FathersNCT01395238
Enhancing Father's Ability to Support Their Preschool Child
A study testing Fathers Supporting Success in preschoolers in people with Fathers and Parenting, run by Queens College, The City University of New York at 1 site in United States.
Trial summary
This study focuses on the development of the Fathers Supporting Success in Preschoolers (FSSP) Program, which combines evidence-based parenting interventions with Dialogic Reading to engage fathers in and improve parenting and child behavior. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- Fathers Supporting Success in preschoolers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2012
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male Guardian
- Child enrolled in partnering Head Start site
Who cannot join
- Mental Health issues that prohibit involvement in group-based prevention study (e.g., psychosis)
Trial locations and contacts
1 site in 1 country.
About this study
This study focuses on the development of the Fathers Supporting Success in Preschoolers (FSSP) Program, which combines evidence-based parenting interventions with Dialogic Reading to engage fathers in and improve parenting and child behavior.
- Conditions
- Fathers, Parenting, High-risk, Child Maltreatment, Prevention
- Being tested
- Fathers Supporting Success in preschoolers
- Keywords
- fathers, parenting, high-risk, child maltreatment, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fathers Supporting Success in preschoolersBehavioural
Group-based, 8 weekly session for 2.0 hours/week.
| Study group | Role | What they receive |
|---|---|---|
| Wait-List Group | No intervention | Not described |
| Parenting Group | Experimental | Experimental Condition. Group-based, 8 weekly sessions/2 hours per week. Receives: Behavioral: Fathers Supporting Success in preschoolers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Behavior Checklist
Reporting change in parenting behavior from baseline to immediately after intervention
Measured: post treatment (8 weeks after start of treatment )
Eyberg Child Behavior Inventory
Reporting change in child behavior from baseline to immediately after intervention
Measured: post treatment (8 weeks after start of treatment )
Secondary outcomes (4)
Center for Epidemiological Studies Depression Scale
Reporting change in paternal depression from baseline to immediately after intervention
Measured: post treatment (8 weeks after start of treatment )
Parent Cognition Scale
Measurement of parents cognitions regarding children behavior. reporting change in parental cognitions from baseline to immediatley after intervention
Measured: post treatment (8 weeks after start of treatment )
Preschool Language Scales
Assessment of child langauge skills. reporting changes in children's language from baseline to immediatley after intervention
Measured: post treatment (8 weeks after start of treatment )
Developing Skills Checklist
Assessment of early literacy skills. Reporting changes in children's literacy skills from baseline to immediately after treatment
Measured: post treatment (8 weeks after start of treatment )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Grant ended and faculty has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FathersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queens College, The City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York at Buffalo
- Responsible party
- Principal investigator, Poline Papoulis, Queens College, The City University of New York
- Investigators
- Anil Chacko, PhD, Principal investigator, Queens College, CUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395238
- Sponsor's protocol ID
- 1U01CE001653
- Status last verified
- Mar 2019
- First submitted
- 23 May 2011
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Father's Ability to Support Their Preschool Child
- ClinicalTrials.gov ID
- NCT01395238
- Acronym / sponsor ID
- 1U01CE001653
- Conditions
- Fathers, Parenting, High-risk, Child Maltreatment, Prevention
- Keywords
- fathers, parenting, high-risk, child maltreatment, prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant ended and faculty has left the institution
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Queens College, The City University of New YorkUniversity, hospital or other
- Collaborators
- State University of New York at Buffalo
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Jul 2011 (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.
This study focuses on the development of the Fathers Supporting Success in Preschoolers (FSSP) Program, which combines evidence-based parenting interventions with Dialogic Reading to engage fathers in and improve parenting and child behavior.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-List Group | No intervention | – |
| Parenting Group | Experimental | Behavioral: Fathers Supporting Success in preschoolersExperimental Condition. Group-based, 8 weekly sessions/2 hours per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male Guardian
- Child enrolled in partnering Head Start site
Key exclusion criteria (1 listed)
- Mental Health issues that prohibit involvement in group-based prevention study (e.g., psychosis)
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 |
|---|---|---|
| Fathers Supporting Success in preschoolersGroup-based, 8 weekly session for 2.0 hours/week. | Behavioural | Parenting Group |
Primary outcome
Parenting Behavior Checklist
Time frame: post treatment (8 weeks after start of treatment )
Reporting change in parenting behavior from baseline to immediately after intervention
Eyberg Child Behavior Inventory
Time frame: post treatment (8 weeks after start of treatment )
Reporting change in child behavior from baseline to immediately after intervention
4 secondary outcomes
Center for Epidemiological Studies Depression Scale
Time frame: post treatment (8 weeks after start of treatment )
Parent Cognition Scale
Time frame: post treatment (8 weeks after start of treatment )
Preschool Language Scales
Time frame: post treatment (8 weeks after start of treatment )
Developing Skills Checklist
Time frame: post treatment (8 weeks after start of treatment )
Results and safety
The study was stopped early (reason given: Grant ended and faculty has left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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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.
Anil Chacko, PhD principal investigator
Queens College, CUNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fathers Supporting Success in preschoolers in people with Fathers and Parenting, run by Queens College, The City University of New York 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Mar 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 was stopped early (reason given: Grant ended and faculty has left the institution). Results are not available in the source record.
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?
Parenting Behavior Checklist (time frame: post treatment (8 weeks after start of treatment )). The study lists 2 primary outcomes in all. 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 27 Mar 2019.