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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05229146
Other study ID # NHP: 15407-31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2022
Est. completion date November 21, 2023

Study information

Verified date January 2024
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Parents of children from impoverished communities are disproportionately more likely to engage in harsh physical discipline, which can lead to serious clinical outcomes, including suicidal ideation and attempts. One mechanism linking low resource environments and maladaptive parenting strategies is maternal delay discounting, or the tendency to value smaller, immediate rewards (such as stopping children's misbehavior via physical means) relative to larger, but delayed rewards (like improving the parent-child relationship). This study will examine the efficacy of implementing a low-cost, brief intervention targeting the reduction of maternal delay discounting to inform broader public health efforts aimed at improving adolescent mental health outcomes in traditionally underserved communities.


Description:

Harsh parenting is associated with serious and costly mental health problems among youth, including substance use, mood disorders, and suicidal ideation and behaviors. Of concern, these parenting practices are most common among families from impoverished communities; however, many behaviorally-based parenting interventions do not take into account the unique mechanisms linking environmental disadvantage to parenting approaches. While the causes of harsh parenting are complex and varied, one such mechanism may be parents' tendencies to prioritize immediate rewards (such as stopping a child's misbehavior via physical punishment like spanking and hitting) relative to larger, but delayed rewards (including improved parent-child relationship quality), known as delay discounting. This case series will examine the efficacy of episodic future thinking (EFT) to target reduction of parenting-related delay discounting. Outcomes will evaluate the effect of EFT on reducing maternal delay discounting and harsh parenting, and improving child clinical outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date November 21, 2023
Est. primary completion date November 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: 1. Be the mother from the Flint area of a child between the ages of 5-10 who can provide legal consent for that child to participate in this study 2. Self-report that the child lives with them for at least 50% of the time 3. Willing to participate in the study 4. Able to participate in written assessments and an intervention conducted in English 5. Have a working cell phone that can receive and send text messages and be willing to receive/send text messages as part of the study 6. Have a phone or device that's able to use video conferencing software Exclusion Criteria: 1. Self-disclosed active suicidality/homicidality 2. Self-disclosed current bipolar disorder, schizophrenia, or psychosis 3. Current and ongoing involvement with child protective services

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Episodic Future Thinking
Episodic future thinking (EFT) includes a focus on generating detailed and vivid descriptions of future events. For the current intervention, EFT will be modified to have mothers describe specific events with their children.

Locations

Country Name City State
United States RL Jones Community Outreach Center Flint Michigan

Sponsors (4)

Lead Sponsor Collaborator
Henry Ford Health System Michigan State University, University of Kansas, University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Monetary Choice Questionnaire The Monetary Choice Questionnaire (MCQ) is a 27-item binary-choice task, which asks participants to select between two hypothetical monetary amounts: a smaller reward available immediately (e.g. $49 today) or a larger reward available after a delay (e.g. $60 in 89 days). The measure is scored to derive a discounting rate k, with larger values reflecting more problematic rates of discounting. Because k distributions are typically skewed, post-hoc natural logarithmic transformations will be performed, which have been shown to approximate normal distributions. The MCQ has been shown to have strong psychometric properties among adults and correlates with real rewards, as well as real-world risk behaviors. Baseline, 1 week, 4 weeks
Primary Change in Consideration of Future Consequences Scale Score The Consideration of Future Consequences Scale1 (CFCS-14) is a 14-item self-report questionnaire that assesses active consideration of longer-term implications of an individual's actions. Lower scores on the CFCS-14 are associated with a greater focus on immediate needs and have been found to be associated with less engagement in health behaviors1819 and greater substance use. The measure has been used extensively among adult samples and demonstrates strong reliability and validity. Research suggests modest but significant correlations with the MCQ. Change in CFCS-14 score is measured by comparing scores at the post-intervention assessment (approximately 4 weeks after baseline) with baseline scores. Baseline, 4 weeks
Secondary Change in Dyadic Parent-Child Interaction Coding System Scores Parents and their children will complete a 20-minute interaction task, including five minutes of free play, a ten minute "homework" task in which children are given a math worksheet and parents are told to provide help "as you see fit," and a five minute clean up task. Interactions will be video recorded and coded using the Dyadic Parent-Child Interaction Coding System (DPICS) which yields to composite scores: positive parenting (including praise, positive affect, and physical positive interactions) and negative parenting (including negative commands, critical statements, and physical negative interactions). Change in positive parenting and negative parenting scores will be calculated by comparing baseline scores with scores at the post-intervention sessions (approximately 4 weeks after baseline) Baseline, 4 weeks
Secondary Change in Alabama Parenting Questionnaire Score The Alabama Parenting Questionnaire (APQ) is a 42-item self-report measure of parenting behaviors. Change in APQ scores will be measured by comparing post-intervention scores (approximately 4 weeks after baseline) with baseline scores. Baseline, 4 weeks
Secondary Change in Emotion Regulation Checklist Parents will report on children's emotion regulation using the Emotion Regulation Checklist (ECR). The ECR includes 24 items that yield two subscales: (1) lability/negativity and (2) emotion regulation. The measure is widely used and validated for parent-report of older children and young adolescents. Baseline, 4 weeks
Secondary Client Satisfaction Questionnaire - 8 Following the completion of the intervention, mothers will complete the Client Satisfaction Questionnaire - 8 (CSQ-8), which evaluates participant satisfaction with the sessions. The measure is used across a number of intervention studies and has been shown to be reliable and valid in adult samples. Baseline, 4 weeks
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