Jerash Camp
Jerash, Jordan
Location status: Recruiting
NCT Number: NCT07494786
The primary aim of this research is to evaluate if ParentText for Crisis helps improve the following outcomes among Palestinian caregivers living in Jordan: a.) Improving caregiver mental health; b.) Improving positive parenting practices; c.) Reducing violence against children
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Jerash, Jordan
Location status: Recruiting
This individually randomised controlled trial (RCT) is an evaluation of Palestinian ParentText for Crisis in Jordan, a rule-based chatbot to provide tips to strengthen parental mental health, improve parenting practices, and help parents support children in crisis settings. This randomised controlled trial is conducted through a collaboration with the University of Oxford, Parenting for Lifelong Health (PLH), and Sanadak. ParentText for Crisis content is adapted from PLH and "Hope Groups", which is a mental health and parenting programme originally developed from PLH for war and crisis settings. Hope Groups, delivered either in-person, have demonstrated effectiveness in improving caregiver mental health and parenting practices in crisis settings among Palestinians in Jerash Camp, Jordan. This study aims to evaluate the effectiveness of delivering this mental health and parenting content via 9 chatbot-delivered lessons over WhatsApp to Palestinian families within the same camp (Jerash Camp, Jordan). The RCT includes an intervention arm consisting of individuals who are randomised to join CrisisText immediately, and a waitlist control arm consisting of individuals who are randomised to join CrisisText after the intervention arm. This is an individually randomised study, with each individual participant as the unit of randomisation, and randomisation deployed using the treatment_assign function in the RCT package in R. The first cohort aimed to include N=240 Palestinian participants (N=120 randomised to intervention and N=120 randomised to control). As data collection for the first cohort completed, additional funding was secured to include a second cohort of another N=240 Palestinian participants (N=120 randomised to intervention and N=120 randomised to control). Thus, this RCT will roll out over two cohorts, conducted as two back-to-back RCTs, following procedures from staircase trials, cumulative trials, and adaptive trials. A Bayesian interim analysis will be conducted after the first cohort of N=240 participants to inform the trial's second cohort. The interim analysis will inform whether a) if harmful effects are identified, all activity will be paused; b) if the intervention demonstrates promise for statistical and clinical significance, the trial will continue into a second cohort; c) if the intervention does not demonstrate promise for statistical and clinical significance, the intervention will be enhanced prior to the second cohort. All details for the interim analysis are included in the posted statistical analysis plan.
Overall, the primary aim of this RCT is to test the effectiveness of ParentText for Crisis 30-days after enrolment, using an individually randomised controlled trial design. The final analysis will be conducted after the completion of the second cohort. Investigators hypothesise that ParentText for Crisis will lead to statistically significant improvements in caregiver mental health and positive parenting practices, and reductions in violence against children.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Sanadak, a charity in Jordan, will collaborate with the camp to recruit a list of 250 participants. All N=250 individuals, who indicate interested in participating, will be randomised to the intervention or wait-list control arm.
A rule-based chatbot to provide tips to strengthen parental mental health, improve parenting practices, and help parents support children in crisis settings
Time frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
Caregiver depression is measured via Patient Health Questionnaire - 2 (PHQ-2). PHQ-2 includes two questions on depression, with likert scale answer options ranging 0-3. Higher scores indicate higher levels of depression.
Time frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
Parenting Practices are measured via a positive parenting item adapted from Alabama Parenting Questionnaire, measuring frequency of playing with children in the past week. Survey responses are reported in days of occurrence within the past week (0-7), with higher scores indicating higher level of playful parenting.
Time frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
Caregiver Hopefulness is measured through an item building on positive psychology theory, asking, "How many days in the past week did you feel hopeful about the future?" Answer options range from 0-7 to reflect days of occurrence in the past week. Higher scores indicate high levels of hopefulness.
Time frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
Parenting Practices are measured through a parental involvement question adapted from Alabama Parenting Questionnaire and a Parental Supervision question adapted from Alabama Parenting Questionnaire. Answer options for both questions are reported in days of occurrence in the past week (0-7), with higher scores indicating higher levels of positive parenting practices.
Time frame: Intervention arm: Outcome is collected at trial baseline and +30 days post-baseline. Control arm: Outcome is collected at +30 days post-baseline.
Violence Against Children is measured via 2 questions on physical and emotional violence actions from the ISPCAN Child Abuse Screening Tool for Trials (ICAST-Trial). Questions ask about frequency of occurrence in days in the past week, with answer options range from 0-7. Higher scores indicate higher frequency of violence against children.
Contact information is provided by the study sponsor or research team.
University of Oxford
Other
ParentText for Crisis: A Randomised Controlled Trial of Chatbot-Delivered Mental Health and Parenting Content For Palestinian Caregivers in Jordan
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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