Adolescent, ParentingNCT03921892
A Comparison of Parenting Education Approaches for Adolescent Fathers
A study testing Parenting Education in people with Adolescent, Parenting, run by University of Missouri, Kansas City at 3 sites in United States.
Trial summary
This feasibility and acceptability study will compare in-person to web-based parenting education for adolescent fathers on the outcomes of parenting confidence and participation in parenting activities. Read more about this study
- Who is it for?
- Ages 15 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent, Parenting
- What is being tested?
- Parenting Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2019to 15 Sep 2020
- 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 15 to 21 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 15 to 21,
- be able to read and understand English (as determined by having the individual read a brief, eighth grade reading level paragraph),
- able to begin the intervention within six weeks of their infant's birth,
- be able to participate in an intervention over two weeks, requiring approximately a 12-hour time commitment: either in-person on two Saturdays for six hours each, or a self-paced content of videos and resource materials over two weeks,
- own or have access to a device with internet access and
- have a working e-mail address.
Who cannot join
- Any condition that might prevent the father's infant from reaching normal developmental milestones will participation, including congenital malformations or prematurity requiring prolonged/ ongoing infant hospitalization.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Anchorage Neighborhood Health Center
Anchorage, Alaska, 99503
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Providence Family Medicine Clinic
Anchorage, Alaska, 99508
About this study
Official title: A Randomized Feasibility and Acceptability Study Comparing In-person to On-line Parenting Education for Adolescent Fathers
This feasibility and acceptability study will compare in-person to web-based parenting education for adolescent fathers on the outcomes of parenting confidence and participation in parenting activities.
Read the detailed description
This is a randomized feasibility and acceptability study using a block generator for randomization of participants aged 15 to 21 into either in-person parenting education or on-line parenting. Outcome measures include parenting self-efficacy and participation in daily parenting activities. Participants will take part in approximately twelve hours of parenting education, whether in-person or on-line. Recruitment flyers will be placed in two primary care clinics and a large regional hospital's Labor \& Delivery and Postpartum (Mother-Baby) Units. Participants will seek out the opportunity to participate by calling the phone number or sending an e-mail to the investigators to learn more about the study and their potential participation. If participants meet eligibility criteria and elect to participate, baseline measurements will be completed after enrollment, with follow-up measures at one month and two months.
- Conditions
- Adolescent, Parenting
- Being tested
- Parenting Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting EducationBehavioural
Parenting education such as positive parenting interactions with their child, knowledge of developmental milestones and interactions with the child to support that development, as well as co-parenting skills will be provided either in-person or on-line to adolescent fathers
| Study group | Role | What they receive |
|---|---|---|
| In-person parenting education | Other | Participants will complete two six-hour in-person parenting education sessions on two consecutive Saturdays Receives: Behavioral: Parenting Education |
| On-line parenting education | Active comparator | Participants will complete on-line parenting education at the times and locations of their choice over a two-week period. Receives: Behavioral: Parenting Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Measure 1
Did recruitment numbers meet goals
Measured: 12 months
Feasibility Measure 2
Attrition rate of participants
Measured: 12 months
Feasibility Measure 3
Percent of data missing from data collection tools
Measured: 12 months
Acceptability Survey Measure 1 (Likert Scale)
Acceptability of learning content to participants
Measured: 12 months
Acceptability Survey Measure 2 (Likert Scale)
Acceptability of time burden to participants
Measured: 12 months
Acceptability Survey Measure 3 (Likert Scale)
Acceptability of learning method to participants
Measured: 12 months
Secondary outcomes (2)
What is the difference between in-person education as compared to on-line parenting education on parental self-efficacy of adolescent fathers as measured by the Parenting Sense of Competence Scale (PSOC)?
Does providing parenting education to adolescent fathers, either in-person or on-line, change their levels of parenting self-efficacy
Measured: 12 months
What is the difference between in-person parenting education as compared to on-line parenting education on participation in parenting activities of adolescent fathers as measured by the Child Care Activities Scale (CCAS)?
Does either in-person or on-line parenting education impact the participation in parenting activities of adolescent fathers?
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start15 Sep 2019
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Adolescent, ParentingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a block randomization generator, participants will be randomized into either in-person or on-line parenting education that will take place over a two week period of time.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Sue Lasiter, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921892
- Sponsor's protocol ID
- 2019000019
- Status last verified
- Nov 2020
- First submitted
- 14 Apr 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savio Beers LA, Hollo RE. Approaching the adolescent-headed family: a review of teen parenting. Curr Probl Pediatr Adolesc Health Care. 2009 Oct;39(9):216-33. doi: 10.1016/j.cppeds.2009.09.001.
PubMed 19857857Kiselica, M. S., & Kiselica, A. M. (2014). The complicated worlds of adolescent fathers: Implications for clinical practice, public policy, and research. Psychology of Men & Masculinity, 15(3), 260-274. doi:10.1037/a0037043
Sevigny PR, Loutzenhiser L. Predictors of parenting self-efficacy in mothers and fathers of toddlers. Child Care Health Dev. 2010 Mar;36(2):179-89. doi: 10.1111/j.1365-2214.2009.00980.x. Epub 2009 Jul 23.
PubMed 19645829Seymour, M., Dunning, M., Cooklin, A., & Giallo, R. (2014). Socioecological factors associated with fathers' well-being difficulties in the early parenting period. Clinical Psychologist, 18(2), 63-73. doi:10.1111/cp.12016
Wilkes L, Mannix J, Jackson D. 'I am going to be a dad': experiences and expectations of adolescent and young adult expectant fathers. J Clin Nurs. 2012 Jan;21(1-2):180-8. doi: 10.1111/j.1365-2702.2011.03715.x. Epub 2011 Jun 5.
PubMed 21645156Rominov H, Giallo R, Whelan TA. Fathers' postnatal distress, parenting self-efficacy, later parenting behavior, and children's emotional-behavioral functioning: A longitudinal study. J Fam Psychol. 2016 Dec;30(8):907-917. doi: 10.1037/fam0000216. Epub 2016 May 16.
PubMed 27183189Love SM, Sanders MR, Turner KM, Maurange M, Knott T, Prinz R, Metzler C, Ainsworth AT. Social media and gamification: Engaging vulnerable parents in an online evidence-based parenting program. Child Abuse Negl. 2016 Mar;53:95-107. doi: 10.1016/j.chiabu.2015.10.031. Epub 2016 Feb 12.
PubMed 26880281Hall CM, Bierman KL. Technology-assisted Interventions for Parents of Young Children: Emerging Practices, Current Research, and Future Directions. Early Child Res Q. 2015 4th Quarter;33:21-32. doi: 10.1016/j.ecresq.2015.05.003. Epub 2015 May 23.
PubMed 27773964Fagan, J., Bernd, E., & Whiteman, V. (2007). Adolescent fathers' parenting stress, social support, and involvement with infants. Journal of Research on Adolescence, 17(1), 1-22. doi:10.1111/j.1532-7795.2007.00510.x
Cronenwett LR, Sampselle CM, Wilson WR. The Child Care Activities Scale and Parental Role Preference Scale. Res Nurs Health. 1988 Oct;11(5):301-8. doi: 10.1002/nur.4770110505.
PubMed 3175054Johnston, C., & Mash, E. J., (1989). A measure of parenting satisfaction and efficacy. Journal of Clinical Child Psychology, 18(2), 167-175
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Feasibility and Acceptability Study Comparing In-person to On-line Parenting Education for Adolescent Fathers
- ClinicalTrials.gov ID
- NCT03921892
- Acronym / sponsor ID
- 2019000019
- Conditions
- Adolescent, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 19 Apr 2019 (actual)
- 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 feasibility and acceptability study will compare in-person to web-based parenting education for adolescent fathers on the outcomes of parenting confidence and participation in parenting activities.
Detailed description
This is a randomized feasibility and acceptability study using a block generator for randomization of participants aged 15 to 21 into either in-person parenting education or on-line parenting. Outcome measures include parenting self-efficacy and participation in daily parenting activities. Participants will take part in approximately twelve hours of parenting education, whether in-person or on-line. Recruitment flyers will be placed in two primary care clinics and a large regional hospital's Labor \& Delivery and Postpartum (Mother-Baby) Units. Participants will seek out the opportunity to participate by calling the phone number or sending an e-mail to the investigators to learn more about the study and their potential participation. If participants meet eligibility criteria and elect to participate, baseline measurements will be completed after enrollment, with follow-up measures at one month and two months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a block randomization generator, participants will be randomized into either in-person or on-line parenting education that will take place over a two week period of time.
| Arm | Type | Receives |
|---|---|---|
| In-person parenting education | Other | Behavioral: Parenting EducationParticipants will complete two six-hour in-person parenting education sessions on two consecutive Saturdays |
| On-line parenting education | Active comparator | Behavioral: Parenting EducationParticipants will complete on-line parenting education at the times and locations of their choice over a two-week period. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- age 15 to 21,
- be able to read and understand English (as determined by having the individual read a brief, eighth grade reading level paragraph),
- able to begin the intervention within six weeks of their infant's birth,
- be able to participate in an intervention over two weeks, requiring approximately a 12-hour time commitment: either in-person on two Saturdays for six hours each, or a self-paced content of videos and resource materials over two weeks,
- own or have access to a device with internet access and
Key exclusion criteria (1 listed)
- Any condition that might prevent the father's infant from reaching normal developmental milestones will participation, including congenital malformations or prematurity requiring prolonged/ ongoing infant hospitalization.
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 |
|---|---|---|
| Parenting EducationParenting education such as positive parenting interactions with their child, knowledge of developmental milestones and interactions with the child to support that development, as well as co-parenting skills will be provided either in-person or on-line to adolescent fathers | Behavioural | In-person parenting education, On-line parenting education |
Primary outcome
Feasibility Measure 1
Time frame: 12 months
Did recruitment numbers meet goals
Feasibility Measure 2
Time frame: 12 months
Attrition rate of participants
Feasibility Measure 3
Time frame: 12 months
Percent of data missing from data collection tools
Acceptability Survey Measure 1 (Likert Scale)
Time frame: 12 months
Acceptability of learning content to participants
Acceptability Survey Measure 2 (Likert Scale)
Time frame: 12 months
Acceptability of time burden to participants
Acceptability Survey Measure 3 (Likert Scale)
Time frame: 12 months
Acceptability of learning method to participants
2 secondary outcomes
What is the difference between in-person education as compared to on-line parenting education on parental self-efficacy of adolescent fathers as measured by the Parenting Sense of Competence Scale (PSOC)?
Time frame: 12 months
What is the difference between in-person parenting education as compared to on-line parenting education on participation in parenting activities of adolescent fathers as measured by the Child Care Activities Scale (CCAS)?
Time frame: 12 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 4 Nov 2020.
- Background: PubMed 19857857Savio Beers LA, Hollo RE. Approaching the adolescent-headed family: a review of teen parenting. Curr Probl Pediatr Adolesc Health Care. 2009 Oct;39(9):216-33. doi: 10.1016/j.cppeds.2009.09.001.
- BackgroundKiselica, M. S., & Kiselica, A. M. (2014). The complicated worlds of adolescent fathers: Implications for clinical practice, public policy, and research. Psychology of Men & Masculinity, 15(3), 260-274. doi:10.1037/a0037043
- Background: PubMed 19645829Sevigny PR, Loutzenhiser L. Predictors of parenting self-efficacy in mothers and fathers of toddlers. Child Care Health Dev. 2010 Mar;36(2):179-89. doi: 10.1111/j.1365-2214.2009.00980.x. Epub 2009 Jul 23.
- BackgroundSeymour, M., Dunning, M., Cooklin, A., & Giallo, R. (2014). Socioecological factors associated with fathers' well-being difficulties in the early parenting period. Clinical Psychologist, 18(2), 63-73. doi:10.1111/cp.12016
- Background: PubMed 21645156Wilkes L, Mannix J, Jackson D. 'I am going to be a dad': experiences and expectations of adolescent and young adult expectant fathers. J Clin Nurs. 2012 Jan;21(1-2):180-8. doi: 10.1111/j.1365-2702.2011.03715.x. Epub 2011 Jun 5.
- Background: PubMed 27183189Rominov H, Giallo R, Whelan TA. Fathers' postnatal distress, parenting self-efficacy, later parenting behavior, and children's emotional-behavioral functioning: A longitudinal study. J Fam Psychol. 2016 Dec;30(8):907-917. doi: 10.1037/fam0000216. Epub 2016 May 16.
- Background: PubMed 26880281Love SM, Sanders MR, Turner KM, Maurange M, Knott T, Prinz R, Metzler C, Ainsworth AT. Social media and gamification: Engaging vulnerable parents in an online evidence-based parenting program. Child Abuse Negl. 2016 Mar;53:95-107. doi: 10.1016/j.chiabu.2015.10.031. Epub 2016 Feb 12.
- Background: PubMed 27773964Hall CM, Bierman KL. Technology-assisted Interventions for Parents of Young Children: Emerging Practices, Current Research, and Future Directions. Early Child Res Q. 2015 4th Quarter;33:21-32. doi: 10.1016/j.ecresq.2015.05.003. Epub 2015 May 23.
- BackgroundFagan, J., Bernd, E., & Whiteman, V. (2007). Adolescent fathers' parenting stress, social support, and involvement with infants. Journal of Research on Adolescence, 17(1), 1-22. doi:10.1111/j.1532-7795.2007.00510.x
- Results publication: PubMed 3175054Cronenwett LR, Sampselle CM, Wilson WR. The Child Care Activities Scale and Parental Role Preference Scale. Res Nurs Health. 1988 Oct;11(5):301-8. doi: 10.1002/nur.4770110505.
- Results publicationJohnston, C., & Mash, E. J., (1989). A measure of parenting satisfaction and efficacy. Journal of Clinical Child Psychology, 18(2), 167-175
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Education in people with Adolescent, Parenting, run by University of Missouri, Kansas City at 3 sites 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 6 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: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Measure 1 (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03921892, which also lists 11 linked publications.
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 4 Nov 2020.