Depression, AnxietyPM+MiLENCT06601023
Problem Management Plus Mindfulness-informed Legal Education for Addressing Gender-based Violence and Improving Parenting
A study testing Psychosocial intervention in people with Depression, Anxiety and Trauma, run by Teesside University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Trauma, Anxiety
- What is being tested?
- Psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 24 Sep 2024to 30 Jun 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and above
- Female with child(ren) or with caring responsibilities for child(ren).
- Able to provide full consent for their participation.
- A resident of the study areas (Delta, Jos, Lagos State, etc.)
Who cannot join
- Less than 18 years
- Unable to consent
- Currently undergoing severe mental healthtreatment
- Unable to speak the English language fl uently
Trial locations and contacts
No sites are listed yet.
Dung E Jidong, Dr contact
About this study
Official title: Problem Management Plus Mindfulness-informed LegalEducation (PM+MiLE) for Addressing Gender-based Violence and Improving Parenting in Nigeria: a Randomised Control Trial
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.
- Conditions
- Depression, Anxiety, Trauma, Anxiety, Parenting Intervention, Woman Abuse, Child Behaviour
- Being tested
- Psychosocial intervention
- Keywords
- Depression, Stress, Anxiety, Trauma, Gender-based violence, Parenting, Domestic violence, Women
- Medical subject headings
- Depression, Anxiety Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Problem Management plus Mindfulness-informed LegalEducation (PM+MiLE) | Experimental | The PM+MiLE is a six sessions intervention lasting approximately 90 minutes. A session will be delivered weekly for six week. Receives: Behavioral: Psychosocial intervention |
| Control - Waitlist Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks at the end of intervention
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 6 weeks end of intervention and 3 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Sep 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- Jos University Teaching Hospital, University of Manchester
- Responsible party
- Principal investigator, Tarela Ike, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601023
- Sponsor's protocol ID
- 0000-0003-0516-0313e
- Other IDs
- PM+MiLE
- Acronym
- PM+MiLE
- Status last verified
- Aug 2024
- First submitted
- 14 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
Publications
Oladepo O, Yusuf OB, Arulogun OS. Factors influencing gender based violence among men and women in selected states in Nigeria. Afr J Reprod Health. 2011 Dec;15(4):78-86.
PubMed 22571109Aborisade, R.A., (2024). Violence In A Patriarchal Nigerian Society. Routledge International Handbook of Investigative Interviewing and Interrogation, p.372.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem Management Plus Mindfulness-informed LegalEducation (PM+MiLE) for Addressing Gender-based Violence and Improving Parenting in Nigeria: a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06601023
- Acronym / sponsor ID
- PM+MiLE / 0000-0003-0516-0313e
- Conditions
- Depression, Anxiety, Trauma, Anxiety, Parenting Intervention, Woman Abuse, Child Behaviour
- Keywords
- Depression, Stress, Anxiety, Trauma, Gender-based violence, Parenting, Domestic violence, Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- Jos University Teaching Hospital, University of Manchester
- Study start
- 24 Sep 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem Management plus Mindfulness-informed LegalEducation (PM+MiLE) | Experimental | Behavioral: Psychosocial interventionThe PM+MiLE is a six sessions intervention lasting approximately 90 minutes. A session will be delivered weekly for six week. |
| Control - Waitlist Group | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and above
- Female with child(ren) or with caring responsibilities for child(ren).
- Able to provide full consent for their participation.
- A resident of the study areas (Delta, Jos, Lagos State, etc.)
Key exclusion criteria (4 listed)
- Less than 18 years
- Unable to consent
- Currently undergoing severe mental healthtreatment
- Unable to speak the English language fl uently
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 |
|---|---|---|
| Psychosocial interventionThe 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. | Behavioural | Problem Management plus Mindfulness-informed LegalEducation (PM+MiLE) |
Primary outcome
Service Satisfaction Scale
Time frame: 6 weeks at the end of intervention
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.
9 secondary outcomes
Gender-based Violence, Stress and Parenting Scale
Time frame: Baseline, end of intervention and 3 months post intervention.
Post-traumatic Stress Disorder Checklist (PCL-5)
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Generalised Anxiety Disorder (GAD-7)
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Oslo Social Support Scale (OSSS-3)
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Legal-informed Awareness of Complaint Channel Scale (LACCS)
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Harsh Parenting Scale
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Parenting Stress Scale
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
European Quality of Life Scale EQ-5D-5L
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 6 weeks end of intervention and 3 months post intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 22571109Oladepo O, Yusuf OB, Arulogun OS. Factors influencing gender based violence among men and women in selected states in Nigeria. Afr J Reprod Health. 2011 Dec;15(4):78-86.
- BackgroundAborisade, R.A., (2024). Violence In A Patriarchal Nigerian Society. Routledge International Handbook of Investigative Interviewing and Interrogation, p.372.
- Individual participant dataSharing planned: No. Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
Related trials for Depression, Anxiety
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Dung E Jidong, Dr contact
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial intervention in people with Depression, Anxiety and Trauma, run by Teesside 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 4 inclusion and 4 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 19 Sep 2024. 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 Tarela J. Ike, Dr (016-423-4231, T.Ike@tees.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Service Satisfaction Scale (time frame: 6 weeks at the end of intervention). 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 NCT06601023, which also lists 2 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 19 Sep 2024.