Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05229120
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2022-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Improving Delay Discounting to Decrease Harsh Parenting Among Parents Receiving Substance Use Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jfelton4@hfhs.org', 'phone': '704-995-7832', 'title': 'Julia Felton, PhD', 'organization': 'Henry Ford Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were involved in the study for approximately four weeks from consent to follow-up period.', 'eventGroups': [{'id': 'EG000', 'title': 'Episodic Future Thinking', 'description': 'Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic future thinking focused condition. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention, focused on generating future, pleasant events with their children. After the intervention session, parents will receive a daily postcard over the course of two weeks including a reminder cue generated as part of the episodic future thinking (EFT) intervention and a prompt to remember these episodes in vivid detail.\n\nEpisodic Future Thinking: The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in the future with their children.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Delay Discounting 5 Trial Adjusted Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Episodic Future Thinking', 'description': 'Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic future thinking focused condition. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention, focused on generating future, pleasant events with their children. After the intervention session, parents will receive a daily postcard over the course of two weeks including a reminder cue generated as part of the episodic future thinking (EFT) intervention and a prompt to remember these episodes in vivid detail.\n\nEpisodic Future Thinking: The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in the future with their children.'}], 'classes': [{'title': 'Delay discounting (k-value) at baseline', 'categories': [{'measurements': [{'value': '-3.87', 'spread': '3.81', 'groupId': 'OG000'}]}]}, {'title': 'Delay discounting (k-value) at follow-up', 'categories': [{'measurements': [{'value': '-5.03', 'spread': '2.38', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.124', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'paramValue': '1.24', 'groupDescription': 'A single-sided paired-samples t-test comparing k-values at baseline to k-values at follow-up (approximately 4 weeks after baseline assessment) was examined. Given that k-values are typically skewed (and to be consistent with the existing literature) we used a log-k as our outcome variable.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'No adjustments were made. DF = 10.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The 5-Trial Adjusting Delay (Temporal Discounting) Task is a computer based system which uses an adjusting algorithm to determine the amount of immediately available money that is equivalent to a large sum that is delayed by seven discrete durations of time presented in a randomized order (i.e., 1 day, 1 week, 1 month, 6 months, 1 year, 5 years, and 25 years). The length of delay is titrated based on participants\' responses to previous items to determine an "indifference point" (the point at which the sums of money are perceived as equal). This is then converted to a k-value and logarithmically transformed to ensure the values are normally distributed, making them unbounded by min and max values. Higher k-values indicate a greater preference for immediate rewards. Change in Delay Discounting is evaluated by comparing baseline k-value scores with scores at the intervention (approximately 1 week after baseline) and the post-intervention assessment (approximately 4 weeks after baseline).', 'unitOfMeasure': 'log (k)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in analyses were those who completed the measure at both baseline and 4 weeks post.'}, {'type': 'PRIMARY', 'title': 'Change in Consideration of Future Consequences Scale - Parenting Adapted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Episodic Future Thinking', 'description': 'Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic future thinking focused condition. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention, focused on generating future, pleasant events with their children. After the intervention session, parents will receive a daily postcard over the course of two weeks including a reminder cue generated as part of the episodic future thinking (EFT) intervention and a prompt to remember these episodes in vivid detail.\n\nEpisodic Future Thinking: The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in the future with their children.'}], 'classes': [{'title': 'CFCS-14-PA Total Score at Baseline', 'categories': [{'measurements': [{'value': '54.93', 'spread': '6.08', 'groupId': 'OG000'}]}]}, {'title': 'CFCS-14-PA Total Score at Follow-Up', 'categories': [{'measurements': [{'value': '53.80', 'spread': '7.82', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.219', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.13', 'groupDescription': 'Changes in consideration of future consequences (parenting) was evaluated using one-sided paired samples t-tests.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'No adjustments were made. DF = 14.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'The Consideration of Future Consequences Scale-Parenting Adapted (CFCS-14-PA) is a 14-item self-report questionnaire composed of two subscales reflecting either immediate or future orientation related to parents interactions with their children. Items range from "not at all like me" (1) to "very much like me" (5) and are summed to create a total score with higher values reflecting greater future orientation. Scores range from 14 to 70. Change in CFCS-14-PA score is measured by comparing scores at the post-intervention assessment (approximately 4 weeks after baseline) with baseline scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All parent participants who completed baseline and follow-up assessments.'}, {'type': 'SECONDARY', 'title': 'Change in Dyadic Parent-Child Interaction Coding System Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Episodic Future Thinking', 'description': 'Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic future thinking focused condition. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention, focused on generating future, pleasant events with their children. After the intervention session, parents will receive a daily postcard over the course of two weeks including a reminder cue generated as part of the episodic future thinking (EFT) intervention and a prompt to remember these episodes in vivid detail.\n\nEpisodic Future Thinking: The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in the future with their children.'}], 'classes': [{'title': 'Positive Parenting Composite at Baseline', 'categories': [{'measurements': [{'value': '4.83', 'spread': '2.48', 'groupId': 'OG000'}]}]}, {'title': 'Negative Parenting at Baseline', 'categories': [{'measurements': [{'value': '3.17', 'spread': '4.07', 'groupId': 'OG000'}]}]}, {'title': 'Positive Parenting Composite at Follow-Up', 'categories': [{'measurements': [{'value': '4.83', 'spread': '3.60', 'groupId': 'OG000'}]}]}, {'title': 'Negative Parenting at Follow-Up', 'categories': [{'measurements': [{'value': '5.17', 'spread': '1.94', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.50', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.00', 'groupDescription': 'Performed a one-sided paired samples t-test examining changes in both positive parenting.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'No adjustments were made. DF = 5'}, {'pValue': '.187', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.0', 'groupDescription': 'Used a one-sided paired samples t-test to examine changes in negative parenting.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Parents and their children will complete a 20-minute interaction task, including 5 min. of free play, a 10 min. "homework" task, and a 5 min. clean up task. Interactions are recorded and coded using the Dyadic Parent-Child Interaction Coding System (DPICS), measuring the quality of parent and child interactions. The task is coded for 7 subscales, yielding 2 composite scores: positive parenting (a sum of: unlabeled praise, labeled praise, positive touch, reflection, and behavior description) and negative parenting (a sum of: negative talk and negative touch). Each instance of a behaviors described in the subscale (e.g., a parent giving unlabeled praise) is coded as one "point," which are summed into a subscale (no max or min values). Higher values indicate greater positive or negative parenting. 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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses included 6 parent-child dyads who completed both the pre- and post-intervention parent-child interaction task.'}, {'type': 'SECONDARY', 'title': 'Change in Alabama Parenting Questionnaire Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Episodic Future Thinking', 'description': 'Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic future thinking focused condition. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention, focused on generating future, pleasant events with their children. After the intervention session, parents will receive a daily postcard over the course of two weeks including a reminder cue generated as part of the episodic future thinking (EFT) intervention and a prompt to remember these episodes in vivid detail.\n\nEpisodic Future Thinking: The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in the future with their children.'}], 'classes': [{'title': 'Involved Parenting at Baseline', 'categories': [{'measurements': [{'value': '38.93', 'spread': '6.08', 'groupId': 'OG000'}]}]}, {'title': 'Positive Parenting at Baseline', 'categories': [{'measurements': [{'value': '26.5', 'spread': '2.79', 'groupId': 'OG000'}]}]}, {'title': 'Poor Parental Monitoring at Baseline', 'categories': [{'measurements': [{'value': '15.22', 'spread': '4.54', 'groupId': 'OG000'}]}]}, {'title': 'Inconsistent Parenting at Baseline', 'categories': [{'measurements': [{'value': '15.14', 'spread': '3.84', 'groupId': 'OG000'}]}]}, {'title': 'Corporal Punishment at Baseline', 'categories': [{'measurements': [{'value': '5.21', 'spread': '1.93', 'groupId': 'OG000'}]}]}, {'title': 'Involved Parenting at Follow-Up', 'categories': [{'measurements': [{'value': '38.94', 'spread': '6.88', 'groupId': 'OG000'}]}]}, {'title': 'Positive Parenting at Follow-Up', 'categories': [{'measurements': [{'value': '25.71', 'spread': '3.38', 'groupId': 'OG000'}]}]}, {'title': 'Poor Parental Monitoring at Follow-Up', 'categories': [{'measurements': [{'value': '16.43', 'spread': '4.80', 'groupId': 'OG000'}]}]}, {'title': 'Inconsistent Parenting at Follow-Up', 'categories': [{'measurements': [{'value': '15.66', 'spread': '3.96', 'groupId': 'OG000'}]}]}, {'title': 'Corporal Punishment at Follow-Up', 'categories': [{'measurements': [{'value': '5.07', 'spread': '1.54', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.498', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.01', 'groupDescription': 'Examined changes in parental involvement using a paired-samples t-test.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.108', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.301', 'groupDescription': 'Examined changes in positive parenting using paired samples t-tests', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.145', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.01', 'groupDescription': 'Examined changes in parental monitoring using a paired samples t-test', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.252', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.688', 'groupDescription': 'Examined changes in inconsistent parenting using a paired samples one-sided t-test', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.382', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.306', 'groupDescription': 'Examined changes in corporal punishment using a paired samples one-tailed t-test', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks', 'description': 'The Alabama Parenting Questionnaire (APQ) is a 42-item self-report measure of parenting behaviors which yields five subscales: (1) positive involvement with children (range 10-50, higher = more involvement), (2) use of positive parenting strategies (range 6-30, higher = more positive strategies), (3) poor parental monitoring/supervision (range 10-50, higher = worse supervision), (4) inconsistent discipline (range 6-30, higher = more inconsistent discipline), and (5) use of corporal punishment (range 3-15, higher = more corporal punishment). Items are summed to create subscale scores. Change in each of the five APQ subscale scores will be measured by comparing post-intervention scores (approximately 4 weeks after baseline) with baseline scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All parents who completed the APQ at baseline and post-intervention were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Episodic Future Thinking', 'description': 'Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic future thinking focused condition. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention, focused on generating future, pleasant events with their children. After the intervention session, parents will receive a daily postcard over the course of two weeks including a reminder cue generated as part of the episodic future thinking (EFT) intervention and a prompt to remember these episodes in vivid detail.\n\nEpisodic Future Thinking: The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in the future with their children.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '20 adults, 18 children', 'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'Completed Baseline Questionnaire', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Completed Parent Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Completed Parent-Child Interaction (PCI)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Episodic Future Thinking', 'description': 'Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic future thinking focused condition. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention, focused on generating future, pleasant events with their children. After the intervention session, parents will receive a daily postcard over the course of two weeks including a reminder cue generated as part of the episodic future thinking (EFT) intervention and a prompt to remember these episodes in vivid detail.\n\nEpisodic Future Thinking: The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in the future with their children.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Adult Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37.6', 'spread': '5.7', 'groupId': 'BG000'}]}]}, {'title': 'Child Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '1.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Demographic data reported separately for parent and child participants.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Parent participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Child participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Demographic data presented separately for parent and child participants.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Parent participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Child participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Demographic data reported separately for parent and child participants.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Parent Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '00', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Child Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Demographic data reported separately for parent and child participants.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analyses of self-reported outcomes include only (n=15) parents who completed baseline and post-intervention. Additionally, only a subset of parents received the 5-trial adjusting measure. Only parent-child dyads that completed both the baseline and post-intervention parent-child interactions (n=6) were included in DPICS analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-07', 'size': 320373, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-19T09:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-22', 'studyFirstSubmitDate': '2022-01-18', 'resultsFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-22', 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Delay Discounting 5 Trial Adjusted Measure', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The 5-Trial Adjusting Delay (Temporal Discounting) Task is a computer based system which uses an adjusting algorithm to determine the amount of immediately available money that is equivalent to a large sum that is delayed by seven discrete durations of time presented in a randomized order (i.e., 1 day, 1 week, 1 month, 6 months, 1 year, 5 years, and 25 years). The length of delay is titrated based on participants\' responses to previous items to determine an "indifference point" (the point at which the sums of money are perceived as equal). This is then converted to a k-value and logarithmically transformed to ensure the values are normally distributed, making them unbounded by min and max values. Higher k-values indicate a greater preference for immediate rewards. Change in Delay Discounting is evaluated by comparing baseline k-value scores with scores at the intervention (approximately 1 week after baseline) and the post-intervention assessment (approximately 4 weeks after baseline).'}, {'measure': 'Change in Consideration of Future Consequences Scale - Parenting Adapted', 'timeFrame': 'Baseline, 4 weeks', 'description': 'The Consideration of Future Consequences Scale-Parenting Adapted (CFCS-14-PA) is a 14-item self-report questionnaire composed of two subscales reflecting either immediate or future orientation related to parents interactions with their children. Items range from "not at all like me" (1) to "very much like me" (5) and are summed to create a total score with higher values reflecting greater future orientation. Scores range from 14 to 70. Change in CFCS-14-PA score is measured by comparing scores at the post-intervention assessment (approximately 4 weeks after baseline) with baseline scores.'}], 'secondaryOutcomes': [{'measure': 'Change in Dyadic Parent-Child Interaction Coding System Scores', 'timeFrame': 'Baseline, 4 weeks', 'description': 'Parents and their children will complete a 20-minute interaction task, including 5 min. of free play, a 10 min. "homework" task, and a 5 min. clean up task. Interactions are recorded and coded using the Dyadic Parent-Child Interaction Coding System (DPICS), measuring the quality of parent and child interactions. The task is coded for 7 subscales, yielding 2 composite scores: positive parenting (a sum of: unlabeled praise, labeled praise, positive touch, reflection, and behavior description) and negative parenting (a sum of: negative talk and negative touch). Each instance of a behaviors described in the subscale (e.g., a parent giving unlabeled praise) is coded as one "point," which are summed into a subscale (no max or min values). Higher values indicate greater positive or negative parenting. 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).'}, {'measure': 'Change in Alabama Parenting Questionnaire Scores', 'timeFrame': 'Baseline, 4 weeks', 'description': 'The Alabama Parenting Questionnaire (APQ) is a 42-item self-report measure of parenting behaviors which yields five subscales: (1) positive involvement with children (range 10-50, higher = more involvement), (2) use of positive parenting strategies (range 6-30, higher = more positive strategies), (3) poor parental monitoring/supervision (range 10-50, higher = worse supervision), (4) inconsistent discipline (range 6-30, higher = more inconsistent discipline), and (5) use of corporal punishment (range 3-15, higher = more corporal punishment). Items are summed to create subscale scores. Change in each of the five APQ subscale scores will be measured by comparing post-intervention scores (approximately 4 weeks after baseline) with baseline scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['episodic future thinking', 'delay discounting', 'parent-child relations', 'low income', 'substance use treatment'], 'conditions': ['Behavioral Health']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Staton-Tindall M, Sprang G, Clark J, Walker-Barnes R, Craig CD. Caregiver Substance Use and Child Outcomes: A Systematic Review. Journal of Social Work Practice in the Addictions. 2013;13(1):6-31. doi:10.1080/1533256X.2013.752272'}, {'pmid': '24757747', 'type': 'BACKGROUND', 'citation': 'Committee on Child Maltreatment Research, Policy, and Practice for the Next Decade: Phase II; Board on Children, Youth, and Families; Committee on Law and Justice; Institute of Medicine; National Research Council; Petersen AC, Joseph J, Feit M, editors. New Directions in Child Abuse and Neglect Research. Washington (DC): National Academies Press (US); 2014 Mar 25. Available from http://www.ncbi.nlm.nih.gov/books/NBK195985/'}, {'pmid': '6863704', 'type': 'BACKGROUND', 'citation': 'Herrenkohl RC, Herrenkohl EC, Egolf BP. Circumstances surrounding the occurrence of child maltreatment. J Consult Clin Psychol. 1983 Jun;51(3):424-31. doi: 10.1037//0022-006x.51.3.424. No abstract available.'}, {'pmid': '9158904', 'type': 'BACKGROUND', 'citation': 'Whipple EE, Richey CA. Crossing the line from physical discipline to child abuse: how much is too much? Child Abuse Negl. 1997 May;21(5):431-44. doi: 10.1016/s0145-2134(97)00004-5.'}, {'pmid': '24479151', 'type': 'BACKGROUND', 'citation': 'Alati R, Baker P, Betts KS, Connor JP, Little K, Sanson A, Olsson CA. The role of parental alcohol use, parental discipline and antisocial behaviour on adolescent drinking trajectories. Drug Alcohol Depend. 2014 Jan 1;134:178-84. doi: 10.1016/j.drugalcdep.2013.09.030.'}, {'pmid': '17446567', 'type': 'BACKGROUND', 'citation': 'Young NK, Boles SM, Otero C. Parental substance use disorders and child maltreatment: overlap, gaps, and opportunities. Child Maltreat. 2007 May;12(2):137-49. doi: 10.1177/1077559507300322.'}, {'pmid': '17110792', 'type': 'BACKGROUND', 'citation': 'Reynolds B. A review of delay-discounting research with humans: relations to drug use and gambling. Behav Pharmacol. 2006 Dec;17(8):651-67. doi: 10.1097/FBP.0b013e3280115f99.'}, {'pmid': '11177521', 'type': 'BACKGROUND', 'citation': 'Bickel WK, Marsch LA. Toward a behavioral economic understanding of drug dependence: delay discounting processes. Addiction. 2001 Jan;96(1):73-86. doi: 10.1046/j.1360-0443.2001.961736.x.'}, {'pmid': '27450931', 'type': 'BACKGROUND', 'citation': 'Amlung M, Vedelago L, Acker J, Balodis I, MacKillop J. Steep delay discounting and addictive behavior: a meta-analysis of continuous associations. Addiction. 2017 Jan;112(1):51-62. doi: 10.1111/add.13535. Epub 2016 Sep 1.'}, {'pmid': '21373791', 'type': 'BACKGROUND', 'citation': 'MacKillop J, Amlung MT, Few LR, Ray LA, Sweet LH, Munafo MR. Delayed reward discounting and addictive behavior: a meta-analysis. Psychopharmacology (Berl). 2011 Aug;216(3):305-21. doi: 10.1007/s00213-011-2229-0. Epub 2011 Mar 4.'}, {'pmid': '31916829', 'type': 'BACKGROUND', 'citation': 'Felton JW, Collado A, Ingram K, Lejuez CW, Yi R. Changes in delay discounting, substance use, and weight status across adolescence. Health Psychol. 2020 May;39(5):413-420. doi: 10.1037/hea0000833. Epub 2020 Jan 9.'}, {'pmid': '31610688', 'type': 'BACKGROUND', 'citation': 'Milligan K, Meixner T, Tremblay M, Tarasoff LA, Usher A, Smith A, Niccols A, Urbanoski KA. Parenting Interventions for Mothers With Problematic Substance Use: A Systematic Review of Research and Community Practice. Child Maltreat. 2020 Aug;25(3):247-262. doi: 10.1177/1077559519873047. Epub 2019 Oct 14.'}, {'pmid': '25939033', 'type': 'BACKGROUND', 'citation': 'Neger EN, Prinz RJ. Interventions to address parenting and parental substance abuse: conceptual and methodological considerations. Clin Psychol Rev. 2015 Jul;39:71-82. doi: 10.1016/j.cpr.2015.04.004. Epub 2015 Apr 24.'}, {'pmid': '18205039', 'type': 'BACKGROUND', 'citation': 'Kaminski JW, Valle LA, Filene JH, Boyle CL. A meta-analytic review of components associated with parent training program effectiveness. J Abnorm Child Psychol. 2008 May;36(4):567-89. doi: 10.1007/s10802-007-9201-9. Epub 2008 Jan 19.'}, {'pmid': '24312341', 'type': 'BACKGROUND', 'citation': 'Liu L, Feng T, Chen J, Li H. The value of emotion: how does episodic prospection modulate delay discounting? PLoS One. 2013 Nov 28;8(11):e81717. doi: 10.1371/journal.pone.0081717. eCollection 2013.'}, {'pmid': '20399735', 'type': 'BACKGROUND', 'citation': 'Peters J, Buchel C. Episodic future thinking reduces reward delay discounting through an enhancement of prefrontal-mediotemporal interactions. Neuron. 2010 Apr 15;66(1):138-48. doi: 10.1016/j.neuron.2010.03.026.'}, {'pmid': '24512061', 'type': 'BACKGROUND', 'citation': 'Lin H, Epstein LH. Living in the moment: effects of time perspective and emotional valence of episodic thinking on delay discounting. Behav Neurosci. 2014 Feb;128(1):12-9. doi: 10.1037/a0035705.'}]}, 'descriptionModule': {'briefSummary': "Parents with substance use disorders are disproportionately more likely to engage in harsh physical discipline, which can lead to serious clinical outcomes, including child maltreatment and the intergenerational transmission of addictive disorders. One mechanism linking substance use and maladaptive parenting strategies is parental delay discounting, or the tendency to value smaller, immediate rewards (such as stopping children's misbehavior via physical punishment) relative to larger, but delayed rewards (like shaping adaptive child behaviors over time). This study will examine the efficacy of implementing a low-cost, brief intervention targeting the reduction of parental delay discounting to inform broader public health efforts aimed at reducing child maltreatment and interrupting intergenerational cycles of substance abuse in traditionally underserved communities.", 'detailedDescription': "Parents with substance use disorders (SUD) are significantly more likely to engage in harsh parenting practices, including spanking, hitting, and belittling their children, than parents without SUD. Punitive physical and emotional discipline is, in turn, associated with increased rates of child maltreatment and the subsequent intergenerational transmission of substance use disorders. Parents in residential substance use treatment facilities are among those at highest risk for perpetrating harsh and abusive parenting; yet most behaviorally based parenting interventions available within inpatient settings do not take into account the unique mechanisms linking parental substance use to harsh parenting. Specifically, parents with SUD may be at heightened risk for engaging in maladaptive parenting approaches given a tendency to prioritize immediate rewards (such as stopping a child's misbehavior using physical punishment) relative to larger, but delayed rewards (including shaping positive child behavior over a longer term). This behavioral tendency is known as delay discounting and recent findings suggest that rates of delay discounting predict parents' use of harsh physical discipline. Existing research also indicates a strong link between steeper (more problematic) rates of delay discounting and the severity of alcohol and illicit drug use across the lifespan. Thus, delay discounting may represent a specific vulnerability underlying both harsh parenting and disordered substance use. The current project proposes to pilot and feasibility test an adapted episodic future thinking (EFT) intervention to target the reduction of parenting-related delay discounting and examine its effects on parenting practices among families in a residential substance use treatment setting. The intervention will be delivered by peer recovery coaches who are already employed in the center."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent of child between 6-10 years of age\n* Able to provide informed consent and take part in all study procedures in English\n* Have current diagnosis of SUD\n* Currently reside with their child at least 50% of the time\n* Be willing to receive daily postcards\n\nExclusion Criteria:\n\n* Active suicidality/homicidally\n* Active bipolar disorder, schizophrenia, or psychosis.\n* Only one parent-child dyad from each family.'}, 'identificationModule': {'nctId': 'NCT05229120', 'briefTitle': 'Improving Delay Discounting to Decrease Harsh Parenting Among Parents Receiving Substance Use Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Improving Delay Discounting to Decrease Harsh Parenting Among Parents Receiving Substance Use Treatment in Low Income Community', 'orgStudyIdInfo': {'id': 'NAP: 14781-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Episodic Future Thinking', 'description': 'Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic future thinking focused condition. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention, focused on generating future, pleasant events with their children. After the intervention session, parents will receive a daily postcard over the course of two weeks including a reminder cue generated as part of the episodic future thinking (EFT) intervention and a prompt to remember these episodes in vivid detail.', 'interventionNames': ['Behavioral: Episodic Future Thinking']}], 'interventions': [{'name': 'Episodic Future Thinking', 'type': 'BEHAVIORAL', 'description': 'The adapted episodic future thinking (EFT) intervention will focus on generation of vivid, substance-free, rewarding events that could happen in the future with their children.', 'armGroupLabels': ['Episodic Future Thinking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48502', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Odyssey Village', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}], 'overallOfficials': [{'name': 'Julia Felton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Maryland, College Park', 'class': 'OTHER'}, {'name': 'University of Kansas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Scientist', 'investigatorFullName': 'Julia Felton', 'investigatorAffiliation': 'Henry Ford Health System'}}}}