Adults 9 to 14, any sex, with Substance-Related Disorders or Underage Drinking. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Frequency of Parent-child Conversations on SubstancesPrimary· 3 months (short-term) and 18 months (long-term)
Frequency of conversations was measured using an item adapted from a measure for parent-child communication about sex (Miller et al, 1998).
Question: "During the past 3-months, how many times have you and your child talked about \[substance\]?" The same question assessed frequency for each substance of interest (alcohol, cigarettes, e-cigarettes, cannabis, other drugs) on a five-point Likert scale from "None" to "A lot". Responses were dichotomized as "Several" or "A lot" versus "None", "Once", or "A few times".
This measure was reported by parents and children.
3-months - drinking alcohol
Group
Value
95% CI
Substance Use Prevention Intervention
87
Substance Use Prevention Intervention - Children
32
Nutrition, Physical Activity, and Weight Talk Comparison
29
Nutrition, Physical Activity, and Weight Talk Comparison - Children
20
Substance Use Prevention Intervention
91
Substance Use Prevention Intervention - Children
146
Nutrition, Physical Activity, and Weight Talk Comparison
156
Nutrition, Physical Activity, and Weight Talk Comparison - Children
165
3-months - using e-cigarettes or vaping
Group
Value
95% CI
Substance Use Prevention Intervention
70
Substance Use Prevention Intervention - Children
28
Nutrition, Physical Activity, and Weight Talk Comparison
28
Nutrition, Physical Activity, and Weight Talk Comparison - Children
17
Substance Use Prevention Intervention
108
Substance Use Prevention Intervention - Children
150
Nutrition, Physical Activity, and Weight Talk Comparison
157
Nutrition, Physical Activity, and Weight Talk Comparison - Children
168
3-months - using marijuana
Group
Value
95% CI
Substance Use Prevention Intervention
61
Substance Use Prevention Intervention - Children
20
Nutrition, Physical Activity, and Weight Talk Comparison
27
Nutrition, Physical Activity, and Weight Talk Comparison - Children
17
Substance Use Prevention Intervention
117
Substance Use Prevention Intervention - Children
158
Nutrition, Physical Activity, and Weight Talk Comparison
158
Nutrition, Physical Activity, and Weight Talk Comparison - Children
168
3-months - smoking cigarettes
Group
Value
95% CI
Substance Use Prevention Intervention
79
Substance Use Prevention Intervention - Children
28
Nutrition, Physical Activity, and Weight Talk Comparison
23
Nutrition, Physical Activity, and Weight Talk Comparison - Children
21
Substance Use Prevention Intervention
99
Substance Use Prevention Intervention - Children
150
Nutrition, Physical Activity, and Weight Talk Comparison
162
Nutrition, Physical Activity, and Weight Talk Comparison - Children
164
3-months - using other drugs
Group
Value
95% CI
Substance Use Prevention Intervention
55
Substance Use Prevention Intervention - Children
25
Nutrition, Physical Activity, and Weight Talk Comparison
20
Nutrition, Physical Activity, and Weight Talk Comparison - Children
19
Substance Use Prevention Intervention
123
Substance Use Prevention Intervention - Children
153
Nutrition, Physical Activity, and Weight Talk Comparison
165
Nutrition, Physical Activity, and Weight Talk Comparison - Children
166
18-months - drinking alcohol
Group
Value
95% CI
Substance Use Prevention Intervention
51
Substance Use Prevention Intervention - Children
30
Nutrition, Physical Activity, and Weight Talk Comparison
36
Nutrition, Physical Activity, and Weight Talk Comparison - Children
28
Substance Use Prevention Intervention
106
Substance Use Prevention Intervention - Children
121
Nutrition, Physical Activity, and Weight Talk Comparison
124
Nutrition, Physical Activity, and Weight Talk Comparison - Children
131
18-months - using e-cigarettes or vaping
Group
Value
95% CI
Substance Use Prevention Intervention
40
Substance Use Prevention Intervention - Children
22
Nutrition, Physical Activity, and Weight Talk Comparison
33
Nutrition, Physical Activity, and Weight Talk Comparison - Children
18
Substance Use Prevention Intervention
117
Substance Use Prevention Intervention - Children
129
Nutrition, Physical Activity, and Weight Talk Comparison
127
Nutrition, Physical Activity, and Weight Talk Comparison - Children
141
18-months - using marijuana
Group
Value
95% CI
Substance Use Prevention Intervention
38
Substance Use Prevention Intervention - Children
26
Nutrition, Physical Activity, and Weight Talk Comparison
30
Nutrition, Physical Activity, and Weight Talk Comparison - Children
22
Substance Use Prevention Intervention
119
Substance Use Prevention Intervention - Children
125
Nutrition, Physical Activity, and Weight Talk Comparison
130
Nutrition, Physical Activity, and Weight Talk Comparison - Children
137
Targeted Parent-child Communication on Substance UsePrimary· 3 months (short-term) and 18 months (long-term)
An adapted version of the Targeted Parent-Child Communication about Alcohol Scale (Miller-Day et al, 2010) was used to assess targeted communication about alcohol and other drugs use. The ten-item assesses parents' agreement on having communication about substance use related topics and applying strategies parents may have discussed with their child. Items were assessed on a six-point Likert scale from "Strongly agree" to "Strongly disagree". Responses were dichotomized as "Agree" or "Strongly Agree" versus "Strongly Disagree" to "Somewhat Agree".
This measure was reported by parents and chil
3 months - warned about the dangers
Group
Value
95% CI
Substance Use Prevention Intervention
162
Substance Use Prevention Intervention - Children
147
Nutrition, Physical Activity, and Weight Talk Comparison
126
Nutrition, Physical Activity, and Weight Talk Comparison - Children
143
Substance Use Prevention Intervention
19
Substance Use Prevention Intervention - Children
34
Nutrition, Physical Activity, and Weight Talk Comparison
59
Nutrition, Physical Activity, and Weight Talk Comparison - Children
42
3 months - talked about how to handle offers
Group
Value
95% CI
Substance Use Prevention Intervention
137
Substance Use Prevention Intervention - Children
125
Nutrition, Physical Activity, and Weight Talk Comparison
81
Nutrition, Physical Activity, and Weight Talk Comparison - Children
106
Substance Use Prevention Intervention
44
Substance Use Prevention Intervention - Children
56
Nutrition, Physical Activity, and Weight Talk Comparison
104
Nutrition, Physical Activity, and Weight Talk Comparison - Children
79
3 months - given rules to obey
Group
Value
95% CI
Substance Use Prevention Intervention
139
Substance Use Prevention Intervention - Children
111
Nutrition, Physical Activity, and Weight Talk Comparison
61
Nutrition, Physical Activity, and Weight Talk Comparison - Children
104
Substance Use Prevention Intervention
42
Substance Use Prevention Intervention - Children
70
Nutrition, Physical Activity, and Weight Talk Comparison
124
Nutrition, Physical Activity, and Weight Talk Comparison - Children
81
3 months - not directly talked but given hints on not to use
Group
Value
95% CI
Substance Use Prevention Intervention
18
Substance Use Prevention Intervention - Children
39
Nutrition, Physical Activity, and Weight Talk Comparison
29
Nutrition, Physical Activity, and Weight Talk Comparison - Children
59
Substance Use Prevention Intervention
163
Substance Use Prevention Intervention - Children
142
Nutrition, Physical Activity, and Weight Talk Comparison
156
Nutrition, Physical Activity, and Weight Talk Comparison - Children
126
3 months - lectured or given speech
Group
Value
95% CI
Substance Use Prevention Intervention
71
Substance Use Prevention Intervention - Children
83
Nutrition, Physical Activity, and Weight Talk Comparison
41
Nutrition, Physical Activity, and Weight Talk Comparison - Children
68
Substance Use Prevention Intervention
110
Substance Use Prevention Intervention - Children
98
Nutrition, Physical Activity, and Weight Talk Comparison
144
Nutrition, Physical Activity, and Weight Talk Comparison - Children
117
3 months - made a comment if a character on TV is drinking/drunk
Group
Value
95% CI
Substance Use Prevention Intervention
83
Substance Use Prevention Intervention - Children
84
Nutrition, Physical Activity, and Weight Talk Comparison
57
Nutrition, Physical Activity, and Weight Talk Comparison - Children
64
Substance Use Prevention Intervention
98
Substance Use Prevention Intervention - Children
97
Nutrition, Physical Activity, and Weight Talk Comparison
128
Nutrition, Physical Activity, and Weight Talk Comparison - Children
121
3 months - told stories of people who drink or have been drunk or use drugs
Group
Value
95% CI
Substance Use Prevention Intervention
112
Substance Use Prevention Intervention - Children
60
Nutrition, Physical Activity, and Weight Talk Comparison
86
Nutrition, Physical Activity, and Weight Talk Comparison - Children
60
Substance Use Prevention Intervention
69
Substance Use Prevention Intervention - Children
121
Nutrition, Physical Activity, and Weight Talk Comparison
99
Nutrition, Physical Activity, and Weight Talk Comparison - Children
125
3 months - told they would be disappointed
Group
Value
95% CI
Substance Use Prevention Intervention
88
Substance Use Prevention Intervention - Children
77
Nutrition, Physical Activity, and Weight Talk Comparison
47
Nutrition, Physical Activity, and Weight Talk Comparison - Children
71
Substance Use Prevention Intervention
93
Substance Use Prevention Intervention - Children
104
Nutrition, Physical Activity, and Weight Talk Comparison
138
Nutrition, Physical Activity, and Weight Talk Comparison - Children
114
Parent-child Audio-recorded Conversations About Substance UsePrimary· 12 months
The prompts, modeled after the Family Assessment Task (FAsTask) where parents and adolescents have a conversation about substance use and related behaviors, were developed by the study team (Spirito et al, 2011). The same prompts are used at each time point. The sub-scales (expectations, messaging, communication style, and strategies) range from 1 to 9 (higher values represent a higher quality conversation compared to lower values). The overall combined score ranges from 4 to 36 (higher values represent a higher quality conversation compared to lower values).
Expectations
Group
Value
95% CI
Substance Use Prevention Intervention
3.5
± 2.1
Nutrition, Physical Activity, and Weight Talk Comparison
3.2
± 1.9
Messaging
Group
Value
95% CI
Substance Use Prevention Intervention
4.7
± 1.3
Nutrition, Physical Activity, and Weight Talk Comparison
4.6
± 1.3
Communication style
Group
Value
95% CI
Substance Use Prevention Intervention
5.5
± 1.6
Nutrition, Physical Activity, and Weight Talk Comparison
5.5
± 1.5
Strategies
Group
Value
95% CI
Substance Use Prevention Intervention
2.4
± 1.8
Nutrition, Physical Activity, and Weight Talk Comparison
2.2
± 1.5
Overall combined score
Group
Value
95% CI
Substance Use Prevention Intervention
16
± 4.0
Nutrition, Physical Activity, and Weight Talk Comparison
15.5
± 3.5
Quality of Video-recorded Family Mealtime InteractionsPrimary· 12 months
The mean quality of mealtime interactions is measured using various scales from the Iowa Family Interaction Rating Scales (IFIRS) coding system: Dyadic Interaction Scales, Dyadic Relationship Scales, Group Interactions Scales, and Parenting Scales. Observed behaviors from 3 video-recorded family meals are assessed and scored on a 9-point scale. A higher score indicates coders observed a higher intensity and/or frequency of the construct in the video-recorded family meals. Each IFIRS scale is scored individually, and the average across the 3 family meals is reported. The items were organized in
Parent communication
Group
Value
95% CI
Substance Use Prevention Intervention
28.9
± 0.3
Nutrition, Physical Activity, and Weight Talk Comparison
28.6
± 0.3
Parenting style
Group
Value
95% CI
Substance Use Prevention Intervention
30.3
± 0.2
Nutrition, Physical Activity, and Weight Talk Comparison
30.1
± 0.2
Dyad relationship
Group
Value
95% CI
Substance Use Prevention Intervention
25.7
± 0.3
Nutrition, Physical Activity, and Weight Talk Comparison
25.8
± 0.3
Group enjoyment
Group
Value
95% CI
Substance Use Prevention Intervention
4.5
± 0.1
Nutrition, Physical Activity, and Weight Talk Comparison
4.2
± 0.1
Child Substance Use Expectancies (Alcohol)Primary· 18 months
Positive and negative expectancies about the affective, cognitive, and behavioral effects of alcohol use will be assessed with the Alcohol Expectancy Questionnaire-Adolescent Form, short version. The tool is comprised of 27 items, each with response options ranging from (1) Strongly Disagree to (6) Strongly Agree. Questions 6, 9, 17, and 26 are scored in opposite direction before they are included in the negative sub-scale (remaining items are included in the positive sub-scale). Sub-scales are created by averaging the items and range from 1 to 6. A higher score on the positive expectancies sc
Positive expectancies
Group
Value
95% CI
Substance Use Prevention Intervention - Children
2.55
± 0.08
Nutrition, Physical Activity, and Weight Talk Comparison - Children
2.53
± 0.07
Negative expectancies
Group
Value
95% CI
Substance Use Prevention Intervention - Children
4.24
± 0.09
Nutrition, Physical Activity, and Weight Talk Comparison - Children
4.23
± 0.09
Child Substance Use Expectancies (Cigarettes)Primary· 18 months
Positive and negative expectancies about the affective, cognitive, and behavioral effects of cigarette use will be assessed with the Positive and Negative Outcome Expectancies of Smoking scale. The tool comprises 12 items, each with response options ranging from (1) Strongly Disagree to (6) Strongly Agree. The tool has two subscales (positive expectancies, determined by 7 questions; negative expectancies, determined by 5 questions). Summary scores for both the positive and negative expectancies are created. Summary score values range from 0-7 for positive, 0-5 for negative expectancies. Higher
Positive expectancies
Group
Value
95% CI
Substance Use Prevention Intervention - Children
1.68
± 0.05
Nutrition, Physical Activity, and Weight Talk Comparison - Children
1.57
± 0.05
Negative expectancies
Group
Value
95% CI
Substance Use Prevention Intervention - Children
5.15
± 0.07
Nutrition, Physical Activity, and Weight Talk Comparison - Children
5.22
± 0.07
Child Substance Use Expectancies (Marijuana)Primary· 18 months
Positive and negative expectancies about the affective, cognitive, and behavioral effects of marijuana use will be assessed with an adapted version of the Marijuana Effect Expectancies Questionnaire - Brief. The tool comprises three standalone subscales (Relaxation/Tension Reduction, Cognitive/Behavioral Impairment, Global Negative Effects) for a total of 27 items. Each item has responses ranging from (1) Strongly Disagree to (6) Strongly Agree. Scores for each subscale are calculated by averaging item scores within that subscale. Each subscale score range is from 1 - 6. Higher scores on each
Positive expectancies
Group
Value
95% CI
Substance Use Prevention Intervention - Children
2.69
± 0.1
Nutrition, Physical Activity, and Weight Talk Comparison - Children
2.73
± 0.1
Negative expectancies
Group
Value
95% CI
Substance Use Prevention Intervention - Children
4.04
± 0.12
Nutrition, Physical Activity, and Weight Talk Comparison - Children
4.16
± 0.12
Child Affiliation With Substance-using PeersPrimary· 18 months
Using an item from the Monitoring the Future study, children will be asked how many of their friends they think use substances. The item is repeated for each substance.
This measure was reported by children only.
How many of your friends do you estimate occassionally drink alcohol?
Group
Value
95% CI
Substance Use Prevention Intervention - Children
21
Nutrition, Physical Activity, and Weight Talk Comparison - Children
15
Substance Use Prevention Intervention - Children
124
Nutrition, Physical Activity, and Weight Talk Comparison - Children
126
How many of your friends do you think smoke cigarettes?
Group
Value
95% CI
Substance Use Prevention Intervention - Children
11
Nutrition, Physical Activity, and Weight Talk Comparison - Children
4
Substance Use Prevention Intervention - Children
137
Nutrition, Physical Activity, and Weight Talk Comparison - Children
143
How many of your friends do you think use marijuana?
Group
Value
95% CI
Substance Use Prevention Intervention - Children
15
Nutrition, Physical Activity, and Weight Talk Comparison - Children
11
Substance Use Prevention Intervention - Children
131
Nutrition, Physical Activity, and Weight Talk Comparison - Children
137
How many of your friends do you estimate occassionally use e-cigarettes or vapes?
Group
Value
95% CI
Substance Use Prevention Intervention - Children
29
Nutrition, Physical Activity, and Weight Talk Comparison - Children
23
Substance Use Prevention Intervention - Children
117
Nutrition, Physical Activity, and Weight Talk Comparison - Children
119
How many of your friends do you think use other drugs?
Group
Value
95% CI
Substance Use Prevention Intervention - Children
4
Nutrition, Physical Activity, and Weight Talk Comparison - Children
2
Substance Use Prevention Intervention - Children
140
Nutrition, Physical Activity, and Weight Talk Comparison - Children
139
Child Willingness to Use SubstancesPrimary· 18 months
Child willingness to use substances will be assessed through three items adapted from the measure combining intention and willingness originally developed for tobacco and amphetamines found in Gibbons et al. (1998) Reasoned Action and Social Reaction: Willingness and Intention as Independent Predictors of Health Risk. The three items will be asked for each substance. Each item has response options ranging from (1) Not at all likely to (6) Very likely. Response options are transformed to binary format such that 0 represents (1) Not at all likely and 1 represents (2) Unlikely to (6) Very Likely.
Alcohol - Willingness to use
Group
Value
95% CI
Substance Use Prevention Intervention - Children
0.27
± 0.64
Nutrition, Physical Activity, and Weight Talk Comparison - Children
0.26
± 0.63
Cigarettes - Willingness to use
Group
Value
95% CI
Substance Use Prevention Intervention - Children
0.22
± 0.61
Nutrition, Physical Activity, and Weight Talk Comparison - Children
0.13
± 0.41
Cannabis - Willingness to use
Group
Value
95% CI
Substance Use Prevention Intervention - Children
0.24
± 0.66
Nutrition, Physical Activity, and Weight Talk Comparison - Children
0.15
± 0.45
E-cigarettes or vaping - Willingness to use
Group
Value
95% CI
Substance Use Prevention Intervention - Children
0.34
± 0.85
Nutrition, Physical Activity, and Weight Talk Comparison - Children
0.21
± 0.56
Other drugs - Willingness to use
Group
Value
95% CI
Substance Use Prevention Intervention - Children
0.12
± 0.44
Nutrition, Physical Activity, and Weight Talk Comparison - Children
0.17
± 0.49
Child Intentions to Use SubstancesPrimary· 18 months
One item from the Youth Alcohol and Drug Survey will assess child's intention to use substances in the next 30 days. The question is asked for each substance and has the response options 'No', 'Probably No', 'Probably Yes', 'Yes'. Response options are dichotomized to (1) No \[which includes 'No' and 'Probably No'\] and (2) Yes \[which includes 'Probably Yes' and 'Yes'\].
This measure was reported by children only.
Alcohol - Plan to use in the next 30 days
Group
Value
95% CI
Substance Use Prevention Intervention - Children
0
Nutrition, Physical Activity, and Weight Talk Comparison - Children
0
Substance Use Prevention Intervention - Children
147
Nutrition, Physical Activity, and Weight Talk Comparison - Children
146
Cigarettes - Plan to use in the next 30 days
Group
Value
95% CI
Substance Use Prevention Intervention - Children
0
Nutrition, Physical Activity, and Weight Talk Comparison - Children
0
Substance Use Prevention Intervention - Children
147
Nutrition, Physical Activity, and Weight Talk Comparison - Children
148
Cannabis - Plan to use in the next 30 days
Group
Value
95% CI
Substance Use Prevention Intervention - Children
0
Nutrition, Physical Activity, and Weight Talk Comparison - Children
0
Substance Use Prevention Intervention - Children
147
Nutrition, Physical Activity, and Weight Talk Comparison - Children
147
E-cigarettes or vapes - Plan to use in the next 30 days
Group
Value
95% CI
Substance Use Prevention Intervention - Children
1
Nutrition, Physical Activity, and Weight Talk Comparison - Children
1
Substance Use Prevention Intervention - Children
146
Nutrition, Physical Activity, and Weight Talk Comparison - Children
147
Other drugs - Plan to use in the next 30 days
Group
Value
95% CI
Substance Use Prevention Intervention - Children
0
Nutrition, Physical Activity, and Weight Talk Comparison - Children
0
Substance Use Prevention Intervention - Children
144
Nutrition, Physical Activity, and Weight Talk Comparison - Children
140
Pre/Early-adolescent Substance Use InitiationSecondary· 18 months
Substance use initiation for each substance will be assessed with three items from the Drug Use Questionnaire. The items will be asked for each substance. Child responds Yes/No to the "have you ever used \[substance\]?" question.
This measure was reported by children only.
Alcohol
Group
Value
95% CI
Substance Use Prevention Intervention - Children
14
Nutrition, Physical Activity, and Weight Talk Comparison - Children
9
Substance Use Prevention Intervention - Children
173
Nutrition, Physical Activity, and Weight Talk Comparison - Children
173
Cigarettes
Group
Value
95% CI
Substance Use Prevention Intervention - Children
3
Nutrition, Physical Activity, and Weight Talk Comparison - Children
2
Substance Use Prevention Intervention - Children
184
Nutrition, Physical Activity, and Weight Talk Comparison - Children
180
Cannabis
Group
Value
95% CI
Substance Use Prevention Intervention - Children
9
Nutrition, Physical Activity, and Weight Talk Comparison - Children
3
Substance Use Prevention Intervention - Children
178
Nutrition, Physical Activity, and Weight Talk Comparison - Children
179
E-cigarettes or vaping
Group
Value
95% CI
Substance Use Prevention Intervention - Children
13
Nutrition, Physical Activity, and Weight Talk Comparison - Children
6
Substance Use Prevention Intervention - Children
174
Nutrition, Physical Activity, and Weight Talk Comparison - Children
176
Other drugs
Group
Value
95% CI
Substance Use Prevention Intervention - Children
1
Nutrition, Physical Activity, and Weight Talk Comparison - Children
1
Substance Use Prevention Intervention - Children
186
Nutrition, Physical Activity, and Weight Talk Comparison - Children
181
Sponsor's own description
The current study aims to test the efficacy of a family communication-based, novel, adaptable, and resource-efficient substance misuse preventive intervention for parents/guardians of pre/early adolescents (grades 5-7). The short-term goal of this study is to increase the quality time that parents spend with their children through eating meals together, and in so doing, talking about the harms associated with substance use (intermediate endpoint), which will in turn, lead to the long-term goal of preventing the initiation and misuse of substances among their children as they enter adolescence.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tufts University
Last refreshed: 9 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03925220.