Substance-Related DisordersPhase 1/2FTPNCT01344382
Family Training Program for Parents of Substance Using Adolescents
A Phase 1/2 study testing Community Reinforcement and Family Training and Al-Anon Facilitation in people with Substance-Related Disorders and Drug Addiction, run by Treatment Research Institute at 1 site in United States.
Trial summary
This project will modify Community Reinforcement and Family Training (CRAFT; n=15) and Alanon/Naranon Facilitation (ANF; n=15) for use with parents who are concerned about an out-of-treatment adolescent. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders, Drug Addiction, Substance Abuse
- What is being tested?
- Community Reinforcement and Family Training and Al-Anon Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent Criteria
- parent is over 21 yrs old
- parent expresses concern about the drug abuse of their adolescent or young adult
- parent has the ability to have face-to-face contact with the child on at least 15 out of 30 days with no planned decrease in the amount of contact in the next 12 mo
- parent has an adolescent or young adult with primary drug abuse of alcohol or a psychoactive drug other than tobacco or caffeine
- the adolescent/young adult is between 12-25 yrs old at time of consent
Show all 9Show fewer
- the child is not receiving treatment addressing the drug abuse/dependence and is not willing for treatment at the time of parental study consent
- Adolescent/Young Adult Criteria
- 1. child's parent meets all eligibility criteria and consents to participate
Who cannot join
- Parent Criteria
- parent does not agree to participate
- parent who is providing consent does not demonstrate understanding of participation by reading the consent form and passing a consent quiz testing comprehension of basic elements of informed consent and requirements of the protocol
- parent is not willing and able to provide valid locator information, to allow training sessions to be recorded, and/or to complete follow-up assessments (determined via consent quiz)
- parent has a drug abuse problem themselves as determined through PSUD (DSM-IV-TR criteria)
- parent has a history of drug abuse or dependence and has not been in recovery for more than 2 yrs
Show all 16Show fewer
- parent is in a close relationship with another participant such that their participation is unlikely to be independent
- parent is not able to comprehend the content in the questionnaires even after it is explained several times
- parent or adolescent/young adult has been diagnosed as having or behaves in a manner consistent with having significant cognitive impairment (e.g., unremitting psychosis, dementia, or other severe psychiatric disorder)
- parent is currently receiving treatment that addresses the adolescent's substance use (e.g., family therapy)
- adolescent has a recent history of severe violence toward the parent(s) (e.g., involving weapons, serious injury, or hospitalization).
- Adolescent/Young Adult Criteria
- adolescent/young adult does not agree to participate
- adolescent/young adult who is providing consent or assent does not demonstrate understanding of participation by reading the consent/assent form and passing a quiz testing comprehension of basic elements of informed consent and requirements of the protocol
- adolescent/young adult is not able to comprehend the content in the questionnaires even after it is explained several times
- adolescent/young adult has been diagnosed as having or behaves in a manner consistent with having significant cognitive impairment (e.g., unremitting psychosis, dementia, or other severe psychiatric disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Training Program
Philadelphia, Pennsylvania, 19103
About this study
Official title: CRAFT: Helping Parents Initiate and Support Their Adolescent's Treatment
This project will modify Community Reinforcement and Family Training (CRAFT; n=15) and Alanon/Naranon Facilitation (ANF; n=15) for use with parents who are concerned about an out-of-treatment adolescent. ANF was selected as a comparison because Alanon and Naranon are the most commonly available method for helping family members. The investigators will compare CRAFT for parents (CRAFT-P) (n=77) and ANF (n=77) to determine if there is a significant difference in adolescent treatment entry. Parents will attend a maximum of 18 sessions with a family specialist and also complete questionnaires periodically over a 12-month period. Parents' adolescents will have the opportunity to participate in the study by completing questionnaires at the same time points as their parent. Our primary hypothesis asks whether participants who are enrolled in the CRAFT-P condition will report more adolescent treatment entry than the ANF condition. Our secondary hypotheses examine: 1) reductions in adolescent substance use and behavior problems in the CRAFT-P group compared to the ANF condition, 2) improvements in parenting skills in the CRAFT-P group compared to the ANF condition and 3) significant pre to post treatment effects for improvements in social functioning, mood, and in parent-adolescent relationship satisfaction.
Read the detailed description
Data suggest that as many as 60% of parents who are aware and concerned about their adolescent's substance use are unable to get them into treatment without assistance (Szapocznik et al., 1988) and very little research has examined methods to help them. Community Reinforcement and Family Training (CRAFT) was developed to help family members foster treatment entry of treatment-resistant adults, but it has not been tested in a controlled trial with parents of substance-abusing adolescents. This project will modify CRAFT (CRAFT-P) and Alanon/Naranon Facilitation (ANF) for use with parents who are concerned about an out-of-treatment adolescent.
The purpose of this study is to examine the efficacy of the CRAFT-P program in helping parents to: 1) facilitate treatment entry of their child, 2) achieve the outcomes they desire for their adolescents, 3) improve parenting skills in general and in acquisition of CRAFT knowledge in particular, and 4) improve their own mood and functioning. In addition the investigators will examine parents whose child entered treatment to estimate effect sizes of the new CRAFT methods for facilitating parent-supported treatment retention and aftercare engagement in community-based settings. Finally, if the CRAFT program appears efficacious, additional translational work will be initiated in collaboration with the Partnership at Drugfree.org (formerly the Partnership for a Drug-Free America) to provide parents with direct access to components of the CRAFT program.
A Stage II two-group randomized controlled clinical trial will compare CRAFT-P vs ANF. The investigators will collect data from approximately 308 participants (154 parents and 154 adolescents) and each participant will be involved in the study for a maximum of 12 months. The total enrollment number is not exact because it is possible that some adolescents will decline to participate.
Parents will be screened to determine their eligibility. If eligible and interested in participating in the study, the parent will then provide informed consent and give permission for their adolescent to participate in the study. Parents will be randomized to one of the two interventions, CRAFT-P or ANF. Each session will be audio-recorded and stored so that the investigators can complete on-going monitoring to minimize condition bleeding and protect against trainer drift. In addition to completing screening and baseline assessments, parents and adolescents will complete full assessment batteries at 3-, 6-, \& 12-months post-baseline. The adolescents' research participation involves completing the assessment battery only and these data will be compared to parent reports to examine consistency.
- Conditions
- Substance-Related Disorders, Drug Addiction, Substance Abuse
- Being tested
- Community Reinforcement and Family Training, Al-Anon Facilitation
- Keywords
- Adolescent, Parent, Substance Abuse, Parent Training, Community Reinforcement and Family Training, CRAFT, Community Reinforcement Approach, Addiction, Family Intervention
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Reinforcement and Family TrainingBehavioural
Also called CRAFT
The philosophy of Community Reinforcement and Family Training (CRAFT) is that drug abuse is caused by multiple biological and environmental factors, many of which are beyond the parents' control. However, because parents have an important relationship with their child, they may able to influence his or her behavior. CRAFT for parents (CRAFT-P) will teach the parent new ways to interact with their child. Sessions will be designed to build the parents' motivation to comply with the training, conduct a functional analysis of their child's drug use pattern, train methods of behavior management and communication skills, enrich the parent's life and to suggest and motivate treatment entry.
Al-Anon FacilitationBehavioural
Also called ANF
Al-Anon Facilitation (ANF) parallels the Twelve Step Facilitation intervention developed by Nowinski et al. (1992) for Project MATCH. The content focuses on introducing parents to Alanon or Naranon's purpose and philosophy, educating about 12-step concepts, the fellowship community, denial and enabling, acceptance, caring detachment, and surrendering to a higher power. The trainer's role is to help the parent to gain insight into the ways they interact with their child and to educate and encourage the parent to become actively involved in a 12-step community and to take advantage of its many offerings.
| Study group | Role | What they receive |
|---|---|---|
| CRAFT | Experimental | All parents will be scheduled for 12 individual Community Reinforcement and Family Training for parents (CRAFT-P) training sessions within 120 days and allowed to use up to 6 additional emergency sessions at any time up to the 12-mo follow-up. The first session will last 90 min; the remaining sessions will be 50 - 60 min in duration. Emergency sessions typically last 30 - 60 min and are used to assist the parent with crisis situations during the treatment period (e.g., adolescent violence, arrest) or for booster sessions after. Receives: Behavioral: Community Reinforcement and Family Training |
| Al-Anon Facilitation | Active comparator | All parents will be scheduled for 12 individual Alanon/Naranon Facilitation Training (ANF) sessions within 120 days and allowed to use up to 6 additional emergency sessions at any time up to the 12-mo follow-up. The first session will last 90 min; the remaining sessions will be 50 - 60 min in duration. Emergency sessions typically last 30 - 60 min and are used to assist the parent with crisis situations during the treatment period (e.g., adolescent violence, arrest) or for booster sessions after. Receives: Behavioral: Al-Anon Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Entry
The primary outcome measure is treatment entry of the adolescent substance user. This data will be collected via the Supplemental Services Form which is completed by parent participants prior to each session with their specialist and during follow-up assessments. The form is also completed by the adolescent at each follow-up up assessment. Parents or adolescents may also inform study staff of treatment entry at any time during the study.
Measured: Each session and 3-, 6-, and 12-months post-baseline
Secondary outcomes (6)
Adolescent Substance Use
We will assess adolescent substance use in two ways. Parents will complete the Timeline Follow Back about their adolescent's drug use and the adolescents will also complete the Timeline Follow Back if they're a study participant. In addition, adolescent study participants will give a urine sample to be tested for 8 drugs during each follow-up assessment.
Measured: Baseline and 3-, 6-, and 12- months post-baseline
Adolescent Behavior Problems
Adolescent behavior problems will be measured with the Child Behavior Checklist or Adult Behavior Checklist(completed by parent participants) and the Youth Self Report or Adult Self Report(completed by adolescent/Young Adult participants).
Measured: Baseline and 3-, 6-, and 12-months post baseline
Improvement in Parenting Skills
The Adolescent Parenting Questionnaire will be completed by parent participants. In addition, parents will complete the Family Training Survey and the Parent Role Play Assessment to assess CRAFT knowledge.
Measured: Baseline and 3-, 6-, and 12-months post-baseline
Parent Social Functioning
Social functioning will be measured using the Stress Index for Parents of Adolescents
Measured: Baseline and 3-, 6-, and 12-months post-baselin
Parent Mood
Parent mood will be measured with the Profile of Mood States Questionnaire Brief Form.
Measured: Baseline and 3-, 6-, and 12-months post-baseline
Relationship Satisfaction
Parent participants will complete the Parent Happiness with Youth Scale to measure relationship satisfaction.
Measured: Baseline and 3-, 6-, 12-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Robert J. Meyers PhD & Associates, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kimberly C Kirby, PhD, Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344382
- Sponsor's protocol ID
- 5P50DA027841-02
- Other IDs
- P50DA027841
- Acronym
- FTP
- Status last verified
- Mar 2023
- First submitted
- 27 Apr 2011
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRAFT: Helping Parents Initiate and Support Their Adolescent's Treatment
- ClinicalTrials.gov ID
- NCT01344382
- Acronym / sponsor ID
- FTP / 5P50DA027841-02
- Conditions
- Substance-Related Disorders, Drug Addiction, Substance Abuse
- Keywords
- Adolescent, Parent, Substance Abuse, Parent Training, Community Reinforcement and Family Training, CRAFT, Community Reinforcement Approach, Addiction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- Robert J. Meyers PhD & Associates, National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will modify Community Reinforcement and Family Training (CRAFT; n=15) and Alanon/Naranon Facilitation (ANF; n=15) for use with parents who are concerned about an out-of-treatment adolescent. ANF was selected as a comparison because Alanon and Naranon are the most commonly available method for helping family members. The investigators will compare CRAFT for parents (CRAFT-P) (n=77) and ANF (n=77) to determine if there is a significant difference in adolescent treatment entry. Parents will attend a maximum of 18 sessions with a family specialist and also complete questionnaires periodically over a 12-month period. Parents' adolescents will have the opportunity to participate in the study by completing questionnaires at the same time points as their parent. Our primary hypothesis asks whether participants who are enrolled in the CRAFT-P condition will report more adolescent treatment entry than the ANF condition. Our secondary hypotheses examine: 1) reductions in adolescent substance use and behavior problems in the CRAFT-P group compared to the ANF condition, 2) improvements in parenting skills in the CRAFT-P group compared to the ANF condition and 3) significant pre to post treatment effects for improvements in social functioning, mood, and in parent-adolescent relationship satisfaction.
Detailed description
Data suggest that as many as 60% of parents who are aware and concerned about their adolescent's substance use are unable to get them into treatment without assistance (Szapocznik et al., 1988) and very little research has examined methods to help them. Community Reinforcement and Family Training (CRAFT) was developed to help family members foster treatment entry of treatment-resistant adults, but it has not been tested in a controlled trial with parents of substance-abusing adolescents. This project will modify CRAFT (CRAFT-P) and Alanon/Naranon Facilitation (ANF) for use with parents who are concerned about an out-of-treatment adolescent.
The purpose of this study is to examine the efficacy of the CRAFT-P program in helping parents to: 1) facilitate treatment entry of their child, 2) achieve the outcomes they desire for their adolescents, 3) improve parenting skills in general and in acquisition of CRAFT knowledge in particular, and 4) improve their own mood and functioning. In addition the investigators will examine parents whose child entered treatment to estimate effect sizes of the new CRAFT methods for facilitating parent-supported treatment retention and aftercare engagement in community-based settings. Finally, if the CRAFT program appears efficacious, additional translational work will be initiated in collaboration with the Partnership at Drugfree.org (formerly the Partnership for a Drug-Free America) to provide parents with direct access to components of the CRAFT program.
A Stage II two-group randomized controlled clinical trial will compare CRAFT-P vs ANF. The investigators will collect data from approximately 308 participants (154 parents and 154 adolescents) and each participant will be involved in the study for a maximum of 12 months. The total enrollment number is not exact because it is possible that some adolescents will decline to participate.
Parents will be screened to determine their eligibility. If eligible and interested in participating in the study, the parent will then provide informed consent and give permission for their adolescent to participate in the study. Parents will be randomized to one of the two interventions, CRAFT-P or ANF. Each session will be audio-recorded and stored so that the investigators can complete on-going monitoring to minimize condition bleeding and protect against trainer drift. In addition to completing screening and baseline assessments, parents and adolescents will complete full assessment batteries at 3-, 6-, \& 12-months post-baseline. The adolescents' research participation involves completing the assessment battery only and these data will be compared to parent reports to examine consistency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRAFT | Experimental | Behavioral: Community Reinforcement and Family TrainingAll parents will be scheduled for 12 individual Community Reinforcement and Family Training for parents (CRAFT-P) training sessions within 120 days and allowed to use up to 6 additional emergency sessions at any time up to the 12-mo follow-up. The first session will last 90 min; the remaining sessions will be 50 - 60 min in duration. Emergency sessions typically last 30 - 60 min and are used to assist the parent with crisis situations during the treatment period (e.g., adolescent violence, arrest) or for booster sessions after. |
| Al-Anon Facilitation | Active comparator | Behavioral: Al-Anon FacilitationAll parents will be scheduled for 12 individual Alanon/Naranon Facilitation Training (ANF) sessions within 120 days and allowed to use up to 6 additional emergency sessions at any time up to the 12-mo follow-up. The first session will last 90 min; the remaining sessions will be 50 - 60 min in duration. Emergency sessions typically last 30 - 60 min and are used to assist the parent with crisis situations during the treatment period (e.g., adolescent violence, arrest) or for booster sessions after. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Parent Criteria
- parent is over 21 yrs old
- parent expresses concern about the drug abuse of their adolescent or young adult
- parent has the ability to have face-to-face contact with the child on at least 15 out of 30 days with no planned decrease in the amount of contact in the next 12 mo
- parent has an adolescent or young adult with primary drug abuse of alcohol or a psychoactive drug other than tobacco or caffeine
Key exclusion criteria (16 listed)
- Parent Criteria
- parent does not agree to participate
- parent who is providing consent does not demonstrate understanding of participation by reading the consent form and passing a consent quiz testing comprehension of basic elements of informed consent and requirements of the protocol
- parent is not willing and able to provide valid locator information, to allow training sessions to be recorded, and/or to complete follow-up assessments (determined via consent quiz)
- parent has a drug abuse problem themselves as determined through PSUD (DSM-IV-TR criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Reinforcement and Family TrainingAlso: CRAFTThe philosophy of Community Reinforcement and Family Training (CRAFT) is that drug abuse is caused by multiple biological and environmental factors, many of which are beyond the parents' control. However, because parents have an important relationship with their child, they may able to influence his or her behavior. CRAFT for parents (CRAFT-P) will teach the parent new ways to interact with their child. Sessions will be designed to build the parents' motivation to comply with the training, conduct a functional analysis of their child's drug use pattern, train methods of behavior management and communication skills, enrich the parent's life and to suggest and motivate treatment entry. | Behavioural | CRAFT |
| Al-Anon FacilitationAlso: ANFAl-Anon Facilitation (ANF) parallels the Twelve Step Facilitation intervention developed by Nowinski et al. (1992) for Project MATCH. The content focuses on introducing parents to Alanon or Naranon's purpose and philosophy, educating about 12-step concepts, the fellowship community, denial and enabling, acceptance, caring detachment, and surrendering to a higher power. The trainer's role is to help the parent to gain insight into the ways they interact with their child and to educate and encourage the parent to become actively involved in a 12-step community and to take advantage of its many offerings. | Behavioural | Al-Anon Facilitation |
Primary outcome
Treatment Entry
Time frame: Each session and 3-, 6-, and 12-months post-baseline
The primary outcome measure is treatment entry of the adolescent substance user. This data will be collected via the Supplemental Services Form which is completed by parent participants prior to each session with their specialist and during follow-up assessments. The form is also completed by the adolescent at each follow-up up assessment. Parents or adolescents may also inform study staff of treatment entry at any time during the study.
6 secondary outcomes
Adolescent Substance Use
Time frame: Baseline and 3-, 6-, and 12- months post-baseline
Adolescent Behavior Problems
Time frame: Baseline and 3-, 6-, and 12-months post baseline
Improvement in Parenting Skills
Time frame: Baseline and 3-, 6-, and 12-months post-baseline
Parent Social Functioning
Time frame: Baseline and 3-, 6-, and 12-months post-baselin
Parent Mood
Time frame: Baseline and 3-, 6-, and 12-months post-baseline
Relationship Satisfaction
Time frame: Baseline and 3-, 6-, 12-months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly C Kirby, PhD principal investigator
Treatment Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Community Reinforcement and Family Training and Al-Anon Facilitation in people with Substance-Related Disorders and Drug Addiction, run by Treatment Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Entry (time frame: Each session and 3-, 6-, and 12-months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.