Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03849703 |
| Other study ID # |
90FM0067-01-01 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2016 |
| Est. completion date |
September 29, 2020 |
Study information
| Verified date |
April 2019 |
| Source |
Texas State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
An intent-to-treat randomized design coupled with a time-series design will be used to assess
differential adjustment between the treatment and control groups, and to assess differential
changes in adjustment between adolescent parents across four time-points. A block
randomization design will be used to randomly assign eight participating schools into one of
four treatment conditions based on curriculum assignment. Schools can receive a co-parenting
(COPAR), healthy romantic relationship (HRR), and/or a control (CONT) curriculum each
semester. Treatment conditions reflect schools which receive a full treatment model (i.e.,
COPAR-HRR, HRR-COPARE) or a partial treatment model (i.e., COPAR-CONT, and HRR-CONT). The
investigators hypothesize that youth participating in the full-treatment group will show
statistically significant immediate and sustained improvements in well-being, as well as
larger improvements in their co-parenting and relationship knowledge and behaviors post
treatment and more sustained improvements in co-parenting and relationship behaviors six
months post-treatment than youth in the partial-treatment group. Couples in the program will
show better co-parenting and relationship outcomes than couples where only one adolescent
participated.
Description:
Background The development of healthy romantic relationship skills and supportive
co-parenting skills are important to family functioning and parental well-being. Family
systems perspective and co-parental frameworks suggest these two relationships are related
but distinct; however, curricula targeting family functioning do not target both relationship
dynamics. A possible reason for this oversight may be that co-parenting curricula have been
created for adult couples (e.g., Bringing Baby Home, Family Expectations, Family Foundations,
Two Families Now; National Registry of Evidence-Based Programs and Practices [NREPP]).
Similarly, healthy relationship programs have been targeted towards adolescents and emerging
adults, or premarital couple where co-parenting was not given substantial attention.
Only two co-parenting curricula exist that target adolescent parents, the Young Parenthood
Program (YPP) and the Family Foundations program (FFP). YPP states that it targets
co-parenting skills, but the material actually targets healthy romantic relationship skills
and the prevention of intimate partner violence (IPV), acknowledging youth developmental need
to learn healthy relationship skills, but ignoring the saliency of co-parenting in this
unique context. FFP does target the co-parenting relationship by focusing on identifying
childrearing goals and duties and supporting the co-parental relationship; however, this
program does not target healthy relationship dynamics or the prevention of IPV.
Unfortunately, adolescent parents, who are experiencing an off-time transition into early
parenthood, face the challenge of learning to positively engage in romantic and co-parental
relationships at the same time. To better serve this population, the Strengthening
Relationships/ Strengthening Families (SR/SF) program is targeting healthy relationship and
supportive co-parenting skills. Because a program targeting both skills has not been
implemented in any population, our evaluation will move the field forward by showcasing the
efficacy of targeting two family relationship dynamics concurrently. Further, by comparing a
full-treatment (co-parenting and healthy relationships) to partial-treatment groups
(co-parenting only or healthy relationship only), the investigators will be able to identify
which relationship is more salient and impactful in increasing adolescent (e.g., depression,
self-esteem, role overload) and parental (e.g., parental stress, parental self-efficacy)
adjustment during this off-time transition into parenthood. Finally, cost-effectiveness
analysis will also provide information of the program impacts if services are provided to one
or both members of the co-parental system. Taken together, the program model and supporting
evaluation will help build our knowledge of the most salient needs of adolescent parents, and
program service delivery best practices.
Evaluation Questions and Hypotheses
Due to the lacuna in the literature focused on adolescent parents and their coparenting
adjustment, the following research questions have been formulated:
1. Do pregnant and parenting adolescents who participate in the full-treatment group
(Co-parenting AND Healthy Relationships) show larger improvements in their co-parenting
and relationship knowledge and behaviors compared to those adolescents who participate
in the partial-treatment group (Co-parenting OR Healthy Relationships)? H1: Youth
participating in the full-treatment group will show larger improvements in their
co-parenting and relationship knowledge and behaviors post treatment compared to youth
in the partial-treatment group.
2. Do pregnant and parenting adolescents who participate in the full-treatment group show
sustained improvements in co-parenting and relationship behaviors six-months
post-treatment? H1: Youth participating in the full-treatment group will show more
sustained improvements in co-parenting and relationship behaviors six months
post-treatment than youth in the partial-treatment group.
3. Do couples who participate show significantly better co-parenting and relationship
outcomes than couples where only one adolescent participated? (cost-effectiveness
analysis) H1: Couples in the program will show better co-parenting and relationship
outcomes than couples where only one adolescent participated.
4. Do pregnant and parenting adolescents who participate in the full-treatment group show
immediate (post-treatment) and sustained (3- & 6-month follow-up) improvements in
well-being (i.e., reduced depressive symptoms, role overload, increased parental
self-efficacy)? H1: Youth participating in the full-treatment group will show
statistically significant immediate and sustained improvements in well-being.
Impact Evaluation An intent-to-treat randomized design coupled with a time-series design will
be used to assess differential adjustment between the treatment and control groups, and to
assess differential changes in adjustment between groups across four time-points. SR/SF
participants will be recruited to participate in this evaluation (See Sample Section below).
In addition, non-SR/SF participant adolescent fathers will be recruited to participate in the
evaluation to serve as a non-random control group. The time-series design will be
administered pre-treatment (early Fall semester: August), mid-treatment (end of Fall
semester: December; participants only), post-treatment (end of Spring semester: May), and
three-months post-treatment (August). Each school year, data will be collected from a new
cohort of participating pregnant/parenting adolescents (nparticipant/cohort = 160-200) and
non-intervention fathers (nnon-participant/cohort = 40-50) for a total of four cohorts
(nparticipant = 640-800; nnon-participant = 160-200).
Sample All students participating in our program beginning Fall 2016 will be invited to
participate in this evaluation with the primary unit of analysis being the adolescent parent.
The investigators will recruit 160-200 students/year for a total of 640-800 participants
across four years. Our program participants are projected to be primarily female (75%),
Hispanic (91%), pregnant and parenting (32% pregnant, 78% parenting) adolescents between the
ages of 14-20, with an additional 40 adolescent fathers/year recruited (by the evaluation
team) to serve as the non-equivalent control group for Research Question #3. Regardless of
group membership, 440-550 adolescents will receive the co-parenting curriculum, and 440-550
adolescents will receive the healthy romantic relationship curriculum. Given our previous
success in sample retention, less than 20% attrition is expected. However, our
intent-to-treat design and missing data handling techniques will allow us to use the full
sample in our analyses.
