Behavior ProblemsPhase 2NCT01955551
Motivational Interviewing to Increase Parent Engagement in Preventive Parenting Programming
A Phase 2 study testing Motivational Interviewing and Anticipatory Guidance on Child Development in people with Behavior Problems and Parent-Child Relations, run by University of Michigan at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Behavior Problems, Parent-Child Relations
- What is being tested?
- Motivational Interviewing and Anticipatory Guidance on Child Development
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all children enrolled in the Head Start agencies involved in this study, who were randomized to the study arm involving the Incredible Years Series
Who cannot join
- child is a foster child
- parent or child cannot communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-5406
About this study
Official title: A Randomized Controlled Trial Evaluating the Use of Motivational Interviewing to Increase Engagement by Low-income Parents in Preventive Parenting-skills Programming
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.
Read more
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).
- Conditions
- Behavior Problems, Parent-Child Relations
- Being tested
- Motivational Interviewing, Anticipatory Guidance on Child Development
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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 DevelopmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Anticipatory Guidance on Child Development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant intention to attend IYS sessions
Measured: 1 week
Secondary outcomes (3)
Attendance at initial IYS session
Measured: 1 month
Number of IYS sessions attended
Measured: 9 months
Satisfaction with the IYS program, as measured by a 46-item IYS questionnaire
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior ProblemsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lumeng, University of Michigan
- Investigators
- Julie C Lumeng, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955551
- Sponsor's protocol ID
- SDBP_Research_Grant_2013
- Status last verified
- Dec 2015
- First submitted
- 28 Sep 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Use of Motivational Interviewing to Increase Engagement by Low-income Parents in Preventive Parenting-skills Programming
- ClinicalTrials.gov ID
- NCT01955551
- Acronym / sponsor ID
- SDBP_Research_Grant_2013
- Conditions
- Behavior Problems, Parent-Child Relations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motiv. Interviewing | Experimental | Behavioral: Motivational InterviewingIn 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. |
| Anticipatory Guidance | Active comparator | Behavioral: Anticipatory Guidance on Child DevelopmentIn 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all children enrolled in the Head Start agencies involved in this study, who were randomized to the study arm involving the Incredible Years Series
Key exclusion criteria (2 listed)
- child is a foster child
- parent or child cannot communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingIn 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. | Behavioural | Motiv. Interviewing |
| Anticipatory Guidance on Child DevelopmentIn 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. | Behavioural | Anticipatory Guidance |
Primary outcome
Participant intention to attend IYS sessions
Time frame: 1 week
3 secondary outcomes
Attendance at initial IYS session
Time frame: 1 month
Number of IYS sessions attended
Time frame: 9 months
Satisfaction with the IYS program, as measured by a 46-item IYS questionnaire
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie C Lumeng principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motivational Interviewing and Anticipatory Guidance on Child Development in people with Behavior Problems and Parent-Child Relations, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant intention to attend IYS sessions (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.