CClinicalTrials.gg
CompletedNCT04451031Updated Jun 30, 2020

Evaluation of the Impact of Linking Families and Teens (LiFT) Curriculum

An interventional study of LiFT Program in Teen Pregnancy Prevention, sponsored by Philliber Research & Evaluation. Completed. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by Philliber Research & Evaluation · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Oct 2016, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
888
Allocation
Randomized
Ages
13 Years to 19 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Teen Pregnancy Prevention
03

In context

Lead sponsor

Philliber Research & Evaluation is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Youth must be 13 to 19 years old
  2. Youth must live in a rural community that has teen pregnancy rates higher than the national average.
  3. 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.

Exclusion criteria

Exclusion Criteria:

  1. Lack of parental consent
  2. Lack of youth assent
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
888 participants (actual)

Study arms

  • Experimental
    LiFT Program

    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.

    Behavioral: LiFT Program

  • No intervention
    Comparison Group

    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.

Interventions

  • BehavioralLiFT Program
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 year from baseline

Secondary outcomes

  1. 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).

    Time frame: 3 months from baseline

  2. 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: 1. If someone asked me where to go for pregnancy prevention methods or other sexual health services, I would know where to send them. 2. I would feel confident buying condoms or emergency contraception at a drugstore. 3. If I needed to go to a health clinic for a pregnancy prevention method, I would feel comfortable doing it. 4. I can use condoms correctly 5. 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.

    Time frame: 3 months from baseline

  3. 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? 1. Your parenting adult(s) values regarding sex and sexuality 2. Your thoughts and feelings on sex and sexuality 3. Dating and relationships 4. Preventing pregnancy and/or STDs and HIV 5. Consent and saying no to things you don't want sexually 6. 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.

    Time frame: 3 months from baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04451031
Lead sponsor
Philliber Research & Evaluation
Collaborators
The Office of Adolescent Health, HHS
Responsible party
Sally Brown (Senior Research Associate, Philliber Research & Evaluation) — Principal investigator
First posted
Jun 30, 2020
Start date
Oct 5, 2016
Primary completion
Feb 25, 2020
Completion
Feb 25, 2020
Last update
Jun 30, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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