Parenting, Child Behavior, ImplementationNCT02709291
Systematically Adapted Delivery of the Family Check-Up
A study testing behavioral parent training and interventionist training in people with Parenting, Child Behavior, Implementation, run by Christina Studts at 1 site in United States.
Trial summary
Early childhood disruptive behavior problems lead to significant costs to families and society, but can be reduced with behavioral parent training interventions. To increase the public health impact of these interventions, their feasibility, accessibility, and acceptability in high-need, underserved communities must… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Parenting, Child Behavior, Implementation
- What is being tested?
- behavioral parent training and interventionist training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 26 Jun 2018
- Phase
- Interventional
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents: aged 18+ years, custodial guardian of child, can speak/read/understand English
- Children: ages 3-5 years, lives full time in custodial guardian's home
- Community health workers: aged 18+ years, currently employed at a partnering health department, able to speak/read/understand English
Who cannot join
- Parents: has already accessed behavioral health services for the child, reports suicidal ideation or intent to harm self or others, participated in formative research for this study
- Children: diagnosed with a severe developmental condition (i.e., significant developmental delay, autism, debilitating neurological condition)
- Community health workers: none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systematically Adapted Delivery of the Family Check-Up in Underserved Communities
Early childhood disruptive behavior problems lead to significant costs to families and society, but can be reduced with behavioral parent training interventions. To increase the public health impact of these interventions, their feasibility, accessibility, and acceptability in high-need, underserved communities must be ensured. This pilot project will systematically adapt and pilot-test the delivery model of an existing effective parent training intervention for implementation in rural Appalachia, a region with many documented health disparities, high levels of poverty, and shortages of mental health providers. Community health workers in 5 rural Appalachian counties will be trained to deliver a behavioral parent training intervention. Each worker will deliver the intervention to 4 parent-child dyads.
- Being tested
- behavioral parent training, interventionist training
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral parent trainingBehavioural
Parents receive up to 6 sessions of the Family Check-Up program
interventionist trainingBehavioural
Interventionists are trained in the delivery of the Family Check-Up program and deliver sessions to families in their community
| Study group | Role | What they receive |
|---|---|---|
| Community Health Workers | Other | Community health workers will complete a 5-day interventionist training to deliver a behavioral parent training intervention. Receives: Behavioral: interventionist training |
| Parent-Child Dyads | Other | Parents and children will receive a behavioral parent training intervention delivered by community health workers. Receives: Behavioral: behavioral parent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Enrollment
Percentage of invited parents who enroll in the study (obtained from process records)
Measured: 2 weeks after final parent-child dyad completes the study
Secondary outcomes (6)
Feasibility: Number of sessions completed
Number of sessions completed by each parent-child dyad (obtained from process records)
Measured: 2 weeks after final parent-child dyad completes the study
Feasibility: Interventionist-reported fidelity
Fidelity Checklist (completed by community health workers)
Measured: following each behavioral parent training intervention session
Feasibility: Parent satisfaction
European Parent Satisfaction Scale about Early Intervention (EPASSEI) (completed by parents)
Measured: 10 weeks after parent baseline
Interventionist satisfaction
Therapist Satisfaction Index (completed by community health workers)
Measured: 2 weeks after final parent-child dyad completes study
Interventionist evidence-based practice attitudes
Evidence-Based Practice Attitude Scale-50 (completed by community health workers)
Measured: 2 weeks after final parent-child dyad completes study
Interventionist self-efficacy
Counselor Activity Self-Efficacy Scale (completed by community health workers)
Measured: 2 weeks after final parent-child dyad completes study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study start20 Feb 2017
- Primary completion16 May 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenting, Child Behavior, ImplementationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christina Studts
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Christina Studts, University of Kentucky
- Investigators
- Christina R Studts, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709291
- Sponsor's protocol ID
- R34MH106661
- Other IDs
- R34MH106661
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2016
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematically Adapted Delivery of the Family Check-Up in Underserved Communities
- ClinicalTrials.gov ID
- NCT02709291
- Acronym / sponsor ID
- R34MH106661
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Christina StudtsUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 16 Mar 2016 (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.
Early childhood disruptive behavior problems lead to significant costs to families and society, but can be reduced with behavioral parent training interventions. To increase the public health impact of these interventions, their feasibility, accessibility, and acceptability in high-need, underserved communities must be ensured. This pilot project will systematically adapt and pilot-test the delivery model of an existing effective parent training intervention for implementation in rural Appalachia, a region with many documented health disparities, high levels of poverty, and shortages of mental health providers. Community health workers in 5 rural Appalachian counties will be trained to deliver a behavioral parent training intervention. Each worker will deliver the intervention to 4 parent-child dyads.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Workers | Other | Behavioral: interventionist trainingCommunity health workers will complete a 5-day interventionist training to deliver a behavioral parent training intervention. |
| Parent-Child Dyads | Other | Behavioral: behavioral parent trainingParents and children will receive a behavioral parent training intervention delivered by community health workers. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parents: aged 18+ years, custodial guardian of child, can speak/read/understand English
- Children: ages 3-5 years, lives full time in custodial guardian's home
- Community health workers: aged 18+ years, currently employed at a partnering health department, able to speak/read/understand English
Key exclusion criteria (3 listed)
- Parents: has already accessed behavioral health services for the child, reports suicidal ideation or intent to harm self or others, participated in formative research for this study
- Children: diagnosed with a severe developmental condition (i.e., significant developmental delay, autism, debilitating neurological condition)
- Community health workers: none
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 |
|---|---|---|
| behavioral parent trainingParents receive up to 6 sessions of the Family Check-Up program | Behavioural | Parent-Child Dyads |
| interventionist trainingInterventionists are trained in the delivery of the Family Check-Up program and deliver sessions to families in their community | Behavioural | Community Health Workers |
Primary outcome
Feasibility: Enrollment
Time frame: 2 weeks after final parent-child dyad completes the study
Percentage of invited parents who enroll in the study (obtained from process records)
6 secondary outcomes
Feasibility: Number of sessions completed
Time frame: 2 weeks after final parent-child dyad completes the study
Feasibility: Interventionist-reported fidelity
Time frame: following each behavioral parent training intervention session
Feasibility: Parent satisfaction
Time frame: 10 weeks after parent baseline
Interventionist satisfaction
Time frame: 2 weeks after final parent-child dyad completes study
Interventionist evidence-based practice attitudes
Time frame: 2 weeks after final parent-child dyad completes study
Interventionist self-efficacy
Time frame: 2 weeks after final parent-child dyad completes study
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 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Christina R Studts, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral parent training and interventionist training in people with Parenting, Child Behavior, Implementation, run by Christina Studts 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 3 inclusion and 3 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 Apr 2019. 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.
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?
Feasibility: Enrollment (time frame: 2 weeks after final parent-child dyad completes the study). 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 Apr 2019.