Trial Outcomes & Findings for Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes (NCT NCT05747599)

Results Overview

An alcohol metabolite (EtG) will be measured in urine samples. EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking. The dipstick testing will have ≥300 ng/mL as a cutoff value.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

3-month postpartum

Results posted on

2025-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Contingent Incentives + Text-based Support Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Overall Study STARTED	48
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contingent Incentives + Text-based Support n=48 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components Intervention with contingent incentives and text-based support: Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Age, Continuous	30 years STANDARD_DEVIATION 6.0 • n=99 Participants
Sex: Female, Male Female	48 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race/Ethnicity, Customized Mixed	31 Participants n=99 Participants
Race/Ethnicity, Customized Black	17 Participants n=99 Participants
Marital Status Married	9 Participants n=99 Participants
Marital Status Living with a partner	19 Participants n=99 Participants
Marital Status Not living with a partner	16 Participants n=99 Participants
Marital Status Others	4 Participants n=99 Participants
Education 12 years or less	44 Participants n=99 Participants
Education More than 12 years	4 Participants n=99 Participants

PRIMARY outcome

Timeframe: 3-month postpartum

An alcohol metabolite (EtG) will be measured in urine samples. EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking. The dipstick testing will have ≥300 ng/mL as a cutoff value.

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=45 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Number of Participants With Negative Urinalysis for Alcohol Metabolite (EtG)	44 Participants

PRIMARY outcome

Timeframe: 3-month postpartum

Biochemical verification of recent tobacco use in urine samples. A tobacco metabolite (cotinine) will be measured in urine samples. The metabolite can be detected up to 3-4 days after use. The dipstick testing will have ≥200 ng/mL as a cutoff value.

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=45 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Number of Participants With Negative Urinalysis for Nicotine Metabolite (Cotinine)	18 Participants

PRIMARY outcome

Timeframe: 3-month postpartum

Biochemical verification of recent cannabis use in urine samples. A cannabis metabolite (THC) will be measured in urine samples. The metabolite can be detected up to 28 days after heavy use. The dipstick testing will have ≥50 ng/mL as a cutoff value.

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=45 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Number of Participants With Negative Urinalysis for Cannabis Metabolite (THC)	42 Participants

PRIMARY outcome

Timeframe: 3-month postpartum

The number of days in the past 7 days that participants used alcohol.

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=45 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Number of Days in the Past 7-day Alcohol Use	0.2 Days in the past week alcohol use Standard Deviation 0.5

PRIMARY outcome

Timeframe: 3-month postpartum

The number of days in the past 7 days that participants used tobacco.

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=45 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Number of Days in the Past 7-day Tobacco Use	3 Days in the past week tobacco use Standard Deviation 3.4

PRIMARY outcome

Timeframe: 3-month postpartum

The number of days in the past 7 days that participants used cannabis.

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=45 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Number of Days in the Past 7-day Cannabis Use	0.4 Days in the past week cannabis use Standard Deviation 1.4

SECONDARY outcome

Timeframe: 3-month postpartum

The number of days in the past 7 days that participants used cannabis while breastfeeding.

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=45 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Number of Days in the Past 7-day Cannabis Use While Breastfeeding	0.02 Days in the past week BF/Cannabis Standard Deviation 0.1

SECONDARY outcome

Timeframe: 3-month postpartum

The number of days in the past 7 days that participants used tobacco while breastfeeding.

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=45 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Number of Days in the Past 7-day Tobacco Use While Breastfeeding	2 Days in the past week BF/Smoking Standard Deviation 2.8

SECONDARY outcome

Timeframe: 3-month postpartum

The number of days in the past 7 days that participants used alcohol while breastfeeding.

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=45 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Number of Days in the Past 7-day Alcohol Use While Breastfeeding	0.1 Days in the past week BF/Drinking Standard Deviation 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: at birth

birth weight of infants among participants who entered the study during pregnancy

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=23 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Birth Weight (g)	2804 grams Standard Deviation 407

OTHER_PRE_SPECIFIED outcome

Timeframe: at birth

birth length of infants among participants who entered the study during pregnancy

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=22 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Birth Length (cm)	48 cm Standard Deviation 3

OTHER_PRE_SPECIFIED outcome

Timeframe: at birth

Gestational age of infants among participants who entered the study during pregnancy

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=23 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Gestational Age (Weeks)	38 weeks Standard Deviation 2

OTHER_PRE_SPECIFIED outcome

Timeframe: at birth

Head circumference of infants among participants who entered the study during pregnancy

Outcome measures

Outcome measures
Measure	Contingent Incentives + Text-based Support n=22 Participants Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Head Circumference (cm)	33 cm Standard Deviation 2

Adverse Events

Intervention

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=48 participants at risk Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Investigations Infant death	2.1% 1/48 • Number of events 1 • Approximately 6 months
Pregnancy, puerperium and perinatal conditions Miscarriage	2.1% 1/48 • Number of events 1 • Approximately 6 months

Other adverse events

Other adverse events
Measure	Intervention n=48 participants at risk Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Blood and lymphatic system disorders High blood pressure	2.1% 1/48 • Number of events 1 • Approximately 6 months
Pregnancy, puerperium and perinatal conditions Preterm labor	2.1% 1/48 • Number of events 1 • Approximately 6 months

Additional Information

Yukiko Washio, PhD

RTIInternational

Phone: 9194852794

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place