Substance Use Prevention for Youth With Parents in Recovery

Substance Use Disorders Clinical Trial

Official title:

Substance Use Prevention for Youth With Parents in Recovery: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397691
• Other study ID #: 2022003505
• Secondary ID: 1R34DA052836-01A
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: Brown University
• Contact: Caroline J Kistin, MD MSc
• Phone: 4018632236
• Email: caroline_kistin[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Risk for substance use disorder (SUD) begins early in the life course. Although preventing and decreasing illicit and nonmedical drug use among youth is an urgent public health priority, there are currently few evidence-based prevention strategies feasible for delivery in the primary care setting. The investigators propose a three-year plan to collect critical pilot data to pilot test and optimize a dyadic intervention that aims to increase family resilience, strengthen coping skills, help families plan for the future, and prevent youth SUD. The 'prototype' for the intervention approach is Family Talk, an evidence-based parent-youth dyadic intervention that can be delivered within the existing infrastructure of the patient-centered medical home. The investigators have made preliminary adaptations to the model in preparation for testing. To prepare for a subsequent efficacy study, a two-arm pilot randomized controlled trial of the intervention with 40 parent-youth dyads to optimize the intervention model will be conducted. The feasibility of the intervention will be evaluated. In addition, empiric estimates of study parameters to inform the planning of a fully powered randomized controlled trial and plausible intervention targets using semi-structured qualitative interviews will be obtained.

Description:

Within the context of a pilot randomized controlled trial, the objectives are to: 1. Optimize the content and delivery of the intervention through an iterative series of quality improvement cycles informed by structured feedback from parents, youth, and intervention providers after each session; 2. Field test study logistics, including participant recruitment, willingness to consent to a randomized trial; loss to follow-up; the acceptability and feasibility of the study measures; and 3. Obtain empiric estimates of study parameters to inform future clinical trial design, including within-group standard deviation of continuous measures; correlations of repeated measures; and proportion of control group subjects who experience each outcome. The products at the end of the pilot study will be an optimized intervention model, developed with parent and youth input and ready for efficacy testing; and a set of putative intervention targets ready to be tested in the subsequent trial. The ultimate goal is to develop an effective approach to youth substance use prevention, delivered within the infrastructure of the patient-centered medical home. If successful, this trajectory of work has the potential to identify a novel, family-centered approach to substance use disorder prevention for a high-risk population of youth whose parents are in recovery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria for youth:

• 12-18 years without diagnosed SUD
• Comfortable speaking English or Spanish

Inclusion Criteria for parent:

• 18 years or older
• Receiving treatment for SUD
• Receiving substance use care in the CODAC system
• Comfortable speaking English or Spanish

Exclusion Criteria:

• Presence of acute family crisis, such as recent death, incarceration, separation, divorce, or other stressor
• Parent or youth with cognitive limitation or intellectual disability

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Modified Family Talk
The Modified Family Talk intervention consists of six modules, each lasting approximately 60 minutes. Family Talk is intended to be delivered over a period of 12 weeks, with meetings occurring every 1-2 weeks.
• Control-like parameter estimation
Parameter estimation is designed to emulate best practices around comprehensive, high quality, patient-centered care for adults and youth. Participants will have access to collaborative adult Office Based Addiction Treatment (OBAT) clinical services, multidisciplinary adolescent primary care clinics with co-located adolescent substance use specialists, high quality social work services, integrated behavioral health, and access to patient navigators for assistance connecting to community resources.

Locations

Country	Name	City	State
United States	CODAC	Pawtucket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation metrics	The number of families approached and screened for the project, number ineligible, number refusing participation, and number ultimately enrolled will be assessed	12 months
Primary	Reasons for not enrolling	An investigator created questionnaire will be obtain the reasons why eligible potential participants did not enroll in the study.	12 months
Primary	Study attrition rates	The percent of participants will be calculated by dividing the number of participants that complete the study by the total number of participants enrolled.	12 months
Primary	Number of sessions	The number of sessions delivered by the intervention providers will be tracked.	throughout the study up to 12 months
Primary	Person-time of sessions	The total and average person time for sessions delivered by the intervention providers will be tracked.	throughout the study up to 12 months
Secondary	Youth substance use in preceding 90 days	The Timeline Follow-back Interview (TLFB) is a 14 item instrument that will be used to assess substance use in the preceding 90 days and to evaluate for new onset of substance use, as well as increased frequency or intensity of use.	90 days
Secondary	Youth substance use screening	Brief Screener for Tobacco, Alcohol, and other Drugs (BSTAD), a brief, validated instrument designed for use in primary care will be used to screen youth for substance use, including use of tobacco (adapted to include e-cigarettes and vaping products), alcohol, marijuana, prescription medications (including opioids), heroin, and other illicit substance use in the past year.	12 months
Secondary	Family Communication	Family communication will be assessed by the 10-item Family Problem-Solving Communication Index that evaluates family communication patterns in response to problems or conflicts and identifies affirming and incendiary communication patterns. Each item has a choice of answers, which correlate with 0-3 points where 0 = False' 1 = Mostly false' 2 = Mostly true' 3 = True. The answers to different items are added together for an "affirming communication" subscale and an "incendiary communication" subscale. Reverse score items 3 & 9. For Affirming Communication: items 2' 4' and 6' 8'10 are summed. For Incendiary Communication: items 1' 3' 5' 7' 9 are summed. The subscales can range from 0-15. Higher scores for the affirming communication subscale are more favorable, while lower scores for the incendiary communication subscale are more favorable.	3 months, 6 months, 12 months
Secondary	Family Functioning	The Inventory of Parent and Peer Attachment (IPPA) will be used to assess family functioning. IPPA consists of 25 items for the mother, 25 items for the father, and 25 items for the adolescent and uses a 5-point LIkert scale for each items. The IPPA is scored by reverse-scoring the negatively worded items and then summing the response values in each section. This self-report scale measures youth perceptions of attachment to parents/caregivers along three dimensions: trust, communication, and alienation	3 months, 6 months, 12 months
Secondary	Depression	Depression will be assessed using the Quick Inventory of Depressive Symptomatology (QIDS).Total QIDS scores range from 0 to 27, with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.	3 months, 6 months, 12 months
Secondary	Perceived Stress	Perceived stress will be assessed using the 10 item Perceived Stress Scale (PSS). The range of responses for each item is from 0-4, where 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. total scores can range from 0 to 40 and higher scores are correlated with more perceived stress.	3 months, 6 months, 12 months
Secondary	Problem solving skills	Problem solving skills will be assessed with the Social Problem Solving Inventory -Revised (SPSI-R). This 25 item instrument measures problem orientation and problem-solving skills in 5 dimensions: positive (PPO) and negative orientation(NPO) ; avoidance (AS); impulsivity (ICS) ; and rationality (RPS). Each dimension subscale scores range from 0 to 20, and the total scores of the SPSI-R: S range from 0 to 100. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.	3 months, 6 months, 12 months
Secondary	Self-efficacy coping strategies	Coping strategies will be assessed by the 26 item Coping Self-Efficacy Scale which measures ability to cope with life changes in three domains: problem-focused coping, handling unpleasant thoughts, and getting support from family/friends. Anchor points on the scale are 0 ('cannot do at all'), 5 ('moderately certain can do') and 10 ('certain can do'). A high score - between 17 and 20 - indicates a highly resilient coper, and a low score - between 4 and 13 - suggests a low resilient coper.	3 months, 6 months, 12 months
Secondary	Types of coping strategies	The Brief Coping Orientation to Problems Experienced (COPE) measures 14 different adaptive and problematic coping styles. Respondents rate items on a 4-point Likert scale ranging from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). Each scale is comprised of 2 items. Higher scores indicate increased utilization of that specific coping strategy. There is no overall total score.	3 months, 6 months, 12 months
Secondary	Social support	Social support will be assessed using the Social Adjustment Scale Self-Report (SAS-SR). It examines social and role functioning in six areas: work; social activities; relationships with family; spouse or partner; parent; member of family unit. Each question is rated on a five-point scale from which subscale means and an overall mean can be obtained. Higher scores denote greater impairment. Role areas not relevant to the respondent can be skipped	3 months, 6 months, 12 months
Secondary	Youth perceptions of peer, sibling, parental substance use	The Personal Experience Inventory will be used to assess this outcome. It assesses 3 domains: peer use (5 items); sibling use (4 items); and parent use (4 items). The response options include Likert scales that correspond to answers such as Never/Once or Twice/Sometimes/Often, Strongly Disagree/Disagree/Agree/Strongly Agree, which in turn correspond to scores of 1-4. Subscale scores can be compared to population norms and cutoffs.	3 months, 6 months, 12 months