An interventional study of Psychosocial intervention in Depression, Anxiety, Trauma and Anxiety, sponsored by Teesside University. Not yet recruiting. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Teesside University · Not applicable, Interventional, and Treatment
Gender-based violence and, more specifically, domestic violence is a prevalent problem globally and in Nigeria. Its effect significantly impacts women and also the wellbeing of their families. Limited access to support has posed a constraint in effectively addressing the issues suffered by affected victims in Nigeria. In addition, gender-based violence could affect parenting due to factors such as anxiety, trauma, depression, poor social support, limited awareness of legal channels for complaint and harsh parenting to children. The implication is that it could not only have a negative impact on the affected victim but also on their parenting styles or caring responsibilities, which could be detrimental to the child development, wellbeing and the potential subsequent resort to criminal behaviours. In essence, the current study aims to test the feasibility and acceptability of a novel cross disciplinary intervention titled, Problem Management plus Mindfulness-informed Legal Education (PM+MiLE) for addressing gender-based violence and improving parenting in Nigeria in comparison to the waitlist control group for the purposes of improving social cohesion, legal awareness, wellbeing and reducing depression, including trauma and anxiety as a result of experiencing gender-based violence, in Nigeria.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 24 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Teesside University is the lead sponsor of 55 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
The PM+MiLE is a six sessions intervention lasting approximately 90 minutes. A session will be delivered weekly for six week.
Behavioral: Psychosocial intervention
The control group will receive no intervention until after the assessment periods at baseline, end of intervention and 3 months follow up before they will be administered the PM+MiLE.
The PM+MiLE is a low-intensity intervention. The intervention will cover relevant aspects of brief mindfulness, legal education, awareness of human rights and challenges of complaint, including support. The problem management ambit will include understanding adversity, managing stress, managing problems, getting going and keep doing, strengthening social support and staying well and looking forward, including positive behaviour modification.The intervention will also incorporate child development and building positive parenting interactions with children.
Service Satisfaction Scale
A five item scale that can be used to assess and measure satisfaction, acceptability and quality of the intervention. Higher score denote positive outcomes and acceptability. Lower score denotes poor satisfaction and acceptability.
Time frame: 6 weeks at the end of intervention
Gender-based Violence, Stress and Parenting Scale
The scale is a 4 item scale that will be use for assessing and measuring gender-based violence, stress and parenting. The scale has an overall rating of 20 with score ranging 1-5 indicating severe stress in parenting, 5-10 indicating moderately severe stress in parenting, 11-15 mild stress in parenting and 16- 20 no stress in parenting.
Time frame: Baseline, end of intervention and 3 months post intervention.
Post-traumatic Stress Disorder Checklist (PCL-5)
The PCL-5 is a 20-item self-report measure that can be used to assess the 20 DSM-5 symptoms of post traumatic stress disorder. A 5-10 point change represents reliable change (i.e., change not due to chance) and a 10-20 point change represents clinically significant change.
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Generalised Anxiety Disorder (GAD-7)
The GAD-7 is a seven item scale for screening, measuring and assessing the severity of generalised anxiety disorder. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Oslo Social Support Scale (OSSS-3)
The scale is a 3-item self-reported measure designed for assessing and measuring the level of social support. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support as indicated as follows: a) 3-8 poor social support, b) 9-11 moderate social support, c) 12-14 strong social support.
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Legal-informed Awareness of Complaint Channel Scale (LACCS)
The LACCS is a 10-item scale that is designed for assessing and measuring level of awareness of complaint channels and legal rights. The scale has an overall rating of 30, with 0-7 indicating poor knowledge, 8-15 (average knowledge), 16-22 (good knowledge) and 23-30 (excellent knowledge).
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Harsh Parenting Scale
The scale is a 4 item scale use to assess harsh parenting. The scale has a rating of 20 with lower scores indicating non harsh parenting and higher scores indicating severe harsh parenting.
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Parenting Stress Scale
The PSS is an 18-item questionnaire for assessing parents' feelings about their parenting role, exploring both positive aspects (e.g. personal development, emotional benefits,) and negative aspects of parenthood (e.g. demands on resources, and feelings of stress). Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
European Quality of Life Scale EQ-5D-5L
The EQ-5D-5L is a 5 item scale designed to aid assessment of the generic quality of life. In the EQ-5D-5L, each dimension has five response levels: no problems (Level 1); slight (Level 2); moderate (Level 3); severe (Level 4); and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Patient Health Questionnaire (PHQ-9)
This The Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that will be used for screening, monitoring, measuring and assessing the severity of depression. Low scores (e.g. 0-4) indicate no depression, however, higher scores (20-27) indicates severe depression.
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
No study locations are listed for this record.
Plan to share: No — Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
Start is estimated for Sep 2024; primary completion for May 2025, 8 months later.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 8 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Teesside University