INTERVENTIONALCOMPLETEDNCT05380583

Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study

The purpose of this study is to evaluate Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) for families experiencing early psychosis and substance use delivered exclusively or primarily via telehealth (video conferencing).

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-02-27

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: NA
Enrollment: 65 (ACTUAL)
Start date: 2022-05-19
Sponsor: Mclean Hospital
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Present in registry snapshot

The intervention aims to improve treatment engagement, substance use patterns, and family wellbeing. To assess preliminary outcomes of the intervention, this study compares CRAFT-EP plus treatment as usual (TAU) compared to TAU alone. Family members will be randomized to CRAFT-EP + TAU or TAU alone. Data on family members and clients with psychosis will be collected for assessment purposes; if a client with psychosis does not have a family member participating in the study, the client with psychosis will be automatically be assigned to the TAU alone group. Total target enrollment is 40 family members and 40 clients with psychosis. Given that family members may participate without a corresponding client with psychosis due to fear of disclosing their participation in the study to the client or client lack of interest, and because the intervention works directly with family members and indirectly with clients, data collected from clients with or without a corresponding family member participating in the study will be hypothesis generating.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Bipolar Disorder

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

BEHAVIORAL

CRAFT-EP

CRAFT-EP is a behavioral intervention delivered via telehealth with the option for one in-person session (when local guidelines allow in-person care without masks). The coaching session topics include self-care, communication, functional analysis, positive reinforcement, treatment engagement, natural consequences, problem solving, and planning next steps. The intervention is designed for families of individuals experiencing psychosis and substance use who are enrolled or seeking enrollment in early psychosis outpatient services. Participants will be asked to complete assessments at pre-, mid- (approximately week 4), post-intervention, and a follow-up assessment approximately 12 weeks post-intervention.

Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP)

BEHAVIORAL

TAU

Participants may continue to receive their ongoing treatment, if any, which may include psychosocial and/or pharmacological interventions.

Treatment as Usual (TAU)

Source-reported results

Results posted to the registry

3 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 1
Secondary outcomes: 2
Statistical analyses: 3
Adverse-event terms: 3

PRIMARYFamily Wellbeing: Depression

Time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)
Measure: MEAN · score on a scale
Reporting status: POSTED

Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.

Population: Family member participant data are reported in the Results Outcome Measures Section. Clients with psychosis were enrolled and completed assessments for hypothesis generating purposes. They did not complete the intervention, and they have no pre-specified primary or secondary outcome data; thus, no data from client with psychosis are reported in the Results Outcome Measures Section. Part 1 of the IRB study protocol was already reported in clinicaltrials.gov record 2020P000220 (NCT04284813).

Group	N	Value	Spread / interval
CRAFT-EP + TAU	21	14.19	9.52
Treatment as Usual	22	10.82	7.36
CRAFT-EP + TAU	21	9.76	6.76
Treatment as Usual	22	11.67	5.88
CRAFT-EP + TAU	21	6.53	7.39
Treatment as Usual	22	8.64	5.40

Statistical analyses

CRAFT-EP + TAU vs Treatment as Usualgeneralized estimating equationsMean Difference (Net): -5.48p-value: 0.02695% CI · -10.31 · -0.65

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepted

Inclusion criteria

for Family Members:
Ages 18-70.
Having a relative who: 1. Is a client with early course psychosis (schizophrenia, schizoaffective disorder, schizophreniform, psychosis not otherwise specified (NOS), delusional disorder, brief psychotic disorder, major depression with psychosis, and bipolar disorder with psychosis (as reported by family member, clinician, or chart review)) with first onset in the past 6 years, and 2. Used alcohol or cannabis in the past 30 days and/or has no apparent immediate interest in abstinence (responding "No" to "Do you think they want to quit right now?" in reference to overall substance use). 3. Family member has concerns about the relative's substance use.
The person(s) who can best describe the client with psychosis.
At least 4 days per month contact with the client.
Access to a computer with internet or mobile phone with video conferencing capabilities.
Ability to provide written informed consent.
Speak and read English.

Exclusion criteria

for Family Members:
DSM-5 moderate or severe substance use disorder in the past year.
Lifetime psychotic disorder.
History of domestic violence with the client relative that would interfere with the ability to safely follow through with the intervention plan.
Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the intervention plan.
Prior participation of a family member of the client in the study program.
Significant prior experience with CRAFT (e.g., having completed a CRAFT course prior to study enrollment)

Inclusion criteria

for Client Relatives:
Ages 18-35.
First episode psychosis onset in the past 6 years with a Diagnostic and Statistical Manual (DSM)-5 diagnosis of affective (bipolar disorder or major depressive disorder with psychotic features) or non- affective psychosis (schizophrenia spectrum disorder)
Used alcohol or cannabis in the past 30 days and/or has no apparent immediate interest in abstinence (responding "No" to "Do you want to quit right now?" in reference to overall substance use).

primary outcomes

primary measures

Family Wellbeing: Depression

Time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)

Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.

secondary outcomes

secondary measures

Family Wellbeing: Anxiety

Time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)

State-Trait Anxiety Inventory-Short Form; total scores range from 6 to 24 with higher scores representing more severe anxiety symptoms. Raw total scores transformed to the original 20-item scale range from 20 to 80 with higher scores representing more severe anxiety symptoms.

Family Wellbeing: Relationship

Time frame: Baseline, mid-intervention (week 4), post-intervention (week 8)

General Happiness item on Relationship Happiness Scale; scores range from 1 to 10 with higher scores representing greater relationship happiness.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 6e4547ae-8123-4bf5-b271-a779fbc30c95
Retrieved: 11/09/2026, 14:17:05
SHA-256: 9da8cfe08e1a8c4451e660694d21246dcc57e732424b6974ae14b3752b9254fc

Event	System	Groups: affected / at risk
Residential alcohol use disorder treatment program	Psychiatric disorders	CRAFT-EP + TAU: 1 / 21 · Treatment as Usual: 0 / 22 · CRAFT-EP + TAU Clients With Psychosis: 0 / 4 · Treatment as Usual Clients With Psychosis: 0 / 18
Increase in Suicidal Ideation	Psychiatric disorders	CRAFT-EP + TAU: 0 / 21 · Treatment as Usual: 3 / 22 · CRAFT-EP + TAU Clients With Psychosis: 2 / 4 · Treatment as Usual Clients With Psychosis: 5 / 18
Car Accident	Psychiatric disorders	CRAFT-EP + TAU: 1 / 21 · Treatment as Usual: 0 / 22 · CRAFT-EP + TAU Clients With Psychosis: 0 / 4 · Treatment as Usual Clients With Psychosis: 1 / 18

Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

CRAFT-EP

TAU

Results posted to the registry

Statistical analyses

Population and criteria

Inclusion criteria

Exclusion criteria

Inclusion criteria

primary measures

Family Wellbeing: Depression

secondary measures

Family Wellbeing: Anxiety

Family Wellbeing: Relationship

Locally readable linked articles

Statistical analyses

Statistical analyses

Overall Study

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Region of Enrollment

CRAFT-EP + TAU

Treatment as Usual

CRAFT-EP + TAU Clients With Psychosis

Treatment as Usual Clients With Psychosis

Exclusion criteria

Group	N	Value	Spread / interval
CRAFT-EP + TAU	21	45.30	15.99
Treatment as Usual	22	41.82	17.27
CRAFT-EP + TAU	21	38.73	11.52
Treatment as Usual	22	45.24	16.79
CRAFT-EP + TAU	21	32.81	10.08
Treatment as Usual	22	42.42	16.62

Group	N	Value	Spread / interval
CRAFT-EP + TAU	21	3.71	2.55
Treatment as Usual	22	4.23	2.72
CRAFT-EP + TAU	21	5.43	2.60
Treatment as Usual	22	4.00	1.95
CRAFT-EP + TAU	21	6.05	2.32
Treatment as Usual	22	5.00	2.81