn (three items, a 1/4 0.42), and own/other's opinion (three items, a 1/4 0.42). The questionnaire was sent to all participants in the study. Examples of the questions were: ''I was concerned for my child's behaviour'', ''I was uncertain of how to raise my child'', and ''I think it's interesting to learn about children''. All questions were answered using a five-point Likert scale from ''agree'' to ''disagree''. Four-year follow up No
Secondary Longitudinal change in PROC scores Parents Sense of Competence (Johnston and Mash, 1989). The PSOC consists of 16 items about parents' confidence on being a parent, answered on a six-point scale ranging from ''strongly disagree'' to ''strongly agree''. Scoring for some items is reversed so that, for all items, higher scores indicate greater parenting self-esteem. Two subscales measure efficacy (seven items, a 1/4 0.69) and satisfaction (nine items, a 1/4 0.77) in parenting. baseline, 6-8 weeks after intervention, one-year follow up, four-year follow up, ten-year follow up No
Secondary Longitudinal change in PSI scores Parent Stress Index, Short Form (PSI-SF; Abidin, 1995). The PSI-SF is a 36 item self-report measure of parenting stress, derived from the full version PSI. The PSI-SF yields a total stress (a 1/4 0.90) in addition to scores on three scales: parental distress, parent-child dysfunctional interaction, and difficult child. baseline, 6-8 weeks after intervention, one-year follow up, four-year follow up, ten-year follow up No
Secondary Longitudinal change in PPI scores Parenting Practices Interview (Webster-Stratton et al., 2001). The PPI was adapted from the Oregon Social Learning Centre's Discipline Questionnaire. Two subscales were used; Harsh Discipline (14 items, a 1/4 0.79), and Positive Parenting (15 items, a 1/4 0.67). Parents reported the probability and the frequency with which they used the different strategies on a seven-point scale. baseline, 6-8 weeks after intervention, one-year follow up, four-year follow up, ten-year follow up No
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