SchizophreniaPhase 3FamCentNCT00000387
Self-Management Therapy for Youth With Schizophrenia
A Phase 3 study testing Self-management therapy in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Self-management therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Jan 2005
- Phase
- Phase 3
- 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 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- -
- Patients must have:
- Schizophrenia as diagnosed according to DSM-IV criteria when screened by a mental health professional using the K-SADS and the DISA.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. The study will test the intervention's effectiveness in improving the adolescents' behavior, thinking, mood, and use of substances such as drugs and alcohol. The study also will look at the effects of the patient on the family.
The intervention involves training in recognizing symptoms of schizophrenia and in stress management, problem-solving, and social skills. Parents and siblings are included to gain knowledge and skills to support the adolescents.
Read more
The Self-Management Therapy intervention is administered in small multiple-family groups in 12 sessions over 7-1/2 months. The effects of the intervention on the patient and his/her family are assessed prior to treatment, after 6 sessions, after 12 sessions, and in a follow-up visit 6 months after completion of sessions.
A child may be eligible for this study if he/she:
Is 15 to 19 years old and has been diagnosed with schizophrenia.
Read the detailed description
To test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. The primary aim is to test its effectiveness in improving the adolescents' level of functioning in role performance, thinking/cognitive processing, behavior towards others, mood, and use of substances. The second aim is to assess the impact of the intervention on family functioning. The third aim is to describe the relationships among the process variables of the intervention.
Nakagawa-Kogan's self-management nursing model, Kanfer's self-regulation theory, and Liberman's theory of stress and vulnerability provide the theoretical basis for the self-management intervention developed specifically for a population with deficits in cognitive processing. The intervention involves training in symptom awareness, stress management skills, problem-solving, and social skills. Parents and siblings are included to gain knowledge and skills to support the adolescents.
The adolescent's level of functioning is assessed using the Child and Adolescent Functional Assessment Scale, the Birchwood Early Signs \& Symptoms Scale for schizophrenia, and the DISA. Family Functioning is assessed by computing a Composite Family Functioning Index using weighted scores from the FACES II, Family Apgar, Family Empowerment, and Family Social Support scales. One parent is designated by the family to be the family respondent on the scales. The adolescents are referred to the study by mental health professionals. The intervention is administered in small multiple-family groups in 12 sessions over 7-1/2 months. Data are collected at 4 points in time: at baseline, after 6 intensive sessions, after 6 monthly reinforcement sessions, and 6 months post-intervention. ANCOVA is used to test the study hypotheses. Multivariate relationships are examined among the process variables of the intervention.
- Conditions
- Schizophrenia
- Being tested
- Self-management therapy
- Keywords
- Adolescence, Family, Female, Human, Male, Schizophrenia, Self Care, Community Health Services
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management therapyBehavioural
Behavioral
Self-management therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| A,1,III | Experimental | Behavioral intervention - Self management therapy Receives: Behavioral: Self-management therapy |
| A,2,III | Active comparator | Regular treatment Receives: Behavioral: Self-management therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in CAFAS level of functioning for all adolescents.
Measured: Over the course of 14 months
Secondary outcomes (1)
Increase in family functioning for families in the treatment group according to the designated family respondent.
Measured: Over the course of 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startApr 1998
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Karen G. Schepp, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000387
- Sponsor's protocol ID
- R01MH056580
- Other IDs
- DSIR CT-S
- Acronym
- FamCent
- Status last verified
- Dec 2007
- First submitted
- 2 Nov 1999
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Therapy for Youth With Schizophrenia
- ClinicalTrials.gov ID
- NCT00000387
- Acronym / sponsor ID
- FamCent / R01MH056580
- Conditions
- Schizophrenia
- Keywords
- Adolescence, Family, Female, Human, Male, Schizophrenia, Self Care, Community Health Services
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Apr 1998
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 3 Nov 1999 (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.
The purpose of this study is to test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. The study will test the intervention's effectiveness in improving the adolescents' behavior, thinking, mood, and use of substances such as drugs and alcohol. The study also will look at the effects of the patient on the family.
The intervention involves training in recognizing symptoms of schizophrenia and in stress management, problem-solving, and social skills. Parents and siblings are included to gain knowledge and skills to support the adolescents.
The Self-Management Therapy intervention is administered in small multiple-family groups in 12 sessions over 7-1/2 months. The effects of the intervention on the patient and his/her family are assessed prior to treatment, after 6 sessions, after 12 sessions, and in a follow-up visit 6 months after completion of sessions.
A child may be eligible for this study if he/she:
Is 15 to 19 years old and has been diagnosed with schizophrenia.
Detailed description
To test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. The primary aim is to test its effectiveness in improving the adolescents' level of functioning in role performance, thinking/cognitive processing, behavior towards others, mood, and use of substances. The second aim is to assess the impact of the intervention on family functioning. The third aim is to describe the relationships among the process variables of the intervention.
Nakagawa-Kogan's self-management nursing model, Kanfer's self-regulation theory, and Liberman's theory of stress and vulnerability provide the theoretical basis for the self-management intervention developed specifically for a population with deficits in cognitive processing. The intervention involves training in symptom awareness, stress management skills, problem-solving, and social skills. Parents and siblings are included to gain knowledge and skills to support the adolescents.
The adolescent's level of functioning is assessed using the Child and Adolescent Functional Assessment Scale, the Birchwood Early Signs \& Symptoms Scale for schizophrenia, and the DISA. Family Functioning is assessed by computing a Composite Family Functioning Index using weighted scores from the FACES II, Family Apgar, Family Empowerment, and Family Social Support scales. One parent is designated by the family to be the family respondent on the scales. The adolescents are referred to the study by mental health professionals. The intervention is administered in small multiple-family groups in 12 sessions over 7-1/2 months. Data are collected at 4 points in time: at baseline, after 6 intensive sessions, after 6 monthly reinforcement sessions, and 6 months post-intervention. ANCOVA is used to test the study hypotheses. Multivariate relationships are examined among the process variables of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A,1,III | Experimental | Behavioral: Self-management therapyBehavioral intervention - Self management therapy |
| A,2,III | Active comparator | Behavioral: Self-management therapyRegular treatment |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- -
- Schizophrenia as diagnosed according to DSM-IV criteria when screened by a mental health professional using the K-SADS and the DISA.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Self-management therapyBehavioral | Behavioural | A,1,III, A,2,III |
| Self-management therapy | Behavioural | A,1,III, A,2,III |
Primary outcome
Increase in CAFAS level of functioning for all adolescents.
Time frame: Over the course of 14 months
1 secondary outcome
Increase in family functioning for families in the treatment group according to the designated family respondent.
Time frame: Over the course of 14 months
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 Dec 2007.
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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.
Karen G. Schepp, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self-management therapy in people with Schizophrenia, run by National Institute of Mental Health (NIMH) 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 3 inclusion and 0 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 Dec 2007. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Increase in CAFAS level of functioning for all adolescents. (time frame: Over the course of 14 months). 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 Dec 2007.