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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05963633




Registration number
NCT05963633
Ethics application status
Date submitted
19/07/2023
Date registered
27/07/2023

Titles & IDs
Public title
Future Thinking to Improve Parent-Child Relationships
Scientific title
Further Forward: Future Thinking to Improve Parent-Child Relationships
Secondary ID [1] 0 0
NARCT: 16430-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavior, Health 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Episodic Future Thinking (EFT)
BEHAVIORAL - Episodic Recent Thinking (ERT)

Experimental: Episodic Future Thinking (EFT) - 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 milestones with their children. The participant will also be allowed to draw or write about the scene, to help them envision it, which they will keep to refer to if they choose. After the intervention session, PRCs will check-in with parents daily over the course of two weeks to practice episodic future thinking (EFT) intervention by asking participants to further elaborate on the milestones they identified in the intervention to prompt these episodes in vivid detail.

Active comparator: Episodic Recent Thinking (ERT) - Parents who are receiving residential substance use disorder (SUD) treatment will receive an adapted episodic recent thinking intervention. Parents will meet with peer recovery coaches (PRCs) who will administer the intervention. During the intervention, the participant will be asked to describe in detail two things they struggled with and two things that went well that occurred during the last few days. The participant will also be allowed to draw or write about the scene, to help them envision it, which they will keep to refer to if they choose. After the intervention session, or present-oriented thinking (in the comparison condition, by asking participants to discuss an event that happened that day PRCs will check-in with parents daily over the course of two weeks to practice episodic future thinking (EFT) intervention by asking participants to further elaborate on the milestones they identified in the intervention to prompt these episodes in vivid detail.


BEHAVIORAL: Episodic Future Thinking (EFT)
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.

BEHAVIORAL: Episodic Recent Thinking (ERT)
In the episodic recent thinking (ERT) condition, the participant will instead describe in vivid details events that have occurred in the recent past.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Delay Discounting 5 Trial Adjusted Measure
Timepoint [1] 0 0
Baseline, Week 2, Week 4, Week 14
Primary outcome [2] 0 0
Change in Consideration of Future Consequences Scale
Timepoint [2] 0 0
Baseline, Week 4, Week 14
Secondary outcome [1] 0 0
Change in Alabama Parenting Questionnaire Scores
Timepoint [1] 0 0
Baseline, Week 4

Eligibility
Key inclusion criteria
1. Be the parent of a child between the ages of 6-10
2. Willing to participate in the study
3. Able to participate in written assessments and an intervention conducted in English
4. Are receiving services at Flint or Saginaw Odyssey House ("Odyssey House")
5. Be willing to receive check-ins regarding intervention content over the two weeks following the intervention
6. Can legally consent for the child to take part in the study and have regular contact with their child
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Self-disclosed active suicidality/homicidality
2. Self-disclosed current bipolar disorder, schizophrenia, or psychosis
3. Study enrollment with more than 1 child

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan

Funding & Sponsors
Primary sponsor type
Other
Name
Henry Ford Health System
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Kansas
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Maryland, College Park
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05963633