Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT03905278 - Parental Support Intervention in the Oncological Context N/A
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04101799 - Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden N/A
Completed NCT01432756 - A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents N/A
Recruiting NCT05706376 - An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention N/A
Completed NCT05930535 - Family-Focused Adolescent & Lifelong Health Promotion N/A
Completed NCT03658122 - Integrating Behavioral Treatment in Primary Care N/A
Recruiting NCT06099262 - GenPMTO Evaluation
Recruiting NCT04853888 - ATTACHâ„¢ Program: Promoting Vulnerable Children's Health at Scale N/A
Completed NCT04633434 - Evaluation Study of Talk Parenting Skills N/A
Recruiting NCT04627415 - Project PEAK: Early Intervention for ADHD N/A
Completed NCT04257331 - Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China N/A
Withdrawn NCT05135507 - The Effective Parenting Program (EPP) N/A
Completed NCT03853564 - Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities N/A
Active, not recruiting NCT05264415 - Intergenerational Transmission of Traumatic Stress N/A
Completed NCT04342871 - An Evaluation of the Fathers and Mothers With Cancer Communication Tool N/A
Recruiting NCT04107506 - The Supporting Early Learning Study N/A
Recruiting NCT04827225 - Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child