Teen Pregnancy PreventionNCT04451031
Evaluation of the Impact of Linking Families and Teens (LiFT) Curriculum
A study testing LiFT Program in people with Teen Pregnancy Prevention, run by Philliber Research & Evaluation.
Trial summary
To test a new curriculum designed by Planned Parenthood of the Great Northwest and Hawaiian Islands (PPGNHI). The Linking Families and teens (LiFT) curriculum is an innovative program designed for families in rural communities, with the goal of reducing unplanned teen pregnancies by increasing family connectedness and… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- LiFT Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 888 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2016to 25 Feb 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youth must be 13 to 19 years old
- Youth must live in a rural community that has teen pregnancy rates higher than the national average.
- Youth must be accompanied by a parenting adult who agrees to participate in the program. The parenting adult does not need to be the youth's biological parent.
Who cannot join
- Lack of parental consent
- Lack of youth assent
About this study
To test a new curriculum designed by Planned Parenthood of the Great Northwest and Hawaiian Islands (PPGNHI). The Linking Families and teens (LiFT) curriculum is an innovative program designed for families in rural communities, with the goal of reducing unplanned teen pregnancies by increasing family connectedness and increasing youth's self-efficacy, knowledge, and skills related to sexual health.
Read the detailed description
LiFT is a two-module curriculum workshop for youth and their parenting adults. Topics for youth include communication skills, condom use, and skill building to access sexual healthcare resources. For parenting adults, topics include building a climate of trust and open communication with youth about sexual health.
Trained and certified facilitators delivered each 2.5 hour module. Sites could choose to deliver the modules in one or two sessions. Youth and parents participated in simultaneous but separate programming in community locations such as schools or health care settings. Youth and parenting adults also received participant guides that encouraged communication between them. Facilitators encouraged youth and parenting adults to opt-in to receive weekly texts that offer additional resources and suggestions for fun ways families can communicate; these continued for 12 weeks after the workshop. Parenting adults received a phone call from the facilitator 3 to 5 weeks after the workshop to reinforce the skills learned during the program.
Community partners (schools, health care settings, or other community organizations) assisted with recruiting interested dyads of youth and parenting adults from their client base and the community. Each site held a kickoff event or individual meeting or meetings describing the LiFT program in detail.
Over the course of three years, the program was offered 57 times across five cohorts. The program took place in rural communities across nine states; Alaska, California, Hawaii, Idaho, Mississippi, New York, Oregon, Utah, and Washington. The study enrolled 886 dyads for participation.
The LiFT study was a cluster randomized controlled trial. Dyads of youth and their parenting adults were randomly assigned to participate in the intervention or comparison group. Siblings were randomly assigned together within the same condition. At kick-off events or through individual meetings, program staff obtained parental consent and student assent and administered baseline surveys. After receiving consent, assent, and baseline surveys, the research team conducted the random assignment of dyads and informed the site of the results. Program implementation occurred within two weeks of recruitment and baseline data collection.
All study participants were surveyed at two points in time: (1) at the kickoff event or individual meetings before random assignment (baseline) and (2) immediately post-program (3 months from baseline). In addition, youth were surveyed 1 year following baseline. LiFT facilitators administered the baseline surveys, whereas the evaluation team administered the immediate post-program and 9-month post-program follow-up surveys. Surveys were in-person pencil-and-paper surveys for all survey points. Dyads who did not attend in-person follow-up data collection events were contacted and offered multiple options for completing the surveys (for example, by web, over the phone, or via mail).
For the implementation evaluation, the evaluation team collected data on attendance, fidelity, and quality. At the end of each module, LiFT facilitators completed an attendance log, a referral log, and a fidelity form. On the fidelity form, they reported whether they covered all of the topics and activities scheduled for that lesson and any deviations from the planned lesson. Trained observers observed more than 10 percent of all sessions to monitor fidelity and quality. The text messaging service recorded the number of text messages sent and received.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- LiFT Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiFT ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| LiFT Program | Experimental | LiFT is a two-module curriculum workshop for youth and their parenting adults. Topics for youth include communication skills, condom use, and skill building to access sexual healthcare resources. For parenting adults, topics include building a climate of trust and open communication with youth about sexual health. Trained and certified facilitators deliver each 2.5 hour module over one or two sessions. Youth and parents participated in simultaneous but separate programming in community locations such as schools or health care settings. They received participant guides that encourage communication between them. They could opt-in to receive 12 weekly texts that offered additional resources. Parenting adults received a phone call from the facilitator a month after the workshop to reinforce the skills learned during the program. Receives: Behavioral: LiFT Program |
| Comparison Group | No intervention | The comparison group received business as usual. The youth and parents enrolled in the study could receive the existing services available within the broader community, which may have included sexual education delivered in the local school system. Study staff collected data throughout the study to track access to other TPP programming offered at the study sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
No sex or safe sex at last intercourse
This is a computed dichotomous variable (based on a single survey item - "The last time you had vaginal sex, which of these methods of birth control did you or your partner use?") comprised of youth who reported using any of the following: condom, birth control pills, the shot, the patch, the ring, IUD, implant, or never having vaginal sex as Yes (1) and youth who reported either none, not sure, or other (e.g., withdrawal) as No (0).
Measured: 1 year from baseline
Secondary outcomes (3)
No sex or safe sex at last intercourse
This is a computed dichotomous variable (based on a single survey item - "The last time you had vaginal sex, which of these methods of birth control did you or your partner use?") comprised of youth who reported using any of the following: condom, birth control pills, the shot, the patch, the ring, IUD, implant, or never having vaginal sex as Yes (1) and youth who reported either none, not sure, or other (e.g., withdrawal) as No (0).
Measured: 3 months from baseline
Perceived competence in pregnancy prevention scale
5 survey items having the following responses: strongly agree, agree, disagree, strongly disagree. Items are scored with values 1 to 4, where higher numbers indicate the more favorable response.
Items that comprise the scale:
- If someone asked me where to go for pregnancy prevention methods or other sexual health services, I would know where to send them.
- I would feel confident buying condoms or emergency contraception at a drugstore.
- If I needed to go to a health clinic for a pregnancy prevention method, I would feel comfortable doing it.
- I can use condoms correctly
- I can prevent pregnancy easily
An overall scale score is computed (Alpha=0.8371). The overall scale score is presented on a scale of 0 to 100% based on the percent of the total score possible for the scale.
Measured: 3 months from baseline
Parent child communication about sexuality and pregnancy prevention scale
6 survey items having the following responses: never, once, 2-3 times, 4-5 times, and 6 or more times. Items are scored with values 1 to 5.
The items included in the scale:
In the past 3 months, how often have you talked with your parenting adult about each of the following topics?
- Your parenting adult(s) values regarding sex and sexuality
- Your thoughts and feelings on sex and sexuality
- Dating and relationships
- Preventing pregnancy and/or STDs and HIV
- Consent and saying no to things you don't want sexually
- How to use or get condoms or other birth control
An overall scale score is computed (Alpha=0.8681). The overall scale score is presented on a scale of 0 to 100% based on the percent of the total score possible for the scale.
Measured: 3 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start5 Oct 2016
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen Pregnancy PreventionStudies 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
- 888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philliber Research & Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS
- Responsible party
- Principal investigator, Sally Brown, Philliber Research & Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451031
- Sponsor's protocol ID
- Pro00017127
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 30 Jun 2020
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Linking Families and Teens (LiFT) Curriculum
- ClinicalTrials.gov ID
- NCT04451031
- Acronym / sponsor ID
- Pro00017127
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 888 participants (actual)
- Lead sponsor
- Philliber Research & EvaluationUniversity, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 30 Jun 2020 (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.
To test a new curriculum designed by Planned Parenthood of the Great Northwest and Hawaiian Islands (PPGNHI). The Linking Families and teens (LiFT) curriculum is an innovative program designed for families in rural communities, with the goal of reducing unplanned teen pregnancies by increasing family connectedness and increasing youth's self-efficacy, knowledge, and skills related to sexual health.
Detailed description
LiFT is a two-module curriculum workshop for youth and their parenting adults. Topics for youth include communication skills, condom use, and skill building to access sexual healthcare resources. For parenting adults, topics include building a climate of trust and open communication with youth about sexual health.
Trained and certified facilitators delivered each 2.5 hour module. Sites could choose to deliver the modules in one or two sessions. Youth and parents participated in simultaneous but separate programming in community locations such as schools or health care settings. Youth and parenting adults also received participant guides that encouraged communication between them. Facilitators encouraged youth and parenting adults to opt-in to receive weekly texts that offer additional resources and suggestions for fun ways families can communicate; these continued for 12 weeks after the workshop. Parenting adults received a phone call from the facilitator 3 to 5 weeks after the workshop to reinforce the skills learned during the program.
Community partners (schools, health care settings, or other community organizations) assisted with recruiting interested dyads of youth and parenting adults from their client base and the community. Each site held a kickoff event or individual meeting or meetings describing the LiFT program in detail.
Over the course of three years, the program was offered 57 times across five cohorts. The program took place in rural communities across nine states; Alaska, California, Hawaii, Idaho, Mississippi, New York, Oregon, Utah, and Washington. The study enrolled 886 dyads for participation.
The LiFT study was a cluster randomized controlled trial. Dyads of youth and their parenting adults were randomly assigned to participate in the intervention or comparison group. Siblings were randomly assigned together within the same condition. At kick-off events or through individual meetings, program staff obtained parental consent and student assent and administered baseline surveys. After receiving consent, assent, and baseline surveys, the research team conducted the random assignment of dyads and informed the site of the results. Program implementation occurred within two weeks of recruitment and baseline data collection.
All study participants were surveyed at two points in time: (1) at the kickoff event or individual meetings before random assignment (baseline) and (2) immediately post-program (3 months from baseline). In addition, youth were surveyed 1 year following baseline. LiFT facilitators administered the baseline surveys, whereas the evaluation team administered the immediate post-program and 9-month post-program follow-up surveys. Surveys were in-person pencil-and-paper surveys for all survey points. Dyads who did not attend in-person follow-up data collection events were contacted and offered multiple options for completing the surveys (for example, by web, over the phone, or via mail).
For the implementation evaluation, the evaluation team collected data on attendance, fidelity, and quality. At the end of each module, LiFT facilitators completed an attendance log, a referral log, and a fidelity form. On the fidelity form, they reported whether they covered all of the topics and activities scheduled for that lesson and any deviations from the planned lesson. Trained observers observed more than 10 percent of all sessions to monitor fidelity and quality. The text messaging service recorded the number of text messages sent and received.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiFT Program | Experimental | Behavioral: LiFT ProgramLiFT is a two-module curriculum workshop for youth and their parenting adults. Topics for youth include communication skills, condom use, and skill building to access sexual healthcare resources. For parenting adults, topics include building a climate of trust and open communication with youth about sexual health. Trained and certified facilitators deliver each 2.5 hour module over one or two sessions. Youth and parents participated in simultaneous but separate programming in community locations such as schools or health care settings. They received participant guides that encourage communication between them. They could opt-in to receive 12 weekly texts that offered additional resources. Parenting adults received a phone call from the facilitator a month after the workshop to reinforce the skills learned during the program. |
| Comparison Group | No intervention | –The comparison group received business as usual. The youth and parents enrolled in the study could receive the existing services available within the broader community, which may have included sexual education delivered in the local school system. Study staff collected data throughout the study to track access to other TPP programming offered at the study sites. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Youth must be 13 to 19 years old
- Youth must live in a rural community that has teen pregnancy rates higher than the national average.
- Youth must be accompanied by a parenting adult who agrees to participate in the program. The parenting adult does not need to be the youth's biological parent.
Key exclusion criteria (2 listed)
- Lack of parental consent
- Lack of youth assent
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 |
|---|---|---|
| LiFT Program | Behavioural | LiFT Program |
Primary outcome
No sex or safe sex at last intercourse
Time frame: 1 year from baseline
This is a computed dichotomous variable (based on a single survey item - "The last time you had vaginal sex, which of these methods of birth control did you or your partner use?") comprised of youth who reported using any of the following: condom, birth control pills, the shot, the patch, the ring, IUD, implant, or never having vaginal sex as Yes (1) and youth who reported either none, not sure, or other (e.g., withdrawal) as No (0).
3 secondary outcomes
No sex or safe sex at last intercourse
Time frame: 3 months from baseline
Perceived competence in pregnancy prevention scale
Time frame: 3 months from baseline
Parent child communication about sexuality and pregnancy prevention scale
Time frame: 3 months from baseline
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 30 Jun 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing LiFT Program in people with Teen Pregnancy Prevention, run by Philliber Research & Evaluation.
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 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 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
No sex or safe sex at last intercourse (time frame: 1 year from baseline). 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 30 Jun 2020.