NCT03849703

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Status
unknown

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

August 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

3.8 years

First QC Date

March 6, 2018

Last Update Submit

April 9, 2019

Conditions

Keywords

Adolescent parentscoparentingromantic relationships

Outcome Measures

Primary Outcomes (3)

  • Attitudes & Knowledge

    The HMRE nFORM pre- and post-test surveys will be used to assess changes in attitudes towards marriage (Section A1), healthy relationships (Section A3), romantic relationship conflict resolution (Section A4), and intimate partner violence (Section A5).

    1 year

  • Romantic Relationship Adjustment - Conflict Resolution

    Abusive behaviors between dating adolescents will be assessed using the Conflict in Adolescent Dating Relationships Inventory (CADRI; Wolfe et al., 2001). Physical, sexual, emotional, verbal, and threatening behaviors are assessed in this 31-item measure. The CADRI has demonstrated acceptable test-retest reliability, good internal consistency, and agreement between dating partners (Wolfe, et al., 2001).

    1 year

  • Coparenting Adjustment - Communication

    Two subscales from the Co-parental Communication Scale (Ahrons, 1981) will be used to assess frequency of communication (7-item) and degree of conflict (7-item) that is present when discussing parenting issues between co-parents. This scale has been modified and validated with Mexican adolescent mothers (Madden-Derdich, 2002; Herzog, Umaña-Taylor, Madden-Derdich, \& Leonard, 2007) with good reliability in both subscales (α \> .78).

    1 year

Secondary Outcomes (2)

  • Parenting - Involvement

    1 year

  • Psychosocial functioning - Self-esteem

    1 year

Study Arms (4)

Full Intervention #1

EXPERIMENTAL

Participants will receive both of our target curricula but in alternate order. This treatment group will receive the coparenting curriculum before the romantic relationships curriculum.

Behavioral: Full Intervention #1

Full Intervention #2

EXPERIMENTAL

Participants will receive both of our target curricula but in alternate order. This treatment group will receive the romantic relationships curriculum before the coparenting curriculum.

Behavioral: Full Intervention #2

Partial Intervention #1

OTHER

Participants will receive the romantic relationships curriculum along with the control curriculum.

Behavioral: Partial Intervention #1

Partial Intervention #2

OTHER

Participants will receive the coparenting curriculum along with the control curriculum.

Behavioral: Partial Intervention #2

Interventions

Participants will receive 10 lessons on a weekly basis per semester for two semesters, for a total of 20 lessons. This Intervention group will receive the coparenting and then romantic relationship curricula. The lessons last between 45-60 minutes and are based on evidence based curricula.

Full Intervention #1

Participants will receive 10 lessons on a weekly basis per semester for two semesters, for a total of 20 lessons. This Intervention group will receive the romantic relationship and then coparenting curricula. The lessons last between 45-60 minutes and are based on evidence based curricula.

Full Intervention #2

Participants will receive 10 lessons on a weekly basis per semester for two semesters, for a total of 20 lessons. This Partial Intervention group will receive the romantic relationship curriculum and a control curriculum. The lessons last between 45-60 minutes and are based on evidence based curricula.

Partial Intervention #1

Participants will receive 10 lessons on a weekly basis per semester for two semesters, for a total of 20 lessons. This Partial Intervention group will receive the coparenting curriculum and a control curriculum. The lessons last between 45-60 minutes and are based on evidence based curricula.

Partial Intervention #2

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • pregnant or parenting (biological and nonbiological parents)
  • adolescents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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-COPAR) or a partial treatment model (i.e., COPAR-CONT, and HRR-CONT).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2018

First Posted

February 21, 2019

Study Start

August 1, 2016

Primary Completion

May 31, 2020

Study Completion

September 29, 2020

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share