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Relational ProblemsNCT05722574

Project Relate: Romantic Relationship Competence SSI

A study testing Romantic Competence Intervention in people with Relational Problems and Depression, run by Stony Brook University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 20 years
Conditions the study is for
Relational Problems, Depression
What is being tested?
Romantic Competence Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
No sites listed yet
Study dates
Feb 2023to Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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])

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Jessica Schleider, PhD contact

(631) 632-4131

jessica.schleider@stonybrook.edu

Atina Manvelian, PhD contact

atina.manvelian@stonybrook.edu

About this study

Official title: 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.

Being tested
Romantic Competence Intervention, Information Only Control Condition
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Romantic Competence InterventionBehavioural

    Online, 30-minute self-administered relationship competence program for youth ages 16-20

  • Information Only Control ConditionBehavioural

    Online, 30-minute self-administered relationship education activity for youth ages 16-20

Study groups in NCT05722574
Study groupRoleWhat they receive
Information Only Control ConditionActive comparatorThe 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.
Receives: Behavioral: Information Only Control Condition
Romantic Competence InterventionExperimentalThe 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.
Receives: Behavioral: Romantic Competence Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)

    The PHQ-9 is a reliable, valid measure of depression symptom severity. Higher scores indicate more severe symptoms of depression.

    Measured: Pre-SSI to 3-month follow-up

Secondary outcomes (6)

  1. Beck Hopelessness Scale - 4 Item Version (Steed, 2001)

    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.

    Measured: Pre-Intervention to Immediately Post-Intervention; Pre-Intervention to 3-month follow-up

  2. Relationship Learning Inventory (Davila et al., 2000)

    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.

    Measured: Pre-Intervention to Immediately Post-Intervention

  3. Generalized Anxiety Disorder (GAD-7; Steed, 2001)

    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.

    Measured: Pre-SSI to 3-month follow-up

  4. Relationship Decision Making Scale (Vennum & Fincham, 2011)

    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.

    Measured: Pre-SSI to 3-month follow-up

  5. Relationship Knowledge and Efficacy Scale (Davila et al., 2020)

    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.

    Measured: Pre-SSI to 3-month follow-up

  6. Qualitative Changes in the Relationship Learning Inventory

    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.

    Measured: Immediately Post-Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study startFeb 2023 (estimated)
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to either the intervention condition or the information-only control group.
Masking
Single blind
Who is masked
Participant
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05722574
Sponsor's protocol ID
IRB2022-00262
Status last verified
Feb 2023
First submitted
1 Feb 2023
Last updated
14 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After our trial has ended, data without any identifying markers will be made available to researchers interested in our dataset.

Publications

  • Avenevoli S, Swendsen J, He JP, Burstein M, Merikangas KR. Major depression in the national comorbidity survey-adolescent supplement: prevalence, correlates, and treatment. J Am Acad Child Adolesc Psychiatry. 2015 Jan;54(1):37-44.e2. doi: 10.1016/j.jaac.2014.10.010. Epub 2014 Oct 29.

    PubMed 25524788

  • Marques de Miranda D, da Silva Athanasio B, Sena Oliveira AC, Simoes-E-Silva AC. How is COVID-19 pandemic impacting mental health of children and adolescents? Int J Disaster Risk Reduct. 2020 Dec;51:101845. doi: 10.1016/j.ijdrr.2020.101845. Epub 2020 Sep 10.

    PubMed 32929399

  • Schleider JL, Weisz JR. Little Treatments, Promising Effects? Meta-Analysis of Single-Session Interventions for Youth Psychiatric Problems. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):107-115. doi: 10.1016/j.jaac.2016.11.007. Epub 2016 Nov 25.

    PubMed 28117056

  • Osborn TL, Rodriguez M, Wasil AR, Venturo-Conerly KE, Gan J, Alemu RG, Roe E, Arango G S, Otieno BH, Wasanga CM, Shingleton R, Weisz JR. Single-session digital intervention for adolescent depression, anxiety, and well-being: Outcomes of a randomized controlled trial with Kenyan adolescents. J Consult Clin Psychol. 2020 Jul;88(7):657-668. doi: 10.1037/ccp0000505. Epub 2020 May 11.

    PubMed 32391709

  • Schleider JL, Mullarkey MC, Fox KR, Dobias ML, Shroff A, Hart EA, Roulston CA. A randomized trial of online single-session interventions for adolescent depression during COVID-19. Nat Hum Behav. 2022 Feb;6(2):258-268. doi: 10.1038/s41562-021-01235-0. Epub 2021 Dec 9.

    PubMed 34887544

  • Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.

    PubMed 21697139

  • Zhang WC, Jia CX, Hu X, Qiu HM, Liu XC. Beck Hopelessness Scale: Psychometric Properties Among Rural Chinese Suicide Attempters and Non-Attempters. Death Stud. 2015;39(7):442-6. doi: 10.1080/07481187.2014.970300. Epub 2015 Feb 13.

    PubMed 25679324

  • Ahlen J, Ghaderi A. Evaluation of the Children's Depression Inventory-Short Version (CDI-S). Psychol Assess. 2017 Sep;29(9):1157-1166. doi: 10.1037/pas0000419. Epub 2016 Dec 5.

    PubMed 27918174

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Davila J, Zhou J, Norona J, Bhatia V, Mize L, Lashman K. Teaching romantic competence skills to emerging adults: A relationship education workshop. Pers Relatsh. 2021;28(2):251-275. doi:10.1111/pere.12366

  • Davila J, Mattanah J, Bhatia V, et al. Romantic competence, healthy relationship functioning, and well-being in emerging adults. Pers Relatsh. 2017;24(1):162-184. doi:10.1111/pere.12175

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

Questions about this trial

What is this clinical trial studying?

A study testing Romantic Competence Intervention in people with Relational Problems and Depression, run by Stony Brook University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jessica Schleider, PhD ((631) 632-4131, jessica.schleider@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) (time frame: Pre-SSI to 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05722574, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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