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Family intervention (brief) for schizophrenia

  1. Uzuazomaro Okpokoro1,*,
  2. Clive E Adams2,
  3. Stephanie Sampson2

Editorial Group: Cochrane Schizophrenia Group

Published Online: 5 MAR 2014

Assessed as up-to-date: 4 MAR 2013

DOI: 10.1002/14651858.CD009802.pub2


How to Cite

Okpokoro U, Adams CE, Sampson S. Family intervention (brief) for schizophrenia. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD009802. DOI: 10.1002/14651858.CD009802.pub2.

Author Information

  1. 1

    The University of Nottingham, Division of Psychiatry, Nottingham, UK

  2. 2

    The University of Nottingham, Cochrane Schizophrenia Group, Nottingham, UK

*Uzuazomaro Okpokoro, Division of Psychiatry, The University of Nottingham, Room B21 The Sir Colin Campbell Building, Jubilee Campus, Nottingham, NG7 2TU, UK. maroexe@yahoo.com.

Publication History

  1. Publication Status: New
  2. Published Online: 5 MAR 2014

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Characteristics of included studies [ordered by study ID]
Barber 1988*

MethodsAllocation: random.
Blindness: not stated.
Duration: 2 months.

Setting: outpatient - university-affiliated, state supported, community outpatient psychiatric clinic for adults and children situated in a cosmopolitan area comprising approximately 2 million people (US).


ParticipantsN = 200*.

People with schizophrenia:

Diagnosis: schizophrenia (DSM III).
Age: mean 32.7 years (SD + 1.19), range 20 - 60 years.
Sex: 18F, 52M.

Ethnicity: not stated.
History: all receiving prescribed medication; mean age of onset 24.70 years (SD + 5.68); range 16 - 42 years.

Included: living with primary care giver or at least had weekly contact (face-to-face or telephone) with the relative.

Excluded: patients with a secondary diagnosis of mental retardation [sic] or organic brain syndrome were not included in the study.

Participants - 'primary family caregivers':
n = 70 (n = 44 parents; n = 8 spouse; n = 9 sibling; n = 4 child; n = 5 other).
Age: mean 49 years (SD + 12.5), range 23 - 67 years.      
Sex: 53F, 17M.

Ethnicity: White (n = 34); Black (n = 26); Hispanic (n = 6); Oriental (n = 4).
History: living with participant or at least had weekly contact (face to face or telephone) with the participant.

Included: those not currently attending a family educational group or had attended in past 6 months.

Excluded: primary family caregivers of patients with a secondary diagnosis of mental retardation [sic] or organic brain syndrome were included in the study.


Interventions1. Brief family intervention: 'family workshop' - conducted by three registered psychiatric nurses, a social worker and a psychiatrist. Semi-structured family workshop in which families are instructed regarding the diagnosis of schizophrenia, treatment, symptoms, problems, medications, course of illness, early sings of relapse and coping strategies - six-hour, one-day workshop lasting 5 sessions, n = 100.
2. Standard care: 'routine clinical information' without workshop; this includes information that is not formalised, usually brief; and limited to the responses to questions and concerns that the caregivers verbalise, n = 100.


OutcomesFamily outcome: understanding of the family member with schizophrenia - Patient Rejection Scale (PRS).

Unable to use -

Family stress: Schizophrenic Family Caregiver Stress Scale (SFCS) - non-peer-reviewed scale.


Notes*Due to high loss to follow-up, this study was subjected to a sensitivity analysis.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskSimple random sampling - "using a table of random numbers, 200 patient code numbers were randomly selected and divided into 2 groups of 100 each, random assignment of subjects to control and experimental group was determined by a flip of a coin such that 'heads' represented the control group and 'tails' represented the experimental group. The subjects were subsequently alternately assigned to the groups after the initial toss of coin so that the groups were equal" (p66).

Allocation concealment (selection bias)Unclear riskNot stated.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot stated.

Incomplete outcome data (attrition bias)
All outcomes
High riskAttrition: 65% - 200 participants were originally randomised - 100 each to receive either the family workshop or routine clinical information. Out of n = 100 assigned to workshop, n = 44 participants agreed to participate, however only n = 39 attended, and only n = 36 returned both pre-tests and post-tests and were included in the analysis. Out of n = 100 assigned to routine clinical information, only n = 38 agreed to participate in the study, and only n = 34 completed the study and were included in data and analysis.

Selective reporting (reporting bias)Low riskAll specified outcomes were reported.

Other biasHigh riskFunding: not stated.

Rating scales: not clear whether raters were independent of treatment. SFCS developed by trial investigator.

Shinde 2005

MethodsAllocation: random.
Blindness: none.
Duration: 1 month, 3-month follow-up.

Setting: inpatient and outpatient, Department of Psychiatry, NIMHANS, Bangalore (IN).


ParticipantsParticipants - people with schizophrenia:

Diagnosis: schizophrenia (ICD-10), paranoid schizophrenia (n = 32), other subtypes (n = 8).
n = 40.
Age: brief family intervention - mean 29.95 years (SD ± 6.85); control - mean 30.05 years (SD ± 7.22).
Sex: 11F, 29M.

Ethnicity: not stated.
History: n = 4 belonged to inpatient wards, n = 36 were on outpatient treatment; mean duration of treatment - brief family intervention 52.25 months (SD ± 27.43); control 45.45 months (SD ± 28.81); average number of relapses 1.6 in both groups; n = 14 receiving typical antipsychotics; n = 26 receiving atypical antipsychotics.

Included: diagnosis of schizophrenia (ICD-10); duration of illness 1-10 years; age 18-65 years.

Excluded: acute psychotic excitement or illness; co-morbid psychiatric or chronic medical illness; mental retardation [sic].

Participants - 'primary caregivers'*:

Age: brief family intervention - mean 47.60 years (SD ± 14.80); control - mean 47.05 years (SD ± 12.97).
Sex: 16F, 24M.

Ethnicity: not stated.
History: in contact and residing with person with schizophrenia since previous 1 month.

Included: parent, spouse, sibling, child or relative; aged 18-65 years; maximum hours of contact and residing with person with schizophrenia since previous 1 month.

Excluded: having another relative with psychiatric illness; chronic medical or psychiatric illness.


Interventions1. Brief family intervention: 'family psychoeducation module' - X3 (weekly) one-hour sessions to be completed over a period of four weeks (45-minute session with a 15-minute discussion and queries session), n = 20.

i) Session one: education about schizophrenia (including diagnosis; symptoms; course of illness and relapse; causes; treatment);

ii) Session two: assessing and handling difficult problems (including identifying problems; listing solutions; weighing advantages and disadvantages; selecting the best solution; implementation; review; maintenance and generalisation of solutions);

iii) Session three: handling communication and emotions (including improving communication techniques and patterns; non-verbal communication; expressing feelings; positive communication; handling expressed emotions).

2. Standard care: 'standard inpatient/outpatient treatment' (control group participants were informed that they were on a waiting list to receive the intervention program at the end of three months), n = 20.


OutcomesClinical global response: relapse (clinical judgement); antipsychotic dose increased.

Leaving the study early.

Mental state: positive symptoms; negative symptoms; total score (PANSS).

Family outcome: expressed emotion score (Family Emotional Involvement and Criticism Scale (FEICS)); burden (Burden Assessment Schedule (BAS)); family coping (Family Crisis Oriented Personal Evaluation Scales (FCOPES)).

Unable to use -

Knowledge acquisition (Knowledge Interview (KI)) - no usable data.


NotesAll participants continued medication management from their parent-treatment unit.

*Defined as a 'family member who lives in the same household as the index patient, who spends time with him/her, and/or is directly and actively involved in the care of the patient (supervising medication, bringing him/her to hospital for follow-up) for at least one month' (p31-2).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomised – "random number table was used to assort 20 patients and their caregivers" – no further information.

Allocation concealment (selection bias)High riskNon-blinded.

Blinding (performance bias and detection bias)
All outcomes
High riskNon-blinded.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskFollow-up: 88%. Brief family intervention group - all participants attended the first session; n = 16 attended the second session; n = 15 attended the third session. Three-month follow-up assessment was obtained from n = 18 patients and their caregivers.

Control group - n = 17 people with schizophrenia and their caregivers completed the 3-month follow-up assessment.

Selective reporting (reporting bias)Low riskNone detected.

Other biasUnclear riskFunding: not stated.

Rating scales: FEICS described as a self-report scale - unclear whether raters of remaining scales were independent of treatment.

Smith 1987

MethodsAllocation: random.
Blindness: not stated.
Duration: 6 months.

Setting: inpatient and outpatient (UK).


ParticipantsPeople with schizophrenia:

Diagnosis: evidence of one or more first rank symptoms of schizophrenia (Schneider 1959).

n = 23 (total of 23 families).

Age: mean 36.4 years (SD + 14).

Sex: 18F, 5M.

Ethnicity: not stated.

History: mean duration of illness 7.9 years (SD + 6.8); mean number of hospital admissions 3.7 (SD + 3.8).

Included: evidence of one or more 'first-rank' symptoms of schizophrenia (Schneider 1959); living at home or in close contact with the family (5 or more days a week); stabilised on depot or oral antipsychotic medication. Out of the people with schizophrenia who participated, n = 6 were in hospital at the time of the study.

Excluded: not stated.

Participants - 'family members':

n = 40 (28 parents; 7 spouses; 5 'other relatives').

Ethnicity: not stated.

Included: English-speaking.

Excluded: not stated.


Interventions1. Brief family intervention: 'brief education intervention', the therapy was administered by the primary therapist in a semi-structured seminar format involving oral presentation of the information as well as audiovisual aids, delivered at weekly intervals for 4 weeks (4 sessions). Family participation was encouraged through question and answer discussions. At the end of each session, each family member received a booklet corresponding to the material covered in that section with homework they were invited to complete, n = 20.
2. Brief family intervention by post: 'postal information booklet', delivered at weekly intervals for 4 weeks (4 sessions). Family members received a typed information booklet, corresponding to what the group education intervention group received. A covering letter was also distributed, inviting family members to complete corresponding homework exercised attached, n = 20.


OutcomesFamily outcome: stress (measured using the symptom rating scale - SRT, skewed, Kellner 1973); burden (measured using the Family Distress Scale - FDS, skewed, Pasamanick 1967).

Unable to use -

Beliefs about schizophrenia and its treatment - measured using a non-peer-reviewed scale.

Knowledge acquisition: clinical information survey - non-peer reviewed scale.

Worry and fear - measured using a non-peer-reviewed scale.

Behavioural disturbance - not specified in protocol.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomised - no further details.

Allocation concealment (selection bias)Unclear riskNot stated.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot stated.

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote, "there were no drop-outs during the intervention period" (p646).

Selective reporting (reporting bias)Unclear riskAll data were reported.

Other biasUnclear riskFunding: not stated.

Rating scales: not clear whether raters were independent of treatment.

Youssef 1987

MethodsAllocation: random.
Blindness: non-blinded.
Duration: 12 months follow-up*.
Setting: inpatient, psychiatric unit of a general hospital, Virginia (US).


ParticipantsParticipants - people with schizoaffective disorder;

Diagnosis: schizoaffective disorder.
n = 30.
Age: range 28-52 years, mean 37.
Sex: 12F, 18M.

Ethnicity: not stated.
History: mean length of illness 8 years; mean previous hospital admissions 3.7; mean length of hospitalisations 5.4 weeks.

Included: not stated.

Excluded: refusal to participate; reluctance to join all three education sessions.


Interventions1. Brief family intervention: patient-family** teaching programme, twice weekly, participants were required to attend 3 consecutive sessions lasting one hour. Discussion based, question and answer sessions to explain the meaning of the illness, causes and treatments:

i) To provide knowledge, clarification and support for patients and families (including diagnosis; medication; signs of relapse; community resources available for patients and families);

ii) Help the family understand the meaning of hospitalisation for the patient, and remain aware of ‘problem areas’ to be aware of after discharge, n = 15.

2. Standard care: 'did not receive the patient-family teaching programme', n = 15.


OutcomesGlobal state: improved (defined as a marked increase on the Global Assessment Scale (GAS) scores between the time of admission and the time of discharge).

Service utilisation: hospital admission.

Unable to use -
Global state: average change/endpoint score (GAS) - no usable data.


Notes*The study was carried out in a psychiatric unit of a general hospital, with an average length of stay of 4 weeks. The patient-family teaching program was implemented prior to discharge (length of intervention not specified).

**For this study, quote, "'family' was defined as a 'family member or significant others such as room mates, friends, or any other person with whom the patient has any type of enduring relationship'" (p613).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomised - no further details.

Allocation concealment (selection bias)Unclear riskNot stated.

Blinding (performance bias and detection bias)
All outcomes
High riskQuote: "subjects were approached by the investigator and informed verbally of the purpose of the study" (p613).

Incomplete outcome data (attrition bias)
All outcomes
High riskIt is stated that, quote, "initially a total of 42 patients with affective disorders were approached for possible inclusion in this investigation. Of this number, 12 patients were excluded from the initial sample for the following reasons: families' refusal to participate in this study, reluctance to join all three education sessions, and/or difficulties in tracing some patients and their families during the follow-up period" (p613). It is unclear whether these participants had been randomised into either the intervention or control group, or whether data were collected for these participants.

Selective reporting (reporting bias)High riskStatistical data for the GAS were not reported.

Other biasLow riskFunding: not stated.

Rating scales: not clear whether raters were independent of treatment.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Berkowitz 1984Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care.
Outcomes: no usable data.

Birchwood 1992Allocation: sequential.

Chen 2000Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

Chen 2002Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

Cozolino 1988Allocation: quasi-randomised.

Dixon 2011Allocation: randomised.

Participants: 'serious mental illness' - not specific to schizophrenia.

Gassmann 2011Allocation: randomised.

Participants: people with schizophrenia.

Intervention: psychoeducative family intervention vs standard care - not brief family intervention.

Kane 1990Allocation: not randomised.

Koolaee 2009Allocation: randomised.

Participants: mothers of people with schizophrenia.

Intervention: psychoeducation vs behavioural family management vs standard care - not brief family intervention.

Li 2003Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

Ling 1999Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

Pickett-Schenk 2006Allocation: randomised.

Participants: mixed diagnosis (schizophrenia, schizoaffective disorder, bipolar disorder, depression, OCD, other) - majority bipolar disorder.

Intervention: psychoeducation vs standard care - not brief family intervention.

Rotondi 2005Allocation: randomised.
Participants: people with schizophrenia.

Interventions: 'telehealth' family intervention (via Internet-based guide to schizophrenia) vs standard care - duration of family intervention not measured.

Spiegel 1987Allocation: randomised.
Participants: people with schizophrenia.

Interventions: 'family case consultation' vs standard care - duration of family intervention optional up to 15 sessions.

Tarrier 1988Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - not brief family intervention.

Wang 1997Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

Yang 2002Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

Zhang 2001Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

Zhao 2000Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

Zhu 1998Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

Zhu 2002Allocation: randomised.
Participants: people with schizophrenia.
Interventions: family intervention vs standard care - duration of family intervention not specified.

 
Comparison 1. BRIEF FAMILY INTERVENTION vs STANDARD CARE

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Service utilisation: 1. hospital admission1Risk Ratio (M-H, Random, 95% CI)Subtotals only

    1.1 long term (by 1 year)
130Risk Ratio (M-H, Random, 95% CI)0.5 [0.22, 1.11]

 2 Global state: 1. relapse1Risk Ratio (M-H, Random, 95% CI)Subtotals only

    2.1 medium term (by 3 months)
140Risk Ratio (M-H, Random, 95% CI)0.5 [0.10, 2.43]

 3 Global state: 2. improved (GAS)1Risk Ratio (M-H, Random, 95% CI)Subtotals only

    3.1 long term (by 1 year)
130Risk Ratio (M-H, Random, 95% CI)1.27 [0.91, 1.78]

 4 Global state: 3. antipsychotic dose increased1Risk Ratio (M-H, Random, 95% CI)Subtotals only

    4.1 medium term (by 3 months)
140Risk Ratio (M-H, Random, 95% CI)0.67 [0.29, 1.52]

 5 Mental state: 1. positive symptoms, average score (PANSS, high score = worse)1Mean Difference (IV, Random, 95% CI)Subtotals only

    5.1 medium term (by 3 months)
135Mean Difference (IV, Random, 95% CI)-0.89 [-2.84, 1.06]

 6 Mental state: 2. negative symptoms, average score (PANSS, high score = worse)1Mean Difference (IV, Random, 95% CI)Subtotals only

    6.1 medium term (by 3 months)
135Mean Difference (IV, Random, 95% CI)-0.62 [-3.35, 2.11]

 7 Mental state: 3. total average score (PANSS, high = worse)1Mean Difference (IV, Random, 95% CI)Subtotals only

    7.1 medium term (by 3 months)
135Mean Difference (IV, Random, 95% CI)-2.72 [-9.79, 4.35]

 8 Family outcome: 1. understanding, average score for understanding of family member with schizophrenia (PRS, high score = greater acceptance)1Mean Difference (IV, Random, 95% CI)Subtotals only

    8.1 medium term (by 3 months)
170Mean Difference (IV, Random, 95% CI)14.90 [7.20, 22.60]

 9 Family outcome: 2. burden/stress, average score (BAS, high score = greater burden)1Mean Difference (IV, Random, 95% CI)Subtotals only

    9.1 medium term (by 3 months)
135Mean Difference (IV, Random, 95% CI)-2.52 [-10.43, 5.39]

 10 Family outcome: 3. family coping, average score (FCOPES)Other dataNo numeric data

    10.1 medium term (by 3 months)
Other dataNo numeric data

 11 Family outcome: 4. expressed emotions, average score (FEICS, high score = greater EE)1Mean Difference (IV, Random, 95% CI)Subtotals only

    11.1 medium term (by 3 months)
135Mean Difference (IV, Random, 95% CI)-1.88 [-5.61, 1.85]

 12 Leaving the study early1Risk Ratio (M-H, Random, 95% CI)Subtotals only

    12.1 medium term (by 3 months)
140Risk Ratio (M-H, Random, 95% CI)0.67 [0.12, 3.57]

 
Analysis 1.10 Comparison 1 BRIEF FAMILY INTERVENTION vs STANDARD CARE, Outcome 10 Family outcome: 3. family coping, average score (FCOPES).
Family outcome: 3. family coping, average score (FCOPES)

StudyInterventionMeanSDN

medium term (by 3 months)

Shinde 2005Brief family intervention102.228.5718

Shinde 2005Standard care91.2920.1917

 
Comparison 2. BRIEF FAMILY INTERVENTION vs BRIEF FAMILY INTERVENTION BY POST

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Family outcome: 1. Stress - average score (SRT, high score = worse, skew)Other dataNo numeric data

    1.1 short term (by 1 month)
Other dataNo numeric data

    1.2 long term (by 6 months)
Other dataNo numeric data

 2 Family outcome: 2. Burden - average score (FDS, high score = worse, skew)Other dataNo numeric data

    2.1 short term (by 1 month)
Other dataNo numeric data

    2.2 long term (by 6 months)
Other dataNo numeric data

 
Analysis 2.1 Comparison 2 BRIEF FAMILY INTERVENTION vs BRIEF FAMILY INTERVENTION BY POST, Outcome 1 Family outcome: 1. Stress - average score (SRT, high score = worse, skew).
Family outcome: 1. Stress - average score (SRT, high score = worse, skew)

StudyInterventionMeanSDN

short term (by 1 month)

Smith 1987Brief family intervention (face-to-face)11.957.6720

Smith 1987Brief family intervention (by post)15.158.9220

long term (by 6 months)

Smith 1987Brief family intervention (face-to-face)15.3510.6020

Smith 1987Brief family intervention (by post)15.409.1920

 
Analysis 2.2 Comparison 2 BRIEF FAMILY INTERVENTION vs BRIEF FAMILY INTERVENTION BY POST, Outcome 2 Family outcome: 2. Burden - average score (FDS, high score = worse, skew).
Family outcome: 2. Burden - average score (FDS, high score = worse, skew)

StudyInterventionMeanSDN

short term (by 1 month)

Smith 1987Brief family intervention (face-to-face)8.756.5620

Smith 1987Brief family intervention (by post)11.958.4820

long term (by 6 months)

Smith 1987Brief family intervention (face-to-face)6.606.2120

Smith 1987Brief family intervention (by post)9.708.5520

 
Summary of findings for the main comparison. BRIEF FAMILY INTERVENTION compared with STANDARD CARE for schizophrenia

BRIEF FAMILY INTERVENTION compared to STANDARD CARE for schizophrenia

Patient or population: patients with schizophrenia
Settings: Inpatient, outpatient (India; UK; US)
Intervention: BRIEF FAMILY INTERVENTION
Comparison: STANDARD CARE

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

STANDARD CAREBRIEF FAMILY INTERVENTION

Service utilisation - hospital admission - medium to long term
hospital admission levels
Follow-up: 12 months
667 per 10001333 per 1000
(147 to 740)
RR 0.5
(0.22 to 1.11)
30
(1 study)
⊕⊝⊝⊝
very low2,3

Service utilisation - days in hospital - medium to long term - not reportedSee commentSee commentNot estimable-See commentNo study reported/ measured this outcome.

Global state - relapse - medium to long term
relapse rates (clinical judgement)
Follow-up: 4 months
200 per 10001100 per 1000
(20 to 486)
RR 0.5
(0.1 to 2.43)
40
(1 study)
⊕⊕⊝⊝
low3,4

Global state - compliance with medication - medium to long term - not reportedSee commentSee commentNot estimable-See commentNo study reported/ measured this outcome.

Quality of life/satisfaction with care - for recipients or carers - medium to long term - not reportedSee commentSee commentNot estimable-See commentNo study reported/measured this outcome.

Family outcome - understanding schizophrenia, average endpoint score
Patient Rejection Scale (PRS - high score = greater acceptance). Scale from: 24 to 168.
Follow-up: 2 months
The mean family outcome - understanding schizophrenia, average endpoint score in the control groups was
104.2 points
The mean family outcome - understanding schizophrenia, average endpoint score in the intervention groups was
14.9 higher
(7.2 to 22.6 higher)
70
(1 study)
⊕⊝⊝⊝
very low5,6

Economic outcomes - costs of care - long term - not reportedSee commentSee commentNot estimable-See commentNo study reported/ measured this outcome.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Mean baseline risk presented for single study.
2 Risk of bias: 'very serious' - no blinding of participants or study personnel; 29% participant data not accounted; statistical data not reported.
3 Imprecision: 'serious' - 95% confidence intervals for best estimate of effect include both 'no effect' and appreciable benefit/harm.
4 Risk of bias: 'serious' - no blinding of participants or study personnel.
5 Risk of bias: 'very serious' - no mention of allocation concealment/blinding; attrition at 65% - only n = 34 out of N = 200 completed the study and were included in data and analysis.
6 Indirectness: 'serious' - scale-derived data.
 
Table 1. Brief versus standard care Versus non-brief versus standard care

OutcomeBrief vs standard care (by one year)Non-brief vs standard care (by one year)

Relapsen = 40, 1 RCT, RR 0.50, 95% CI 0.10 to 2.43n = 2981, 32 RCTs, RR 0.55, 95% CI 0.48 to 0.62

Hospital admissionn = 30, 1 RCT, RR 0.50, 95% CI 0.22 to 1.11n = 532, 9 RCTs, RR 0.78, 95% CI 0.63 to 0.98

Family burdenn = 35, 1 RCT, MD -2.52, 95% CI -10.43 to 5.39n = 48, 1 RCT, MD -7.01, 95% CI -10.77 to -3.25

Family understanding
of patient
n = 70, 1 RCT, MD 14.90, 95% CI 7.20 to 22.60n = 39, 1 RCT, RR 1.11, 95% CI 0.45 to 2.70

Family conflicts/expressed
emotions
n = 35, 1 RCT, MD -1.88, 95% CI -5.61 to 1.85n = 164, 3 RCTs, RR 0.68, 95% CI 0.54

 CI: confidence interval
MD: mean difference
RCT: randomised controlled trial
RR: risk ratio
 
Table 2. Suggested design of study

MethodsAllocation: randomised, fully explicit description of methods of randomisation and allocation concealment.
Blinding: single, tested.
Setting: community rather than hospital.
Duration: 12 weeks intervention, and then follow-up to at least 52 weeks.

ParticipantsDiagnosis: schizophrenia (ICD).
N = 300.*
Age: adults.
Sex: both.

Interventions1. Brief family intervention (five sessions or less, of less than three months duration) n = 150.

2. Standard care, n = 150.

OutcomesGeneral: time to all-cause treatment failure marked by its discontinuation, relapse, general impression of clinician (CGI), career/other, compliance with treatment., healthy days,
Mental state: BPRS and PANSS.
Global state: CGI (Clinical Global Impression).
Quality of life. QOL (Quality of Life Questionnaire).
Family burden: FBQ (Family Burden Questionnaire).
Social functioning: return to everyday living for 80% of time.*
Adverse events: any adverse event recorded.
Economic outcomes.

Notes* Powered to be able to identify a difference of ˜ 20% between groups for primary outcome with adequate degree of certainty.

 BPRS: Brief Psychiatric Rating Scale
ICD: Internation Classification of Diseases
PANSS: Positive and Negative Syndrome Scale
 
Table 3. Future reviews

InterventionStudy

Internet-based family interventions for schizophrenia.Rotondi 2005