Mental Health Wellness 1NCT05582057
Strengths to Grow - Preteen: An Online Parenting Resource
A study testing Strengths to Grow: Preteen in people with Mental Health Wellness 1, run by University of Guelph at 1 site in Canada.
Trial summary
Research suggests that strength-based parenting programs can enhance family well-being, but the current formats of these programs (e.g., in-person workshops) are not accessible to many families. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Strengths to Grow: Preteen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2022to May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent of a child(ren) who is enrolled in Grade 4 to 8 at the Upper Grand District School Board in Guelph, Ontario
- Able to read and write in English (linguistic proficiency equivalent to a Grade 8 reading level or greater)
- Consent to participate in the research study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Upper Grand District School Board
Guelph, Ontario, N1E 6K2
Margaret Lumley, PhD, 519-824-4120 ext. 53486, MLUMLEY@UOGUELPH.CA
About this study
Official title: Strengths to Grow Preteen: An Online Parenting Resource
Research suggests that strength-based parenting programs can enhance family well-being, but the current formats of these programs (e.g., in-person workshops) are not accessible to many families. The first aim of the study is to adapt Strengths to Grow, an accessible and engaging strength-based parenting program, for pre-teens. The second aim of the study is to assess the effectiveness this adapted program (Strengths to Grow: Preteen). Toward this end, parents of children in Grades 4 through 8 will be invited to complete a brief, online survey of well-being before and a few weeks after completing the online program to assess its impact on well-being.
Read the detailed description
Strength-based Parenting Strength-based parenting is a style of caregiving which identifies and cultivates strengths in the child and caregiver. When parents employ a strength-based parenting style, youth tend to demonstrate greater academic achievement, resilience, and overall well-being, and parents tend to experience more well-being within the caregiving role. Additionally, it is believed that caregivers can develop a strength-based parenting style through training and practice. For these reasons, several strength-based parenting programs have been developed.
Character Strengths Strength-based parenting programs typically focus on helping parents to identify and develop a particular type of strength known as character strengths. Character strengths are personal qualities that are widely regarded as morally good (e.g., bravery, curiosity, kindness). In 2004, Peterson and Seligman completed a comprehensive review that identified 24 character strengths. The development and use of these 24 character strengths has consistently demonstrated associations with well-being across the lifespan.
Strength-based Parenting Programs The content of strength-based parenting programs typically revolves around introducing parents to character strengths, helping parents to identify character strengths within themselves and their child, teaching parents to notice and encourage their child's use of strengths, and helping parents to employ their strengths within the caregiving role. Within the published literature, strength-based parenting programs have been delivered in two formats: in-person workshops and online handouts. These programs have demonstrated positive effects, including improving caregiving self-efficacy, positive emotions toward the child, and family well-being relative to waitlist control groups. However, the format of these programs may have limited the number of parents who could access and engage with the resources.
Access and Engagement It is important to consider the extent to which caregivers can access and engage with programs because access and engagement are necessary pre-requisites to program effectiveness. Research on parenting programs suggests that in-person workshops are not accessible to many families, particularly families of lower socio-economic status. Online handouts may be more accessible, but may struggle to engage families, as interactive, media-rich online materials tend to be more engaging. To address these concerns, O'Byrne et al (in press) developed an online strength-based parenting intervention for kindergarten-aged children, Strengths to Grow, designed to maximize accessibility and engagement by providing the program online using interactive rather than static materials.
An Online, Interactive, Strength-based Parenting Program for Preteens In a preliminary evaluation of the Strengths to Grow program, O'Byrne et al. (in press) found that parents reacted positively to the online, interactive format and the strength-based content. Additionally, within the sample, the program was accessible to families of lower socio-economic status who are difficult to access with in-person resources. While a more formal assessment of the effectiveness of Strengths to Grow is underway, preliminary findings suggest that the Strengths to Grow model may be effective at engaging hard-to-reach parents. However, the current Strengths to Grow program is designed specifically for parents of kindergarten to Grade 3 children. Because the strengths profiles and displays of kindergarten children may be different from other age groups, the current iteration of Strengths to Grow may not be generalizable to older children. Thus, the present research seeks to broaden the reach of Strengths to Grow by adapting it for parents of pre-adolescents (Grades 4 to 8; Strengths to Grow: Preteen). In addition, the present study will investigate 1. who is accessing Strengths to Grow: Preteen; 2. how Strengths to Grow: Preteen is being accessed; 3. whether participants report being satisfied with Strengths to Grow: Preteen; and 4. whether specific participant characteristics predict satisfaction with Strengths to Grow: Preteen.
- Conditions
- Mental Health Wellness 1
- Being tested
- Strengths to Grow: Preteen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengths to Grow: PreteenBehavioural
An online, strength based parenting program for parents of preteens (aged 9-14).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Strengths to Grow Program In an online, self-directed format, the Strengths to Grow: Preteen program will present the principles of strength-based parenting using videos, pictures, reflection questions, and written text. The intervention will communicate that a) every child has a unique set of strengths and that b) noticing and developing these strengths can enhance child and family well-being. It will also provide concrete steps that parents can follow to talk with their child about strengths, and it will provide ideas for family activities that would allow family members to express strengths. Participants will be invited to respond to reflection questions at various points throughout the program. Receives: Behavioral: Strengths to Grow: Preteen |
| Waitlist Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Sense of Competence Scale: Efficacy Subscale (Johnston & Mash, 1989)
Caregiving Self-Efficacy; 1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate increased sense of competence
Measured: 1 week
Modified Differential Emotions Scale (Fredrickson, 2013) [Instructions modified to capture child-oriented emotions consistent with Waters and Sun (2016)]
Parent child-Oriented Positive Emotions; 0 = Never to 4 = Most of the time; higher scores indicate increased positive emotions
Measured: 1 week
Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)
Parent happiness; 1 to 7 (various anchors); higher scores indicated increased happiness
Measured: 1 week
Patient Health Questionnaire 4 (Kroenke et al., 2009) [Instructions modified to capture parent's perceptions of child mental health]
Child mental health; 0 = Not at all to 4 = Nearly every day; higher scores indicate worse mental health
Measured: 1 week
Perceived Stress Scale (Cohen, 1994)
Parent stress; 0 = Never to 4 = Very often; higher scores indicate higher stress
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start3 Oct 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The current study is a two-wave randomized controlled trial that employs a 2 (group - between participants) by 2 (time - within participants) mixed measures design to assess a brief online strength-based parenting program.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Lumley, University of Guelph
- Investigators
- Margaret Lumley, PhD, CPsych, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582057
- Sponsor's protocol ID
- 21-08-001-2
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data as this has not been approved by our Research Ethics Board.
Publications
Friedmann, J. (2022). Assessing Character Strengths in Young Children (Doctoral dissertation, University of Guelph).
Danaher BG, Boles SM, Akers L, Gordon JS, Severson HH. Defining participant exposure measures in Web-based health behavior change programs. J Med Internet Res. 2006 Aug 30;8(3):e15. doi: 10.2196/jmir.8.3.e15.
PubMed 16954125Eisner M, Meidert U. Stages of parental engagement in a universal parent training program. J Prim Prev. 2011 Apr;32(2):83-93. doi: 10.1007/s10935-011-0238-8.
PubMed 21424399Fernandez MA, Eyberg SM. Predicting treatment and follow-up attrition in parent-child interaction therapy. J Abnorm Child Psychol. 2009 Apr;37(3):431-41. doi: 10.1007/s10802-008-9281-1.
PubMed 19096926Fredrickson, B. L. (2013). Chapter One-Positive Emotions Broaden and Build. In P. Devine & A. Plant (Eds.), Advances in Experimental Social Psychology (Vol. 47, pp. 1-53). Academic Press. https://doi.org/10.1016/B978-0-12-407236-7.00001-2
Ivtzan, I., Niemiec, R. M., & Briscoe, C. (2016). A study investigating the effects of Mindfulness-Based Strengths Practice (MBSP) on wellbeing. International Journal of Wellbeing, 6(2), 1- 13. https://doi.org/10/gfscgj
Jach, H. K., Sun, J., Loton, D., Chin, T.-C., & Waters, L. (2018). Strengths and subjective wellbeing in adolescence: Strengthbased parenting and the moderating effect of mindset. Journal of Happiness Studies, 19(2), 567-586. https://doi.org/10/gfscg9
Johnston, C., & Mash, E. J. (1989). A Measure of Parenting Satisfaction and Efficacy. Journal of Clinical Child Psychology, 18(2), 167-175. https://doi.org/10.1207/s15374424jccp1802_8
Kazdin, A. E., & Rabbitt, S. M. (2013). Novel models for delivering mental health services and reducing the burdens of mental illness. Clinical Psychological Science, 1(2), 170-191. https://doi.org/10/gc4pnm
Lavigne JV, Lebailly SA, Gouze KR, Binns HJ, Keller J, Pate L. Predictors and correlates of completing behavioral parent training for the treatment of oppositional defiant disorder in pediatric primary care. Behav Ther. 2010 Jun;41(2):198-211. doi: 10.1016/j.beth.2009.02.006. Epub 2009 Dec 5.
PubMed 20412885Lyubomirsky, S., & Lepper, H. S. (1999). A Measure of Subjective Happiness: Preliminary Reliability and Construct Validation. Social Indicators Research, 46(2), 137-155. https://doi.org/10.1023/A:1006824100041
McGoron L, Hvizdos E, Bocknek EL, Montgomery E, Ondersma SJ. Feasibility of Internet-based Parent Training for Low-income Parents of Young Children. Child Youth Serv Rev. 2018 Jan;84:198-205. doi: 10.1016/j.childyouth.2017.12.004. Epub 2017 Dec 5.
PubMed 29731531O'Byrne R, Thompson R, Friedmann JS, Lumley MN. Parent Engagement with an Online, School-Based, Character Strengths Promotion Program. Int J Appl Posit Psychol. 2022;7(3):355-377. doi: 10.1007/s41042-022-00072-4. Epub 2022 Aug 11.
PubMed 35971433Peterson, C., & Seligman, M. E. P. (2004). Introduction to a manual of the sanities. In Character strengths and virtues (pp.18-104). American Psychological Association; Oxford University Press. https://books.scholarsportal.info/uri/ebooks/ebooks0/oxford/2009- 11-30/3/0195167015
Ritterband, L. M., Cox, D. J., Gordon, T. L., Borowitz, S. M., Kovatchev, B. P., Walker, L. S., & Sutphen, J. L. (2006). Examining the Added Value of Audio, Graphics, and Interactivity in an Internet Intervention for Pediatric Encopresis. Children's Health Care, 35(1), 47-59. https://doi.org/10.1207/s15326888chc3501_5
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengths to Grow Preteen: An Online Parenting Resource
- ClinicalTrials.gov ID
- NCT05582057
- Acronym / sponsor ID
- 21-08-001-2
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research suggests that strength-based parenting programs can enhance family well-being, but the current formats of these programs (e.g., in-person workshops) are not accessible to many families. The first aim of the study is to adapt Strengths to Grow, an accessible and engaging strength-based parenting program, for pre-teens. The second aim of the study is to assess the effectiveness this adapted program (Strengths to Grow: Preteen). Toward this end, parents of children in Grades 4 through 8 will be invited to complete a brief, online survey of well-being before and a few weeks after completing the online program to assess its impact on well-being.
Detailed description
Strength-based Parenting Strength-based parenting is a style of caregiving which identifies and cultivates strengths in the child and caregiver. When parents employ a strength-based parenting style, youth tend to demonstrate greater academic achievement, resilience, and overall well-being, and parents tend to experience more well-being within the caregiving role. Additionally, it is believed that caregivers can develop a strength-based parenting style through training and practice. For these reasons, several strength-based parenting programs have been developed.
Character Strengths Strength-based parenting programs typically focus on helping parents to identify and develop a particular type of strength known as character strengths. Character strengths are personal qualities that are widely regarded as morally good (e.g., bravery, curiosity, kindness). In 2004, Peterson and Seligman completed a comprehensive review that identified 24 character strengths. The development and use of these 24 character strengths has consistently demonstrated associations with well-being across the lifespan.
Strength-based Parenting Programs The content of strength-based parenting programs typically revolves around introducing parents to character strengths, helping parents to identify character strengths within themselves and their child, teaching parents to notice and encourage their child's use of strengths, and helping parents to employ their strengths within the caregiving role. Within the published literature, strength-based parenting programs have been delivered in two formats: in-person workshops and online handouts. These programs have demonstrated positive effects, including improving caregiving self-efficacy, positive emotions toward the child, and family well-being relative to waitlist control groups. However, the format of these programs may have limited the number of parents who could access and engage with the resources.
Access and Engagement It is important to consider the extent to which caregivers can access and engage with programs because access and engagement are necessary pre-requisites to program effectiveness. Research on parenting programs suggests that in-person workshops are not accessible to many families, particularly families of lower socio-economic status. Online handouts may be more accessible, but may struggle to engage families, as interactive, media-rich online materials tend to be more engaging. To address these concerns, O'Byrne et al (in press) developed an online strength-based parenting intervention for kindergarten-aged children, Strengths to Grow, designed to maximize accessibility and engagement by providing the program online using interactive rather than static materials.
An Online, Interactive, Strength-based Parenting Program for Preteens In a preliminary evaluation of the Strengths to Grow program, O'Byrne et al. (in press) found that parents reacted positively to the online, interactive format and the strength-based content. Additionally, within the sample, the program was accessible to families of lower socio-economic status who are difficult to access with in-person resources. While a more formal assessment of the effectiveness of Strengths to Grow is underway, preliminary findings suggest that the Strengths to Grow model may be effective at engaging hard-to-reach parents. However, the current Strengths to Grow program is designed specifically for parents of kindergarten to Grade 3 children. Because the strengths profiles and displays of kindergarten children may be different from other age groups, the current iteration of Strengths to Grow may not be generalizable to older children. Thus, the present research seeks to broaden the reach of Strengths to Grow by adapting it for parents of pre-adolescents (Grades 4 to 8; Strengths to Grow: Preteen). In addition, the present study will investigate 1. who is accessing Strengths to Grow: Preteen; 2. how Strengths to Grow: Preteen is being accessed; 3. whether participants report being satisfied with Strengths to Grow: Preteen; and 4. whether specific participant characteristics predict satisfaction with Strengths to Grow: Preteen.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The current study is a two-wave randomized controlled trial that employs a 2 (group - between participants) by 2 (time - within participants) mixed measures design to assess a brief online strength-based parenting program.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Strengths to Grow: PreteenBehavioral: Strengths to Grow Program In an online, self-directed format, the Strengths to Grow: Preteen program will present the principles of strength-based parenting using videos, pictures, reflection questions, and written text. The intervention will communicate that a) every child has a unique set of strengths and that b) noticing and developing these strengths can enhance child and family well-being. It will also provide concrete steps that parents can follow to talk with their child about strengths, and it will provide ideas for family activities that would allow family members to express strengths. Participants will be invited to respond to reflection questions at various points throughout the program. |
| Waitlist Control Group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parent of a child(ren) who is enrolled in Grade 4 to 8 at the Upper Grand District School Board in Guelph, Ontario
- Able to read and write in English (linguistic proficiency equivalent to a Grade 8 reading level or greater)
- Consent to participate in the research study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengths to Grow: PreteenAn online, strength based parenting program for parents of preteens (aged 9-14). | Behavioural | Experimental Group |
Primary outcome
Parenting Sense of Competence Scale: Efficacy Subscale (Johnston & Mash, 1989)
Time frame: 1 week
Caregiving Self-Efficacy; 1 = Strongly Disagree to 6 = Strongly Agree; higher scores indicate increased sense of competence
Modified Differential Emotions Scale (Fredrickson, 2013) [Instructions modified to capture child-oriented emotions consistent with Waters and Sun (2016)]
Time frame: 1 week
Parent child-Oriented Positive Emotions; 0 = Never to 4 = Most of the time; higher scores indicate increased positive emotions
Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)
Time frame: 1 week
Parent happiness; 1 to 7 (various anchors); higher scores indicated increased happiness
Patient Health Questionnaire 4 (Kroenke et al., 2009) [Instructions modified to capture parent's perceptions of child mental health]
Time frame: 1 week
Child mental health; 0 = Not at all to 4 = Nearly every day; higher scores indicate worse mental health
Perceived Stress Scale (Cohen, 1994)
Time frame: 1 week
Parent stress; 0 = Never to 4 = Very often; higher scores indicate higher stress
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- BackgroundFriedmann, J. (2022). Assessing Character Strengths in Young Children (Doctoral dissertation, University of Guelph).
- Background: PubMed 16954125Danaher BG, Boles SM, Akers L, Gordon JS, Severson HH. Defining participant exposure measures in Web-based health behavior change programs. J Med Internet Res. 2006 Aug 30;8(3):e15. doi: 10.2196/jmir.8.3.e15.
- Background: PubMed 21424399Eisner M, Meidert U. Stages of parental engagement in a universal parent training program. J Prim Prev. 2011 Apr;32(2):83-93. doi: 10.1007/s10935-011-0238-8.
- Background: PubMed 19096926Fernandez MA, Eyberg SM. Predicting treatment and follow-up attrition in parent-child interaction therapy. J Abnorm Child Psychol. 2009 Apr;37(3):431-41. doi: 10.1007/s10802-008-9281-1.
- BackgroundFredrickson, B. L. (2013). Chapter One-Positive Emotions Broaden and Build. In P. Devine & A. Plant (Eds.), Advances in Experimental Social Psychology (Vol. 47, pp. 1-53). Academic Press. https://doi.org/10.1016/B978-0-12-407236-7.00001-2
- BackgroundIvtzan, I., Niemiec, R. M., & Briscoe, C. (2016). A study investigating the effects of Mindfulness-Based Strengths Practice (MBSP) on wellbeing. International Journal of Wellbeing, 6(2), 1- 13. https://doi.org/10/gfscgj
- BackgroundJach, H. K., Sun, J., Loton, D., Chin, T.-C., & Waters, L. (2018). Strengths and subjective wellbeing in adolescence: Strengthbased parenting and the moderating effect of mindset. Journal of Happiness Studies, 19(2), 567-586. https://doi.org/10/gfscg9
- BackgroundJohnston, C., & Mash, E. J. (1989). A Measure of Parenting Satisfaction and Efficacy. Journal of Clinical Child Psychology, 18(2), 167-175. https://doi.org/10.1207/s15374424jccp1802_8
- BackgroundKazdin, A. E., & Rabbitt, S. M. (2013). Novel models for delivering mental health services and reducing the burdens of mental illness. Clinical Psychological Science, 1(2), 170-191. https://doi.org/10/gc4pnm
- Background: PubMed 20412885Lavigne JV, Lebailly SA, Gouze KR, Binns HJ, Keller J, Pate L. Predictors and correlates of completing behavioral parent training for the treatment of oppositional defiant disorder in pediatric primary care. Behav Ther. 2010 Jun;41(2):198-211. doi: 10.1016/j.beth.2009.02.006. Epub 2009 Dec 5.
- BackgroundLyubomirsky, S., & Lepper, H. S. (1999). A Measure of Subjective Happiness: Preliminary Reliability and Construct Validation. Social Indicators Research, 46(2), 137-155. https://doi.org/10.1023/A:1006824100041
- Background: PubMed 29731531McGoron L, Hvizdos E, Bocknek EL, Montgomery E, Ondersma SJ. Feasibility of Internet-based Parent Training for Low-income Parents of Young Children. Child Youth Serv Rev. 2018 Jan;84:198-205. doi: 10.1016/j.childyouth.2017.12.004. Epub 2017 Dec 5.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data as this has not been approved by our Research Ethics Board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Lumley, PhD, CPsych principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengths to Grow: Preteen in people with Mental Health Wellness 1, run by University of Guelph at 1 site in Canada.
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 0 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 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Margaret Lumley, PhD, CPsych (519-824-4120 ext. 56798, mlumley@uoguelph.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Sense of Competence Scale: Efficacy Subscale (Johnston & Mash, 1989) (time frame: 1 week). The study lists 5 primary outcomes in all. 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 NCT05582057, which also lists 21 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 Nov 2022.