NCT01955551

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

September 28, 2013

Last Update Submit

December 1, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Participant intention to attend IYS sessions

    1 week

Secondary Outcomes (3)

  • Attendance at initial IYS session

    1 month

  • Number of IYS sessions attended

    9 months

  • Satisfaction with the IYS program, as measured by a 46-item IYS questionnaire

    9 months

Study Arms (2)

Motiv. Interviewing

EXPERIMENTAL

In the MI (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.

Behavioral: Motivational Interviewing

Anticipatory Guidance

ACTIVE COMPARATOR

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.

Behavioral: Anticipatory Guidance on Child Development

Interventions

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.

Motiv. Interviewing

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.

Anticipatory Guidance

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • child is a foster child
  • parent or child cannot communicate in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109-5406, United States

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Julie C Lumeng

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

September 28, 2013

First Posted

October 7, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations