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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01955551
Other study ID # SDBP_Research_Grant_2013
Secondary ID
Status Completed
Phase Phase 2
First received September 28, 2013
Last updated December 1, 2015
Start date September 2013
Est. completion date June 2015

Study information

Verified date December 2015
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Evidence-based programs aimed at enhancing parenting skills are effective, and pediatricians identify many parents who could benefit from such programs. Low-income children have high rates of behavior problems and their family system and environmental exposures often lead to cumulative and daunting levels of risk for poor functional outcomes; their parents are highly likely to benefit from parenting supports. However, low-income families are the most likely to drop out of parenting interventions, meaning the families and children with the greatest need receive the least support. Fewer than 25% of low-income families recruited to parenting programs will participate in even one session, and only about half of these parents will participate in more than half of the sessions offered. The aims of this trial are:

Aim 1: To test the hypothesis that the provision of motivational interviewing (MI), as compared to an attention control (AC) condition, will increase the engagement of low-income parents of preschoolers in an evidence-based parenting skills group (the Incredible Years Series (IYS)). For this study, the outcome of engagement is operationally defined as intention to attend IYS sessions, attendance, and satisfaction with the IYS program.

Aim 2: To test the hypothesis that the effect of MI on engagement in IYS will be impacted by the following moderators: parenting self-efficacy, child behavior problems, and maternal depression.

The investigators hypothesize that the effect of MI on engagement will be greater among parents with lower parenting self-efficacy and parents of children with more behavior problems, but less among parents with more maternal depressive symptoms.

The investigators will use a stratified, randomized controlled trial (RCT) design to evaluate the impact of MI on parent engagement in a well-validated preventive parenting skills intervention, the Incredible Years Series (IYS).


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Years and older
Eligibility Inclusion Criteria:

- all children enrolled in the Head Start agencies involved in this study, who were randomized to the study arm involving the Incredible Years Series

Exclusion Criteria:

- child is a foster child

- parent or child cannot communicate in English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing
In the Motivational Interviewing study arm, participants will receive MI phone calls designed to evoke change talk and to prompt the participant to identify goals in regards to child behavior or parenting. The caller will engage in problem solving with the participants.
Anticipatory Guidance on Child Development
In the Anticipatory Guidance on Child Development study arm, the participants will receive two phone calls with no MI content. The content of these phone calls is derived from an alignment of the Teaching Strategies GOLD® standards with the Head Start Development and Early Learning Framework. , This content is entirely scripted and pre-specified.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participant intention to attend IYS sessions 1 week No
Secondary Attendance at initial IYS session 1 month No
Secondary Number of IYS sessions attended 9 months No
Secondary Satisfaction with the IYS program, as measured by a 46-item IYS questionnaire 9 months No
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