Project Relate: Romantic Relationship Competence SSI

February 10, 2023 updated by: Jessica Schleider, Stony Brook University

Project Relate: Romantic Relationship Competence Single-Session Intervention Trial

The COVID-19 pandemic has increased social isolation and depressive symptoms in youth, adding strain to an already overwhelmed mental healthcare system. Online single-session interventions are digital programs that can help expand access to care and teach evidence-based skills. To help youth build healthy relationships, we developed 3 online single-session interventions (SSI) to teach romantic competence skills to adolescents and emerging adults. Youth, ages 16-20, will be recruited to social media and randomly assigned to one of two conditions: the intervention condition, offering them three SSIs to select from, or an information-only control group. Within the intervention condition, youth will complete one of three romantic competence SSIs: (1) Insight, targeting awareness of one's needs in relationships, (2) Communication, teaching listening and communication skills, and (3) Stay vs. Go, helping youth make difficult decisions. Investigators will assess each SSI's relative benefits on relationship knowledge and depressive symptoms up to three months later compared to the information-only control group. Results will reveal if online SSIs can teach romantic competence skills and if engaging in these interventions has psychosocial benefits for youth with elevated depressive symptoms.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • are fluent in English
  • have consistent internet and computer/laptop/smartphone access
  • report elevated depressive symptoms (a score of >2 on the Patient Health Questionnaire-2 item version [PHQ-2])

Exclusion Criteria:

  • fail to meet the above-listed inclusion criteria
  • exit the study prior to condition randomization
  • respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
  • obvious lack of English fluency in open response questions
  • responding with random text in open response questions
  • duplicate responses from the same individual in baseline or follow-up surveys

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Information Only Control Condition
The information only control condition is designed to mimic relationship education that could be easily found online by adolescents. This condition does not teach romantic competence skills such as insight, communication/mutuality, or emotion regulation skills; rather, it focuses on educating subjects about the healthy and unhealthy signs of a romantic relationship. In addition, this condition is designed to control for nonspecific aspects of the intervention, such as engaging in an online program and taking time to reflect on one's relationships.
Behavioral: Information Only Control Condition
Online, 30-minute self-administered relationship education activity for youth ages 16-20
EXPERIMENTAL: Romantic Competence Intervention
The Romantic Competence Single-Session Intervention provides adolescents with the opportunity to learn one of three relational skills online: (1) Insight, the ability to understand what one needs in relationships and act in alignment with one's needs, (2) Communication, the capacity to listen to others and express one's needs effectively, and (3) Stay vs. Go, the ability to reflect and make difficult decisions in relationships. Adolescents are presented with the opportunity to choose which module they would like to complete. Each module has the following components: psychoeducation, a personalized action plan, and practice overcoming barriers.
Behavioral: Romantic Competence Intervention
Online, 30-minute self-administered relationship competence program for youth ages 16-20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
Time Frame: Pre-SSI to 3-month follow-up
The PHQ-9 is a reliable, valid measure of depression symptom severity. Higher scores indicate more severe symptoms of depression.
Pre-SSI to 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Hopelessness Scale - 4 Item Version (Steed, 2001)
Time Frame: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
This scale asks participants to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Average scores across all items range from 0 to 3, with a higher score indicating greater levels of hopelessness.
Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up
Relationship Learning Inventory (Davila et al., 2000)
Time Frame: Pre-Intervention to Immediately Post-Intervention
This measure uses 3 questions post-intervention to assess the extent to which participants gained learned something important after the activity, thought about relationships differently, or felt validated in the way that they have been thinking/acting in their relationships.
Pre-Intervention to Immediately Post-Intervention
Generalized Anxiety Disorder (GAD-7; Steed, 2001)
Time Frame: Pre-SSI to 3-month follow-up
The GAD-7 measures the severity of clinical anxiety symptoms, based on diagnostic criteria for generalized anxiety disorder. The GAD-7 includes 7 items asking respondents how often, during the last 2 weeks, they were bothered by each of 7 anxiety symptoms. Higher scores reflect higher generalized anxiety symptoms.
Pre-SSI to 3-month follow-up
Relationship Decision Making Scale (Vennum & Fincham, 2011)
Time Frame: Pre-SSI to 3-month follow-up
The Relationship Deciding Scale measures effective decision-making during interpersonal situations. It has three subscales with items rated on a 5- point scale (1 = strongly disagree, 5 = strongly agree), relationship confidence, assessing confidence in maintaining a relationship; warning signs, assessing awareness of and ability to deal with warning signs in relationships; and deciding, assessing thoughtfulness regarding decisions. Higher scores suggest more effective decision-making.
Pre-SSI to 3-month follow-up
Relationship Knowledge and Efficacy Scale (Davila et al., 2020)
Time Frame: Pre-SSI to 3-month follow-up
This measure consists of 21 items, rated 1-7 (1 = strongly disagree, 7 = strongly agree), and measures six domains: (1) confidence in one's knowledge about what a healthy relationship is and ability to manage relationships; (2) confidence in one's knowledge about and ability to cope with relationship problems; (3) willingness to compromise oneself; (4) beliefs that any relationship can work if you work hard enough; and (5) overreliance on emotions for relationship decisions. Higher scores reflect better relationship knowledge and efficacy.
Pre-SSI to 3-month follow-up
Qualitative Changes in the Relationship Learning Inventory
Time Frame: Immediately Post-Intervention
Immediately after the activity, participants will be asked, "In your opinion, what was the most important thing you learned from this activity?" "Based on what you learned, will you do anything differently in your relationships? If yes, please elaborate on what you will do differently." At the 3-month follow-up, we also ask two additional questions, "From what you remember, what was the most important thing you learned in our relationship education activity?" and "Since completing this activity, have you noticed any changes in how you navigate your relationships? If yes, please tell us what you have noticed." Participants are provided with space to answer these questions via text entry.
Immediately Post-Intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program Feedback Scale
Time Frame: Pre-Intervention to Immediately Post-Intervention
The PFS asks youth to rate agreement with 7 statements indicating perceived acceptability of an SSI (e.g. "I enjoyed the program") on a 5-point Likert scale (1="really disagree"; 5="totally agree"). A score of 3.5/5 or above on any given PFS item is interpreted as an "acceptable" rating on that item. Scores are calculated at the item-level, and higher scores reflect greater acceptability for each item.
Pre-Intervention to Immediately Post-Intervention
UCLA Loneliness Scale
Time Frame: Pre-SSI to 3-month follow-up
The ULS is a widely used self-report scale of loneliness. The brief 3-item version will be used here. Participants will rate agreement with 3 items reflecting loneliness (e.g. "I feel left out"; "I feel isolated from others"). Higher scores reflect higher levels of loneliness.
Pre-SSI to 3-month follow-up
Perceived Changes
Time Frame: Immediately Post-Intervention

Participants are asked 3 questions about perceived changes in mood, hopelessness, and problem-solving capabilities. "Compared to before doing this activity, to what extent are you feeling hopeless right now?" Items are rated 1-5 (1 = much more hopeless, 5 = much less hopeless).

Compared to before doing this activity, what is your mood like right now?" Items are rated 1-5 (1 = much worse, 5 = much better).

"Compared to before doing this activity, to what extent are you able to solve the problems facing you right now?" Items are rated 1-5 (1 = much less able to solve problems, 5 = a lot more able to solve problems).
Immediately Post-Intervention
Global/General Attachment (ECR-RS, 9-item Version; Fraley et al., 2015)
Time Frame: Pre-SSI to 3-month follow-up
The Relationship Structures Questionnaire is a self-report measure that assesses general attachment patterns across a variety of close relationships. It asks participants to rate the extent to which each statement describes their feelings about close relationships in general. This abbreviated measure consists of 9 items, ranking from 1 (Strongly Disagree) to 7 (Strongly Agree). This measure consists of two subscales: anxiety and avoidance. Higher scores on the anxiety and avoidance subscales represent higher levels of attachment insecurity.
Pre-SSI to 3-month follow-up
Interpersonal Reactivity Index (Peloquin & Lafontaine, 2010).
Time Frame: Pre-SSI to 3-month follow-up
We assessed empathy and perspective-taking with the two subscales of the Interpersonal Reactivity Index (IRIC; Péloquin & Lafontaine; 2010); this measure was only administered to youth who were dating or in a committed romantic relationship. Items rated on a 5-point scale (0 = does not describe me well, 4 = describes me very well). Example items for perspective taking include, "When I'm upset at my partner, I usually try to 'put myself in his/her shoes' for a while" and empathic concern, " I often have tender, concerned feelings for my partner when he/she is less fortunate than me." Participants were instructed to 'Answer about your current or most recent partner,' and higher scores reflect higher levels of empathy and perspective-taking, respectively.
Pre-SSI to 3-month follow-up
Couple Satisfaction Index (CSI-4; Funk & Rogge, 2007).
Time Frame: Pre-SSI to 3-month follow-up
We used the 4-item measure from the Couple Satisfaction Index to measure relationship satisfaction; this measure was administered to youth who were dating or in a committed romantic relationship. Items include questions like "How rewarding is your relationship with your partner?" and "In general, how satisfied are you with your relationship?" Items are ranked 0- Not at all to 5- Completely. CSI-4 scores can range from 0 to 21. Higher scores indicate higher levels of relationship satisfaction.
Pre-SSI to 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2023

Primary Completion (ANTICIPATED)

July 1, 2023

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 10, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2022-00262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After our trial has ended, data without any identifying markers will be made available to researchers interested in our dataset.

IPD Sharing Time Frame

Deidentified data will be made available on the Open Science Framework within one year of publishing study results.

IPD Sharing Access Criteria

Access will not be restricted.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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