NCT04451031

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
888

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

3.4 years

First QC Date

June 19, 2020

Last Update Submit

June 25, 2020

Conditions

Outcome Measures

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).

    1 year from baseline

Secondary Outcomes (3)

  • No sex or safe sex at last intercourse

    3 months from baseline

  • Perceived competence in pregnancy prevention scale

    3 months from baseline

  • Parent child communication about sexuality and pregnancy prevention scale

    3 months from baseline

Study Arms (2)

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.

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.

Interventions

LiFT ProgramBEHAVIORAL
LiFT Program

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Lack of parental consent
  • Lack of youth assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Associate

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 30, 2020

Study Start

October 5, 2016

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

June 30, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share